Trials / Completed
CompletedNCT05149313
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine
A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (actual)
- Sponsor
- Almirall, S.A. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Lebrikizumab | Lebrikizumab solution for injection administered subcutaneously. |
| DRUG | Lebrikizumab-matching Placebo | Matching Placebo solution for injection administered subcutaneously. |
Timeline
- Start date
- 2021-12-23
- Primary completion
- 2023-01-30
- Completion
- 2024-05-07
- First posted
- 2021-12-08
- Last updated
- 2025-05-20
- Results posted
- 2024-11-06
Locations
48 sites across 8 countries: Austria, Belgium, France, Germany, Netherlands, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05149313. Inclusion in this directory is not an endorsement.