ADhere: Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04250337
Collaborator
Dermira, Inc. (Industry)
228
63
2
19.4
3.6
0.2
Study Details
Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double-blind, parallel group, placebo controlledRandomized, double-blind, parallel group, placebo controlled
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
Actual Study Start Date
:
Feb 3, 2020
Actual Primary Completion Date
:
Aug 11, 2021
Actual Study Completion Date
:
Sep 16, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lebrikizumab + Topical Corticosteroid 500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
Biological: Lebrikizumab
Subcutaneous injection
Other Names:
Other: Topical Corticosteroid
Topical Corticosteroid
|
| Placebo Comparator: Placebo + Topical Corticosteroid Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response |
Other: Placebo
Subcutaneous injection
Other: Topical Corticosteroid
Topical Corticosteroid
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16. [Baseline to Week 16]
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16 [Baseline to Week 16]
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Secondary Outcome Measures
- Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16 [Baseline to Week 16]
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
- Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 [Baseline, Week 16]
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors.
- Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16 [Baseline to Week 16]
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16 [Baseline to Week 16]
Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
- Percent Change in EASI Score From Baseline at Week 16 [Baseline, Week 16]
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.
- Change From Baseline to Week 16 in Percent Body Surface Area (BSA) [Baseline, Week 16]
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
- Percentage of Participants Achieving EASI-90 at Week 4 [Baseline to Week 4]
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
- Percent Change in Sleep-loss Score From Baseline to Week 16 [Baseline, Week 16]
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. .
- Change From Baseline in Sleep-loss Score at Week 16 [Baseline, Week 16]
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
- Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 [Baseline to Week 4]
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.
- Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 [Baseline to Week 2]
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.
- Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 [Baseline to Week 1]
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 [Baseline to Week 4]
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 [Baseline to Week 2]
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 [Baseline to Week 1]
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.
- Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16 [Baseline to Week 16]
Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.
- Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16 [Baseline to Week 16]
Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant).
- Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 [Baseline, Week 16]
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the ANCOVA model with treatment group, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [Baseline, Week 16]
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points [Baseline to Week 16]
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index [Baseline, Week 16]
The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS) [Baseline, Week 16]
The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 [Baseline, Week 16]
POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults [Baseline, Week 16]
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in PROMIS Depression at Week 16 - Adults [Baseline, Week 16]
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics [Baseline, Week 16]
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in PROMIS Depression at Week 16 - Pediatrics [Baseline, Week 16]
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma [Baseline, Week 16]
The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 [Baseline, Week 16]
The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg).
-
Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
-
Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
-
Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
-
≥10% body surface area (BSA) of AD involvement at the baseline visit.
-
History of inadequate response to treatment with topical medications.
Exclusion Criteria:
-
Participation in a prior lebrikizumab clinical study.
-
Treatment with the following prior to the baseline visit:
-
An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
-
Dupilumab within 8 weeks.
-
B-cell-depleting biologics, including to rituximab, within 6 months.
-
Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
-
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
-
Uncontrolled chronic disease that might require bursts of oral corticosteroids.
-
Evidence of active acute or chronic hepatitis
-
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
-
History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
-
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigate MD | Scottsdale | Arizona | United States | 85255 |
