NCT05061771

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

A Randomized, Part A Partial Blinded and Part B Double Blinded, Placebo-controlled 24-week Clinical Study to Evaluate the Efficacy and Safety of Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AKARI Therapeutics · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
DRUG	nomacopan (rVA576)	Nomacopan an inhibitor of complement C5 and LTB4
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-05-06
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2021-09-30
• Last updated: 2025-04-09

Locations

12 sites across 4 countries: United States, Germany, Netherlands, Poland

Regulatory

• FDA-regulated drug study