A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT02465606

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

2.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective for this study is to evaluate the safety of lebrikizumab compared with Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic Dermatitis (AD) that is inadequately controlled with TCS.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Lebrikizumab Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis

Actual Study Start Date :

Jul 30, 2015

Actual Primary Completion Date :

May 30, 2016

Actual Study Completion Date :

May 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Lebrikizumab Dose Level 1 Monotherapy During the 2-week run-in period, participants will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 12-week treatment period, lebrikizumab monotherapy will be administered by subcutaneous (SC) injection, but participants assigned to this group will not receive topical corticosteroids. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.	Drug: Lebrikizumab Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses. Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.
Active Comparator: Group 2: Topical Corticosteroid Creams Only During the 2-week run-in period and during the 12-week treatment period, participants assigned to this group will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.	Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.

Arm

Intervention/Treatment

Experimental: Group 1: Lebrikizumab Dose Level 1 Monotherapy

During the 2-week run-in period, participants will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 12-week treatment period, lebrikizumab monotherapy will be administered by subcutaneous (SC) injection, but participants assigned to this group will not receive topical corticosteroids. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.

Drug: Lebrikizumab

Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.

Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)

Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.

Active Comparator: Group 2: Topical Corticosteroid Creams Only

During the 2-week run-in period and during the 12-week treatment period, participants assigned to this group will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.

Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-emergent adverse events (TEAEs) [From baseline to week 12]

Secondary Outcome Measures

Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies [From baseline to week 20]
Number of participants with disease rebound following discontinuation of study drug [within 20 weeks]
Serum lebrikizumab concentration at Week 12 [Week 12]
Elimination half-life [Week 4]
Number of participants with skin and other organ system infections [From baseline to week 12]
Number of participants with injection site reactions [From baseline to week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 75 years, inclusive, at the start of the run-in period
AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
History of inadequate response to a >/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
EASI score >/= 14 at screening
IGA score >/= 3
AD involvement of >/= 10% body surface area
Pruritus Visual Analog Scale score >/= 3

Exclusion Criteria:

Past and/or current use of any anti-IL-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
Other recent infections meeting protocol criteria
Active tuberculosis requiring treatment within the 12 months prior to Visit 1
Evidence of acute or chronic hepatitis or known liver cirrhosis
Known immunodeficiency, including HIV infection
Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient is willing to stop TCI use during the study (including the run-in period) and, in the investigator's opinion, it is safe to do so
Clinically significant abnormality on screening ECG or laboratory tests
Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	T. Joseph Raoof Md, Inc.	Encino	California	United States	91436
2	Allergy and Asthma Relief Experts	Granada Hills	California	United States	91344
3	Allergy and Asthma Associates of Southern California - CRN	Mission Viejo	California	United States	92691
4	Forward Clinical Trials	Tampa	Florida	United States	33624
5	Dermatology Specialists Research, LLC	Louisville	Kentucky	United States	40241
6	Respiratory Medicine Research; Institue of Michigan P.L.C.	Ypsilanti	Michigan	United States	48197
7	Montefiore Medical Center	Bronx	New York	United States	10467
8	Sadick Research Group	New York	New York	United States	10075
9	Oregon Medical Research Center	Portland	Oregon	United States	97223
10	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
11	Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)	Warwick	Rhode Island	United States	02865
12	Center for Clinical Studies	Cypress	Texas	United States	77433
13	Dr. Lorne E. Albrecht Inc.	Surrey	British Columbia	Canada	V3R 6A7
14	Skin Care Centre	Vancouver	British Columbia	Canada	V5Z 4E8
15	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
16	Guenther Research Inc.	London	Ontario	Canada	N6A 3H7
17	The Centre for Clinical Trials Inc.	Oakville	Ontario	Canada	L6J 7W5
18	York Dermatology Center	Richmond Hill	Ontario	Canada	L4C 9M7
19	K. Papp Clinical Research Inc.	Waterloo	Ontario	Canada	N2J 1C4