| 2 | Orange County Research Institute | Anaheim | California | United States | 92801 |
| 3 | Bakersfield Dermatology and Skin Cancer Medical Group | Bakersfield | California | United States | 93309 |
| 4 | Wallace Medical Group, Inc. | Beverly Hills | California | United States | 90211 |
| 5 | First OC Dermatology | Fountain Valley | California | United States | 92708 |
| 6 | Center For Dermatology Clinical Research, Inc. | Fremont | California | United States | 94538 |
| 7 | California Allergy and Asthma Medical Group + Research Center | Los Angeles | California | United States | 90025 |
| 8 | Keck School of Medicine University of Southern California | Los Angeles | California | United States | 90033 |
| 9 | Dermatology Research Associates | Los Angeles | California | United States | 90045 |
| 10 | LA Universal Research Center, INC | Los Angeles | California | United States | 90057 |
| 11 | ACRC Studies | San Diego | California | United States | 92119 |
| 12 | University Clinical Trials, Inc. | San Diego | California | United States | 92123 |
| 13 | Southern California Dermatology, Inc. | Santa Ana | California | United States | 92701 |
| 14 | Foxhall Dermatology | Washington | District of Columbia | United States | 20016 |
| 15 | St. Francis Medical Institute | Clearwater | Florida | United States | 33765 |
| 16 | University of Florida - Gainesville | Gainesville | Florida | United States | 32606 |
| 17 | Direct Helpers Medical Center | Hialeah | Florida | United States | 33012 |
| 18 | The Community Research of South Florida | Hialeah | Florida | United States | 33016 |
| 19 | GSI Clinical Research, LLC | Margate | Florida | United States | 33063 |
| 20 | Vitae Research Center, LLC | Miami | Florida | United States | 33135 |
| 21 | Well Pharma Medical Research Corp. | Miami | Florida | United States | 33143 |
| 22 | ForCare Clinical Research | Tampa | Florida | United States | 33613-1244 |
| 23 | Advanced Medical Research | Sandy Springs | Georgia | United States | 30328 |
| 24 | The Indiana Clinical Trials Center | Plainfield | Indiana | United States | 46168 |
| 25 | Dermatology and Skin Cancer Specialists | Rockville | Maryland | United States | 20850 |
| 26 | ActivMed Practices and Research | Beverly | Massachusetts | United States | 01915 |
| 27 | Beacon Clinical Research LLC | Quincy | Massachusetts | United States | 02169 |
| 28 | Fivenson Dermatology | Ann Arbor | Michigan | United States | 48103 |
| 29 | Clarkston Skin Research | Clarkston | Michigan | United States | 48346 |
| 30 | MediSearch Clinical Trials | Saint Joseph | Missouri | United States | 64506 |
| 31 | ALLCUTIS Research | Portsmouth | New Hampshire | United States | 03801 |
| 32 | Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | United States | 08520 |
| 33 | Sadick Research Group | New York | New York | United States | 10075 |
| 34 | OnSite Clinical Solutions | Charlotte | North Carolina | United States | 28277 |
| 35 | Wilmington Dermatology Center | Wilmington | North Carolina | United States | 28405 |
| 36 | Clinical Research Institute | Medford | Oregon | United States | 97504 |
| 37 | Oregon Dermatology and Research Center | Portland | Oregon | United States | 97210 |
| 38 | Oregon Medical Research Center | Portland | Oregon | United States | 97223 |
| 39 | OHSU Center for Health and Healing | Portland | Oregon | United States | 97239 |
| 40 | Clinical Partners, LLC | Johnston | Rhode Island | United States | 02919 |
| 41 | Clinical Research Center of the Carolinas | Charleston | South Carolina | United States | 29407 |
| 42 | Arlington Research Center, Inc | Arlington | Texas | United States | 76011 |
| 43 | Dermatology Treatment and Research Center | Dallas | Texas | United States | 75230 |
| 44 | CARe Clinic | Red Deer | Alberta | Canada | T4N 6V7 |
| 45 | Dr. Chih-ho Hong Medical Inc. | Surrey | British Columbia | Canada | V3R 6A7 |
| 46 | Enverus Medical Research | Surrey | British Columbia | Canada | V3V 0C6 |
| 47 | Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | Canada | R3M 3Z4 |
| 48 | SKiN Centre for Dermatology | Peterborough | Ontario | Canada | K9J 5K2 |
| 49 | International Dermatology Research | Montreal | Quebec | Canada | H3H1V4 |
| 50 | Klinikum der Johann Wolfgang Goethe-Universität Frankfurt | Frankfurt am Main | Hessen | Germany | 60590 |
| 51 | Elbe Klinikum Buxtehude | Buxtehude | Lower Saxony | Germany | 21614 |
| 52 | Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer | Dresden | Saxony | Germany | 01307 |
| 53 | Praxis für Ganzheitliche Dermatologie im Ärztehaus | Berlin | Germany | 13055 | |
| 54 | TFS Trial Form Support GmbH | Hamburg | Germany | 20537 | |
| 55 | DermMEDICA Sp. z o.o. | Wroclaw | Dolnoslaskie | Poland | 51-318 |
| 56 | Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O. | Tarnow | Malopolska | Poland | 33100 |
| 57 | Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii | Rzeszow | Podkarpackie | Poland | 35-055 |
| 58 | COPERNICUS Podmiot Leczniczy sp. z o.o. | Gdansk | Pomorskie | Poland | 80-219 |
| 59 | Labderm s.c. | Ossy | Slaskie | Poland | 42-624 |
| 60 | Gabinet Dermatlogiczny. Beata Krecisz | Kielce | Swietokrzyskie | Poland | 25-155 |
| 61 | Clinica Vitae Sp. z o.o. | Gdansk | Woj. Pomorskie | Poland | 80-405 |
| 62 | Clinical Research Group Sp. z o.o. | Warszawa | Poland | 01-142 | |
| 63 | Centralny Szpital Kliniczny MSWiA | Warszawa | Poland | 02-507 |
Sponsors and Collaborators
- Eli Lilly and Company
- Dermira, Inc.
