A Study In Adults With Moderate To Severe Dermatomyositis

Summary

A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis

Timeline

Start

2018-01-23

Primary completion

2022-05-27

Completion

2022-11-28

Outcome

Met primary endpoint

registry (Stage 1) Placebo vs PF-06823859 600 mg IV (Stage 1); p <0.0001; Mean Difference (Final Values) -14.82 (90% CI -20.26 to -9.37); LANCOVA-P model NCT03181893 ↗

Publications

• Aggarwal R, Peeva E, Fiorentino DF, Vleugels RA, Mangold AR, Werth VP, Oemar BS, Rath JN, Sloan A, Chu M. Rapid Onset of Response in Adults with Dermatomyositis Receiving Dazukibart: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study. Clin Cosmet Investig Dermatol. 2026 Jun 4;19:581733. doi: 10.2147/CCID.S581733. eCollection 2026.
• Prybylski JP, Zhu J', Banfield C, Mukherjee A, Purohit V. Early exposure-response modeling of an interferon-beta monoclonal antibody (dazukibart) in adults with dermatomyositis. J Pharmacokinet Pharmacodyn. 2026 Mar 24;53(3):17. doi: 10.1007/s10928-026-10022-1.
• Fiorentino D, Mangold AR, Werth VP, Christopher-Stine L, Femia A, Chu M, Musiek ACM, Sluzevich JC, Graham LV, Fernandez AP, Aggarwal R, Rieger K, Page KM, Li X, Hyde C, Rath N, Sloan A, Oemar B, Banerjee A, Salganik M, Banfield C, Neelakantan S, Beebe JS, Vincent MS, Peeva E, Vleugels RA. Efficacy, safety, and target engagement of dazukibart, an IFNbeta specific monoclonal antibody, in adults with dermatomyositis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2025 Jan 11;405(10473):137-146. doi: 10.1016/S0140-6736(24)02071-3.

Drugs

Indications