drugset / Trial / NCT03443024
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
Timeline
- Start
- 2018-01-30
- Primary completion
- 2019-02-07
- Completion
- 2019-05-23
Outcome
Met primary endpoint
paper lebrikizumab groups showed dose-dependent, statistically significant improvement in the primary end point vs placebo at week 16: PMID 32101256 ↗
registry analysis (superiority test); 125 mg Lebrikizumab (Q4W) vs Placebo; p = 0.0165; ANCOVA NCT03443024 ↗
registry analysis (superiority test); 250 mg Lebrikizumab (Q4W) vs Placebo; p = 0.0022; ANCOVA NCT03443024 ↗
registry analysis (superiority test); 250 mg Lebrikizumab (Q2W) vs Placebo; p = 0.0005; ANCOVA NCT03443024 ↗
Publications
- Rams A, Baldasaro J, Bunod L, Delbecque L, Strzok S, Meunier J, ElMaraghy H, Sun L, Pierce E. Assessing Itch Severity: Content Validity and Psychometric Properties of a Patient-Reported Pruritus Numeric Rating Scale in Atopic Dermatitis. Adv Ther. 2024 Apr;41(4):1512-1525. doi: 10.1007/s12325-024-02802-3. Epub 2024 Feb 16.
- Guttman-Yassky E, Blauvelt A, Eichenfield LF, Paller AS, Armstrong AW, Drew J, Gopalan R, Simpson EL. Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial. JAMA Dermatol. 2020 Apr 1;156(4):411-420. doi: 10.1001/jamadermatol.2020.0079.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lebrikizumab | Monoclonal antibody | 125 mg | Subcutaneous |
| Subject | Lebrikizumab | Monoclonal antibody | 250 mg | Subcutaneous |