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04250337
Other Study ID Numbers:
- 17803
- 2019-004300-34
- J2T-DM-KGAD
- DRM06-AD06
First Posted:
Jan 31, 2020
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A participant is considered to have completed the study if he/she has completed the last scheduled visit: For participants continuing into Long-term Extension (LTE), upon completion of week 16 visit and rolling into LTE study For participants not continuing into LTE, when participant had either week 16 or Early Termination (ET) visit, and safety follow up visit (12 weeks after last study drug administration) |
| Arm/Group Title | Placebo + Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. Topical Corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response | 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Period Title: Overall Study | ||
| STARTED | 75 | 153 |
| Received at Least One Dose of Study Drug | 75 | 153 |
| COMPLETED | 67 | 142 |
| NOT COMPLETED | 8 | 11 |
Baseline Characteristics
| Arm/Group Title | Placebo + Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid | Total |
|---|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response | Total of all reporting groups |
| Overall Participants | 75 | 153 | 228 |
| Age, Customized (Count of Participants) | |||
| 12 - <18 |
18
24%
|
35
22.9%
|
53
23.2%
|
| >= 18 - <65 |
52
69.3%
|
103
67.3%
|
155
68%
|
| >=65 - <75 |
5
6.7%
|
10
6.5%
|
15
6.6%
|
| >=75 |
0
0%
|
5
3.3%
|
5
2.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
37
49.3%
|
75
49%
|
112
49.1%
|
| Male |
38
50.7%
|
78
51%
|
116
50.9%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
2.7%
|
5
3.3%
|
7
3.1%
|
| Asian |
13
17.3%
|
18
11.8%
|
31
13.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
3
2%
|
3
1.3%
|
| Black or African American |
9
12%
|
21
13.7%
|
30
13.2%
|
| White |
49
65.3%
|
96
62.7%
|
145
63.6%
|
| More than one race |
1
1.3%
|
8
5.2%
|
9
3.9%
|
| Unknown or Not Reported |
1
1.3%
|
2
1.3%
|
3
1.3%
|
| Region of Enrollment (Count of Participants) | |||
| Canada |
8
10.7%
|
14
9.2%
|
22
9.6%
|
| United States |
57
76%
|
111
72.5%
|
168
73.7%
|
| Poland |
8
10.7%
|
19
12.4%
|
27
11.8%
|
| Germany |
2
2.7%
|
9
5.9%
|
11
4.8%
|
Outcome Measures
| Title | Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16. |
|---|---|
| Description | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to Good Clinical Practice (GCP) issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 145 |
| Number (95% Confidence Interval) [percentage of participants] |
22.1
29.5%
|
41.2
26.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 18.3 | |
| Confidence Interval |
(2-Sided) 95% 5.1 to 31.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16 |
|---|---|
| Description | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 145 |
| Number (95% Confidence Interval) [percentage of participants] |
42.2
56.3%
|
69.5
45.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 26.4 | |
| Confidence Interval |
(2-Sided) 95% 12.1 to 40.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16 |
|---|---|
| Description | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 145 |
| Number (95% Confidence Interval) [percentage of participants] |
21.7
28.9%
|
41.2
26.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 18.9 | |
| Confidence Interval |
(2-Sided) 95% 6.1 to 31.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
|---|---|
| Description | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 63 | 139 |
| Least Squares Mean (Standard Error) [Percent change] |
-35.47
(6.358)
|
-50.68
(4.546)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017263 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -15.21 | |
| Confidence Interval |
(2-Sided) 95% -27.7 to -2.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.373 |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16 |
|---|---|
| Description | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 57 | 130 |
| Number (95% Confidence Interval) [percentage of participants] |
31.9
42.5%
|
50.6
33.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 19.2 | |
| Confidence Interval |
(2-Sided) 95% 4.3 to 34.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16 |
|---|---|
| Description | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 53 | 124 |
| Number (95% Confidence Interval) [percentage of participants] |
26.4
35.2%
|
46.8
30.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 21.6 | |
| Confidence Interval |
(2-Sided) 95% 7.1 to 36.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in EASI Score From Baseline at Week 16 |
|---|---|
| Description | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 145 |
| Least Squares Mean (Standard Error) [Percent Change] |
-53.12
(5.097)
|
-76.76
(4.119)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -23.64 | |
| Confidence Interval |
(2-Sided) 95% -33.6 to -13.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.074 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Week 16 in Percent Body Surface Area (BSA) |
|---|---|
| Description | The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. The mixed model repeated measure (MMRM) include treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 53 | 130 |
| Least Squares Mean (Standard Error) [score on a scale] |
16.92
(2.287)
|
-29.19
(1.686)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -12.28 | |
| Confidence Interval |
(2-Sided) 95% -17.07 to -7.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.428 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving EASI-90 at Week 4 |
|---|---|
| Description | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. |
| Time Frame | Baseline to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 145 |
| Number (95% Confidence Interval) [percentage of participants] |
7.2
9.6%
|
10.7
7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.454 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 3.5 | |
| Confidence Interval |
(2-Sided) 95% -4.9 to 11.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in Sleep-loss Score From Baseline to Week 16 |
|---|---|
| Description | Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. . |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 62 | 134 |
| Least Squares Mean (Standard Error) [percent change] |
-36.89
(12.217)
|
-57.03
(7.939)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.117607 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Markov Chain Monte Carlo (MCMC) |
