A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

Summary

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.

Timeline

Start

2016-06-02

Primary completion

2018-05-31

Completion

2018-11-19

Outcome

Missed primary endpoint

registry p =0.0727; MCP-Mod; NCT02804763 ↗

Publications

• Acharya C, Magnusson MO, Vajjah P, Oliver R, Zamacona M. Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus. J Clin Pharmacol. 2023 Apr;63(4):435-444. doi: 10.1002/jcph.2188. Epub 2023 Jan 9.
• Morel T, Cano S, Bartlett SJ, Gordon C, Haier B, Regnault A, Schneider M, Stach C, Cleanthous S. The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus. Rheumatology (Oxford). 2022 Aug 3;61(8):3329-3340. doi: 10.1093/rheumatology/keab920.

Drugs

Indications