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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Bullous Pemphigoid

In brief

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.

Key facts

Study ID: NCT05061771
Run by: AKARI Therapeutics
People needed: 0
Starts: 2022-05-06
Expected to finish: 2022-08-01
Last updated by the study team: 2025-04-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female between 18 and 89 years of age inclusive at the time of consent with Karnofsky score of 50% or more at screening
Male or female ≥90 years of age at the time of consent with Karnofsky score of 70% or more at screening
Diagnosis of Bullous Pemphigoid either newly diagnosed or relapsing
Patients with confirmed atypical Bullous Pemphigoid
Bullous Pemphigoid classified as either moderate or severe on the basis of the Investigator Global Assessment (IGA) at randomisation
Willing to receive immunisation against Neisseria meningitidis and/or antibiotic prophylaxis
Provision of voluntary written informed consent

You may not qualify if…

Patients with recalcitrant BP that have never achieved CDA or who have never been in complete disease remission despite long term treatment with super potent topical steroid or oral cotricosteroid
Epidermolysis bullosa acquisita, mucous membrane pemphigoid, or anti p200 pemphigoid
Mucosal lesions BPDAI score accounts for ≥30% of total BPDAI activity score at randomisation
BP considered to be drug induced, in particular diagnosis of BP made within two months of starting a drug well known to induce BP
Treatment with BP-directed biologics including: a) Any cell-depleting agents including, but not limited to, rituximab within 12 months prior to baseline, b) Other biologics within five half-lives (if known) or 16 weeks prior to the baseline, whichever is longer, or c) Intravenous immunoglobulin within 16 weeks prior to the baseline.
Taking > 0.3 mg/kg/day OCS at screening
Treatment with systemic immunomodulators such as dapsone or doxycycline within four half-lives of the drugs prior to baseline Day 1
Treatment with immunosuppressants within the last two weeks prior to baseline
Treatment with an anti-complement therapy or with Zileuton within the last three months prior to baseline
OCS dose no more than 0.3mg/kg/day in the 7 days before screening visit
Taking super-potent topical corticosteroids and unable to discontinue them at or before the screening assessment
Active systemic or organ system bacterial or fungal infection or progressive severe infection
Known congenital immunodeficiency or a history of acquired immunodeficiency including a positive human immunodeficiency virus (HIV) test
Active infection with hepatitis B or C
Positive nasal throat swab for Neisseria species
Known hypersensitivity to nomacopan and any of its excipients
Receipt of live attenuated vaccines within 2 weeks of Day 1

Where it is running

Tulane University Health Sciences Center — Los Angeles, California, United States
North Shore University Health System — Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group LLC — Indianapolis, Indiana, United States
David Fivenson MD PLC — Ann Arbor, Michigan, United States
Duke Dermatology — Durham, North Carolina, United States
Wright State Physicians 725 University Blvd. — Fairborn, Ohio, United States
UMPC Department of Dermatology — Pittsburgh, Pennsylvania, United States
MENSINGDERMA Research GmbH — Hamburg, Germany
Universitätsklinikum Schleswig-Holstein — Kiel, Germany
Universitäts Hautklinik — Tübingen, Germany
University Medical Center Groningen — Groningen, Netherlands
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska — Wroclaw, Poland

Full record on ClinicalTrials.gov

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