Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)

• Status: Not yet recruiting
• Trial end date: 2025-06-01

Summary

A phase III two-part study of nomacopan, a bifunctional inhibitor of complement component C5 and leukotriene B4 (LTB4), for the treatment of moderate and severe bullous pemphigoid. There is evidence that both terminal complement activation (via C5) and the lipid mediator LTB4 may have a central role in driving the disease. In this study patients will be randomized to receive either nomacopan plus oral corticosteroids (OCS) or placebo plus OCS for a treatment period of 24 weeks. OCS will be tapered over the course of the treatment if the symptoms of disease improve.

Part A the 4-arm study in 48 patients will compare two different doses of nomacopan with placebo and is anticipated to complete and report in March 2023.

Part B the confirmatory 2-arm study in approximately 100 patients will compare a single dose of nomacopan with placebo and is anticipated to complete and report in June 2025.

• Phase: Phase 3

Details

• Lead Sponsor: AKARI Therapeutics