| Estimated Value | -20.14 | |
| Confidence Interval |
(2-Sided) 95% -45.4 to 5.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.810 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sleep-loss Score at Week 16 |
|---|---|
| Description | Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 63 | 139 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.80
(0.132)
|
-1.10
(0.102)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.025293 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Markov Chain Monte Carlo (MCMC) |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.6 to -0.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.134 |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
|---|---|
| Description | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Time Frame | Baseline to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 57 | 130 |
| Number (95% Confidence Interval) [percentage of participants] |
9.3
12.4%
|
23.5
15.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 14.2 | |
| Confidence Interval |
(2-Sided) 95% 3.8 to 24.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
|---|---|
| Description | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Time Frame | Baseline to Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 57 | 130 |
| Number (95% Confidence Interval) [percentage of participants] |
7.1
9.5%
|
8.5
5.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.764 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 1.2 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
|---|---|
| Description | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Time Frame | Baseline to Week 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, with baseline Pruritus NRS score of at least 4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 57 | 130 |
| Number (95% Confidence Interval) [percentage of participants] |
1.8
2.4%
|
3.8
2.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.498 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 1.9 | |
| Confidence Interval |
(2-Sided) 95% -2.9 to 6.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
|---|---|
| Description | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Time Frame | Baseline to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 53 | 124 |
| Number (95% Confidence Interval) [percentage of participants] |
7.5
10%
|
23.4
15.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 15.6 | |
| Confidence Interval |
(2-Sided) 95% 5.3 to 25.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
|---|---|
| Description | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Time Frame | Baseline to Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 53 | 124 |
| Number (95% Confidence Interval) [percentage of participants] |
7.5
10%
|
8.9
5.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.818 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% -8.0 to 10.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
|---|---|
| Description | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Time Frame | Baseline to Week 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, with baseline Pruritus NRS score of at least 5, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 53 | 124 |
| Number (95% Confidence Interval) [percentage of participants] |
1.9
2.5%
|
4.0
2.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.499 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 2.0 | |
| Confidence Interval |
(2-Sided) 95% -3.1 to 7.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16 |
|---|---|
| Description | Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score. |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 53 | 131 |
| Least Squares Mean (Standard Error) [Percentage of Days] |
23.88
(4.823)
|
31.17
(3.512)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.155 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 7.29 | |
| Confidence Interval |
(2-Sided) 95% -2.78 to 17.36 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.104 |
|
| Estimation Comments | ||
| Title | Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16 |
|---|---|
| Description | Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant). |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 145 |
| Median (Full Range) [days] |
NA
|
121.0
|
| Title | Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 |
|---|---|
| Description | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the ANCOVA model with treatment group, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing Values were imputed using last observation carried forward (LOCF) method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 65 | 140 |
| Least Squares Mean (Standard Error) [percent change] |
-37.35
(4.415)
|
-55.04
(3.542)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -17.69 | |
| Confidence Interval |
(2-Sided) 95% -26.37 to -9.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.403 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
|---|---|
| Description | The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 51 | 109 |
| Least Squares Mean (Standard Error) [score on a scale] |
-6.46
(1.855)
|
-9.79
(1.815)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -3.33 | |
| Confidence Interval |
(2-Sided) 95% -5.3 to -1.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.014 |
|
| Estimation Comments | ||
| Title | Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points |
|---|---|
| Description | The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 48 | 105 |
| Number (95% Confidence Interval) [percentage of participants] |
58.7
78.3%
|
77.4
50.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 17.2 | |
| Confidence Interval |
(2-Sided) 95% 0.1 to 34.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index |
|---|---|
| Description | The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 66 | 143 |
| Health State Index UK |
0.05
(0.025)
|
0.15
(0.019)
|
| Health State Index US |
0.03
(0.018)
|
0.10
(0.014)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | Health State Index UK | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 0.11 | |
| Confidence Interval |
(2-Sided) 95% 0.06 to 0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.025 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | Health State Index US | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 0.07 | |
