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Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Sponsor
Galderma R&D (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04921345
Collaborator
(none)
70
Enrollment
31
Locations
2
Arms
48.2
Anticipated Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date :
Jun 24, 2021
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: Participants aged 7-11 years

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Drug: Nemolizumab
Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.
Other Names:
  • CD14152

    		•
    Experimental: Cohort 2: Participants aged 2-6 years

    Participants aged 2-6 years will receive nemolizumab for 52 weeks.

    Drug: Nemolizumab
    Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.
    Other Names:
  • CD14152

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nemolizumab Serum Concentrations of Pediatric Participants [At Week 4, 8, 12, 16, 32 and 52]

    2. Apparent Total Body Clearance (Cl/F) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    3. Apparent Volume of Distribution (Vd/F) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    4. Absorption Rate Constant (Ka) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    5. Maximum Observed Serum Concentration (Cmax) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    6. Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    7. Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    8. Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    9. Apparent Terminal Half-life (t1/2) of Nemolizumab [At Week 4, 8, 12, 16, 32 and 52]

    Secondary Outcome Measures

    1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.

    2. Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.

    3. Number of Participants Achieving 50%, 75% or 90% Response From Baseline in Eczema Area and Severity Index (EASI-50, EASI-75 and EASI-90) at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved >=50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.

    4. Investigator's Global Assessment (IGA) Success Rate at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).

    5. Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

    6. Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

    7. Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

    8. Proportion of Participants With an Improvement of >= 4 From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

    9. Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

    10. Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

    11. Absolute Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.

    12. Percent Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.

    13. Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Each Visit up to Week 52 [Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52]

      SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

    14. Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age up to Week 16 and Week 52 [Baseline, Week 16 and Week 52]

      The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).

    15. Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) For Participants <4 Years of Age From Baseline up to Week 16 and up to Week 52 [Baseline, Week 16 and Week 52]

      The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).

    16. Change From Baseline in Patient-Oriented Eczema Measure (POEM) up to Week 16 and Week 52 [Baseline, Week 16 and Week 52]

      The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).

    17. Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Peak Pruritus Numeric Rating Scale (PP NRS) [Baseline, Week 16 and Week 52]

      The relationship between nemolizumab serum concentrations will be evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in PP-NRS score.

    18. Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Eczema Area and Severity Index (EASI) Score [Baseline, Week 16 and Week 52]

      The relationship between nemolizumab serum concentrations will be evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in EASI score.

    19. Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Investigator's Global Assessment (IGA) Score [Baseline, Week 16 and Week 52]

      The relationship between nemolizumab serum concentrations will be evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in IGA score.

    20. Number of Participants with Positive Anti-Drug Antibody (ADA) for Nemolizumab [Baseline, Week 16 and Week 52]

    21. Number of Participants With Adverse Events (AEs), Including Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI), AEs Leading to Discontinuation and Serious Adverse Events (SAEs) [Baseline through week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit

    • EASI score >=16 at both screening and baseline visits

    • IGA score >=3 at both screening and baseline visits

    • AD involvement >=10% of BSA at both screening and baseline visits

    • Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits

    • Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator

    • Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol

    • Other protocol defined inclusion criteria could apply

    Exclusion Criteria:

    • Body weight less than 10 kilogram (kg)

    • Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation

    • Participants with a current medical history of chronic bronchitis

    • Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit

    • Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction [PCR]), or human immunodeficiency virus (HIV) antibody at the screening visit

    • History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids

    • Known or suspected immunosuppression

    • Participants unwilling to refrain from using prohibited medications during the clinical trial.

    • Other protocol defined exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Galderma Investigational Site #8636 Fountain Valley California United States 92708-3701
    2 Galderma Investigational Site #9937 San Diego California United States 92123-2746
    3 Galderma Investigational Site #9930 Vista California United States 92083-6031
    4 Galderma Investigational Site #9929 Coral Gables Florida United States 92083-6031
    5 Galderma Investigational Site #8142 Indianapolis Indiana United States 46250-2041
    6 Galderma Investigational Site #8092 Louisville Kentucky United States 40217-1444
    7 Galderma Investigational Site #8155 Troy Michigan United States 48084-5260
    8 Galderma Investigational Site #8560 West Bloomfield Michigan United States 48322
    9 Galderma Investigational Site #8242 Brooklyn New York United States 11203-2012
    10 Galderma Investigational Site #9938 New York New York United States 10032-3729
    11 Galderma Investigational Site #8206 Norman Oklahoma United States 73069-6301
    12 Galderma Investigational Site #8255 Philadelphia Pennsylvania United States 19103-4708
    13 Galderma Investigational Site #9931 Beaumont Texas United States 77706-3061
    14 Galderma Investigational Site #78218-3128 San Antonio Texas United States 78218-3128
    15 Galderma Investigational Site #6218 Hellerup Denmark 2900
    16 Galderma Investigational Site #5434 Dresden Germany 1307
    17 Galderma Investigational Site #6040 Hamburg Germany 22391
    18 Galderma Investigational Site #5437 Kiel Germany 24105
    19 Galderma Investigational Site #5382 Muenchen Germany 80337
    20 Galderma Investigational Site #5307 Muenster Germany 48149
    21 Galderma Investigational Site #6147 Budapest Hungary 1036
    22 Galderma Investigational Site #5531 Szeged Hungary 6720
    23 Galderma Investigational Site #6145 Bologna Italy 40138
    24 Galderma Investigational Site #5894 Padova Italy 35128
    25 Galderma Investigational Site #6175 Vicenza Italy 36100
    26 Galderma Investigational Site #6237 Ostrowiec Świętokrzyski Poland 27-400
    27 Galderma Investigational Site #5495 Rzeszów Poland 35-055
    28 Galderma Investigational Site #6262 Warszawa Poland 02-953
    29 Galderma Investigational Site #6261 Wrocław Poland 51-685
    30 Galderma Investigational Site #5570 Łódź Poland 90-265
    31 Galderma Investigational Site #5896 Esplugues De Llobregat Spain 0850

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT04921345
    Other Study ID Numbers:
    • RD.06.SPR.118126
    First Posted:
    Jun 10, 2021
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Galderma R&D
    Atopic Dermatitis
    Nemolizumab
    CD14152
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Jul 22, 2022