Atopic Dermatitis
Conditions
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.
Interventions
DRUGLebrikizumab
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | From baseline to week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with disease rebound following discontinuation of study drug | within 20 weeks |
| Serum lebrikizumab concentration at Week 12 | Week 12 |
| Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies | From baseline to week 20 |
| 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 |
| Elimination half-life | Week 4 |
Countries
Canada, United States
Outcome results
None listed