A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

Phase 2 Completed 221 enrolled Celgene Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).

Timeline

Start: 2021-05-14
Primary completion: 2022-07-20
Completion: 2022-11-09

Outcome

Met primary endpoint

paper The primary efficacy end point was met for cendakimab, 720 mg, once weekly vs placebo (-84.4 vs -62.7; P = .003) PMID 39018038 ↗

registry analysis (superiority test); Treatment 1 vs Placebo; p = 0.003; Mean Difference (Final Values) -21.76 (95% CI -35.81 to -7.70); ANCOVA NCT04800315 ↗

Publications

Blauvelt A, Guttman-Yassky E, Lynde C, Khattri S, Schlessinger J, Imafuku S, Tada Y, Morita A, Wiseman M, Kwiek B, Machkova M, Zhang P, Linaberry M, Li J, Zhang S, Franchin G, Charles ED, De Oliveira CHMC, Silverberg JI. Cendakimab in Patients With Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Aug 1;160(8):856-864. doi: 10.1001/jamadermatol.2024.2131.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cendakimab	Monoclonal antibody	360 mg	Subcutaneous
Subject	Cendakimab	Monoclonal antibody	720 mg	Subcutaneous