| Confidence Interval |
(2-Sided) 95% 0.04 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.018 |
|
| Estimation Comments | ||
| Title | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS) |
|---|---|
| Description | The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 65 | 143 |
| Least Squares Mean (Standard Error) [millimeters (mm)] |
6.51
(2.364)
|
10.13
(1.831)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.131 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 3.62 | |
| Confidence Interval |
(2-Sided) 95% -1.08 to 8.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.386 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 |
|---|---|
| Description | POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 40 | 101 |
| Least Squares Mean (Standard Error) [score on a scale] |
-6.24
(1.038)
|
-10.23
(0.727)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -4.00 | |
| Confidence Interval |
(2-Sided) 95% -6.26 to -1.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.145 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults |
|---|---|
| Description | PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 43 | 101 |
| Least Squares Mean (Standard Error) [score on a scale] |
-1.08
(1.367)
|
-1.88
(1.027)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.571 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -0.80 | |
| Confidence Interval |
(2-Sided) 95% -3.58 to 1.98 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.407 |
|
| Estimation Comments | ||
| Title | Change From Baseline in PROMIS Depression at Week 16 - Adults |
|---|---|
| Description | PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 43 | 101 |
| Least Squares Mean (Standard Error) [score on a scale] |
-1.21
(1.098)
|
-1.38
(0.834)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.882 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -2.40 to 2.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.127 |
|
| Estimation Comments | ||
| Title | Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics |
|---|---|
| Description | PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 13 | 31 |
| Least Squares Mean (Standard Error) [score on a scale] |
-4.92
(2.333)
|
-1.46
(1.732)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.171 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 3.46 | |
| Confidence Interval |
(2-Sided) 95% -1.56 to 8.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.480 |
|
| Estimation Comments | ||
| Title | Change From Baseline in PROMIS Depression at Week 16 - Pediatrics |
|---|---|
| Description | PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed using the LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 13 | 31 |
| Least Squares Mean (Standard Error) [score on a scale] |
-6.43
(2.536)
|
-2.01
(1.916)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.109 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 4.43 | |
| Confidence Interval |
(2-Sided) 95% -1.03 to 9.89 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.697 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma |
|---|---|
| Description | The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. Missing values were imputed with the LOCF method. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 14 | 38 |
| Least Squares Mean (Standard Error) [score on a scale] |
0.12
(0.116)
|
0.13
(0.076)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.922 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.116 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 |
|---|---|
| Description | The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. One investigational site with seventeen participants was excluded from analysis due to GCP issues. |
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14.TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by a single injection 250 mg Lebrikizumab Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Measure Participants | 11 | 24 |
| Least Squares Mean (Standard Error) [score on a scale] |
-4.71
(1.170)
|
-9.33
(0.887)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo +Topical Corticosteroid, Lebrikizumab + Topical Corticosteroid |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference (Final Values) |
| Estimated Value | -4.62 | |
| Confidence Interval |
(2-Sided) 95% -7.22 to -2.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.271 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Baseline up to Week 28 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All randomized participants who received at least 1 dose of study treatment. | |||
| Arm/Group Title | Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid | ||
| Arm/Group Description | Two placebo SC injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo Q2W from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | 500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. | ||
All Cause Mortality |
||||
| Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/75 (0%) | 0/153 (0%) | ||
Serious Adverse Events |
||||
| Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/75 (1.3%) | 2/153 (1.3%) | ||
| Cardiac disorders | ||||
| Sinus node dysfunction | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fall | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo +Topical Corticosteroid | Lebrikizumab + Topical Corticosteroid | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/75 (34.7%) | 66/153 (43.1%) | ||
| Blood and lymphatic system disorders | ||||
| Eosinophilia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Iron deficiency anaemia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Lymphadenopathy | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Lymphocytosis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Neutropenia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Thrombocytopenia | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| Eye disorders | ||||
| Blepharitis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Conjunctival haemorrhage | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Dry eye | 0/75 (0%) | 0 | 3/153 (2%) | 3 |
| Eye irritation | 0/75 (0%) | 0 | 1/153 (0.7%) | 2 |
| Lacrimation increased | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Vernal keratoconjunctivitis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Xerophthalmia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Flatulence | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Gastrointestinal inflammation | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Nausea | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| Vomiting | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| General disorders | ||||
