drugset / Trial / NCT05061771

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

NCT05061771 ↗

Phase 3 Withdrawn AKARI Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-05-06
Primary completion
2022-08-01
Completion
2022-08-01

Outcome

Outcome not reported

Stopped (Business): “Akari has decided to discontinue AK802 study due to strategic resource allocation decisions.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Coversin Protein / enzyme biologic 15 mg Subcutaneous
Comparator Coversin Protein / enzyme biologic 45 mg Subcutaneous

Indications