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Complement Inhibitor

nomacopan (rVA576) for Bullous Pemphigoid (ARREST-BP Trial)

Phase 3
Waitlist Available
Research Sponsored by AKARI Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 16 - 24
Awards & highlights

ARREST-BP Trial 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.

Eligible Conditions
  • Bullous Pemphigoid

ARREST-BP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 16 - 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 16 - 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of Complete Disease Remission
Secondary outcome measures
Achievement Partial Disease Remission
Adverse Events
Cumulative oral corticosteroid, OCS, during treatment
+7 more

ARREST-BP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: nomacopan (rVA576)Active Control1 Intervention
PART A: High dose nomacopan (standard complement ablating doses on Day 1 followed by 45 mg qd) administered by subcutaneous injection, plus a starting dose of 0.5 mg/kg/day OCS qd or Low dose nomacopan (standard complement ablating doses on Day 1 followed by 15 mg qd) administered by subcutaneous injection, plus a starting dose of 0.5 mg/kg/day OCS PART B: Nomacopan (standard complement ablating doses on Day 1 followed by to be confirmed mg qd) administered by subcutaneous injection, plus a starting dose of 0.5 mg/kg/day OCS qd
Group II: PlaceboPlacebo Group1 Intervention
PART A: Placebo (matching standard complement ablating doses on Day 1 and then matching injection volume of 45mg dose qd) administered by subcutaneous injection, plus a starting dose of 0.5 mg/kg/day oral corticosteroid (OCS) qd or Placebo (matching standard complement ablating doses on Day 1 and then matching injection volume of 15mg dose qd) administered by subcutaneous injection, plus a starting dose of 0.5 mg/kg/day oral corticosteroid (OCS) qd PART B: Placebo (matching standard complement ablating doses on Day 1 and then matching injection volume of active dose qd) administered by subcutaneous injection, plus a starting dose of 0.5 mg/kg/day oral corticosteroid (OCS) qd

Find a Location

Who is running the clinical trial?

AKARI TherapeuticsLead Sponsor
7 Previous Clinical Trials
102 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)
2022. "Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061771.
~0 spots leftby Apr 2025
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