| Injection site erythema | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Injection site pruritus | 0/75 (0%) | 0 | 1/153 (0.7%) | 2 |
| Injection site rash | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| Injection site reaction | 1/75 (1.3%) | 1 | 2/153 (1.3%) | 2 |
| Injection site swelling | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Vaccination site pain | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Hepatic steatosis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Hepatomegaly | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Immune system disorders | ||||
| Drug hypersensitivity | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Infections and infestations | ||||
| Bacteraemia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Bacterial colitis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Bronchitis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Cellulitis | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Conjunctivitis | 0/75 (0%) | 0 | 7/153 (4.6%) | 8 |
| Covid-19 | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| Furuncle | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Herpes zoster | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| Impetigo | 1/75 (1.3%) | 1 | 2/153 (1.3%) | 2 |
| Nasopharyngitis | 5/75 (6.7%) | 6 | 3/153 (2%) | 5 |
| Ophthalmic herpes simplex | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Oral herpes | 1/75 (1.3%) | 1 | 2/153 (1.3%) | 2 |
| Tonsillitis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Tooth abscess | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Tooth infection | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Upper respiratory tract infection | 2/75 (2.7%) | 2 | 1/153 (0.7%) | 1 |
| Urinary tract infection | 0/75 (0%) | 0 | 3/153 (2%) | 3 |
| Injury, poisoning and procedural complications | ||||
| Concussion | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Corneal abrasion | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Fall | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Fibula fracture | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Ligament sprain | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Limb injury | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Muscle strain | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Suture related complication | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Vaccination complication | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Investigations | ||||
| Alanine aminotransferase increased | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Aspartate aminotransferase increased | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Blood alkaline phosphatase increased | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Blood pressure increased | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 2 |
| Gamma-glutamyltransferase increased | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Weight increased | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Metabolism and nutrition disorders | ||||
| Alcohol intolerance | 0/75 (0%) | 0 | 1/153 (0.7%) | 2 |
| Hypercholesterolaemia | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Hyperglycaemia | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Hyperkalaemia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Hypokalaemia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Malnutrition | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Type 2 diabetes mellitus | 0/75 (0%) | 0 | 2/153 (1.3%) | 2 |
| Vitamin d deficiency | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Bursitis | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Myalgia | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Spinal pain | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Keratoacanthoma | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Nervous system disorders | ||||
| Cervical radiculopathy | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Dizziness | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Headache | 1/75 (1.3%) | 1 | 7/153 (4.6%) | 7 |
| Ophthalmic migraine | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Syncope | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Psychiatric disorders | ||||
| Attention deficit hyperactivity disorder | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Insomnia | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Chronic obstructive pulmonary disease | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Rhinitis allergic | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Rhinorrhoea | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Sinus congestion | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Alopecia areata | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Dermatitis | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Dermatitis acneiform | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Dermatitis atopic | 3/75 (4%) | 3 | 3/153 (2%) | 3 |
| Dermatitis contact | 0/75 (0%) | 0 | 1/153 (0.7%) | 1 |
| Eczema | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Hyperhidrosis | 1/75 (1.3%) | 1 | 0/153 (0%) | 0 |
| Skin lesion inflammation | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 1 |
| Urticaria | 1/75 (1.3%) | 1 | 1/153 (0.7%) | 2 |
| Vascular disorders | ||||
| Hypertension | 1/75 (1.3%) | 1 | 4/153 (2.6%) | 4 |
Limitations/Caveats
One investigational site with seventeen participants was excluded from analysis due to GCP issues.
Because of an error in the electronic data collection tool, the actual maximum score for each of the SCORAD symptoms was 9 instead of 10, resulting in a total maximum SCORAD score of 101 instead of 103. During the study, discussions with the SCORAD copyright owner resulted in a decision not to adjust the scale used or notify investigators as the altered scale was not expected to bias the results.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
| ClinicalTrials.gov@lilly.com |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04250337
Other Study ID Numbers:
- 17803
- 2019-004300-34
- J2T-DM-KGAD
- DRM06-AD06
First Posted:
Jan 31, 2020
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022