A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis
1 other identifier
interventional
55
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2015
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
July 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2016
CompletedJanuary 27, 2020
January 1, 2020
10 months
June 4, 2015
January 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-emergent adverse events (TEAEs)
From baseline to week 12
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Group 1: Lebrikizumab Dose Level 1 Monotherapy
EXPERIMENTALDuring 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.
Group 2: Topical Corticosteroid Creams Only
ACTIVE COMPARATORDuring 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.
Interventions
Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
T. Joseph Raoof Md, Inc.
Encino, California, 91436, United States
Allergy and Asthma Relief Experts
Granada Hills, California, 91344, United States
Allergy and Asthma Associates of Southern California - CRN
Mission Viejo, California, 92691, United States
Forward Clinical Trials
Tampa, Florida, 33624, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40241, United States
Respiratory Medicine Research; Institue of Michigan P.L.C.
Ypsilanti, Michigan, 48197, United States
Sadick Research Group
New York, New York, 10075, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick, Rhode Island, 02865, United States
Center for Clinical Studies
Cypress, Texas, 77433, United States
Dr. Lorne E. Albrecht Inc.
Surrey, British Columbia, V3R 6A7, Canada
Skin Care Centre
Vancouver, British Columbia, V5Z 4E8, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Guenther Research Inc.
London, Ontario, N6A 3H7, Canada
The Centre for Clinical Trials Inc.
Oakville, Ontario, L6J 7W5, Canada
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 8, 2015
Study Start
July 30, 2015
Primary Completion
May 30, 2016
Study Completion
May 30, 2016
Last Updated
January 27, 2020
Record last verified: 2020-01