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Bullous Pemphigoid (BP)Phase 2NCT04035733

rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

A Phase 2 study testing rVA576 in people with Bullous Pemphigoid (BP), run by AKARI Therapeutics at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bullous pemphigoid (BP) is the most common of the autoimmune blistering skin diseases in Western Europe. [Joly 2012]The study will recruit the new onset or relapsing mild to moderate BP patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bullous Pemphigoid (BP)
What is being tested?
rVA576
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesin 2 countries
Study dates
25 Sep 2018to 29 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female ≥18-year-old patients
  • Subject with newly presenting mild to moderate cutaneous bullous pemphigoid (BP)
  • BPDAI global score at the screening of 10-56 (≥ 10 but <56)
  • Subjects with a relapse of mild to moderate bullous pemphigoid are eligible if their disease was quiescent for at least 2 months before the current relapse.
  • Cutaneous bullous pemphigoid (BP) per standard diagnostic criteria:
  • Clinical presentation (cutaneous blistering and/or itchy dermatosis), AND
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  • Direct immunofluorescence (DIF) studies.
  • Karnofsky performance status ≥ 60%
  • Adequate cardiac, renal, hepatic, neurological and psychiatric function as determined by the Investigator and demonstrated by screening laboratory evaluations, vital sign measurement, ECG recording and physical examination results.
  • Women of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative serum pregnancy test at screening and a negative urine pregnancy test per the schedule of visits.
  • Males with a childbearing potential partner must agree to use effective contraception consistently OR have had a vasectomy
  • Willing and able to adhere to the study visit schedule and other protocol requirements.
  • Willing and able to provide voluntary written informed consent
  • Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with applicable guidelines and local standard of care of the PI at the trial site

Who cannot join

  • Patients with severe BP. Severe disease to defined as global BPDAI ≥ 56.
  • Patients with refractory BP.
  • Suspected drug-induced BP
  • Concomitant skin conditions preventing physical evaluation of BP.
  • Participation in a clinical trial of an investigational product within 6 weeks of screening.
  • Known hypersensitivity to tick or to rVA576 and any of its excipients.
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  • BP patients on systemic corticosteroid or systemic immunomodulator or other treatment for the current BP episode (including azathioprine, dapsone, doxycycline, etc) provided the treatment cannot be discontinued before Day 1.
  • Treatment with biologics (e.g. etanercept, adalimumab, ustekinumab, infliximab, intravenous immunoglobulin (IVIG) and rituximab or other anti-CD20 therapies) within 5 half-lives of the drugs prior to screening.
  • Known hypersensitivity to mometasone furoate or to other corticosteroids or to any excipients in mometasone furoate
  • Received rVA576 for the treatment of the current episode of BP prior to study entry.
  • Patients with severe medical or surgical conditions at screening or Day 1 including, but not limited to cardiac, respiratory, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or any other severe acute or chronic medical condition that may increase the risk associated with study participation/treatment or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for study entry.
  • Presence of any malignancy that has been under active treatment or in previous 5 years except for patients with the removal of uncomplicated basal cell carcinoma or cutaneous squamous cell carcinoma, who may take part in the study.
  • Congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, organ transplantation).
  • Clinically significant vital sign measurements or ECG findings as determined by the Investigator.
  • Clinically significant abnormal laboratory test results.
  • The active or recent history of clinically significant infection within 1 month of Screening.
  • Pregnant or breast-feeding, or planning to become pregnant during the study.
  • Evidence of an active disease of hepatitis B (HBsAg positive or HBcAg positive) or hepatitis C (HCV ab positive), CMV (IgM positive) or human immunodeficiency virus (HIV) infection (HIV1/2 Ab positive)
  • Active abuse of alcohol or drugs.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • University of Lubeck

    Lübeck

Other trials in Germany

Netherlands1 site

  • UMCG Groningen

    Groningen, Hanzeplein 1, 9700 RB

Other trials in Netherlands

About this study

Official title: A Phase IIa Open-label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

Bullous pemphigoid (BP) is the most common of the autoimmune blistering skin diseases in Western Europe. [Joly 2012]The study will recruit the new onset or relapsing mild to moderate BP patients. The study population will consist of patients above the age of 18 years with an active episode of BP, confirmed by inclusion and exclusion criteria and who, in the opinion of the Investigator, would benefit from treatment with rVA576. Recombinant rVA576 is a small protein complement C5 and LTB4 inhibitor, which prevents the cleavage of C5 by C5 convertase and thereby inhibits generation of C5b-9 the membrane attack complex (MAC), as well as preventing the release of the anaphylatoxin C5a. rVA576 is effective in inhibiting terminal complement activity irrespective of the activating pathway (classical, lectin or alternative). This Phase IIa open-label single-arm study will evaluate the safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid patients

Being tested
rVA576
Medical subject headings
Pemphigoid, Bullous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rVA576Drug

    BP subjects will be treated with 30 mg once daily rVA576 regime for 6 weeks.

Study groups in NCT04035733
Study groupRoleWhat they receive
Open-label single arm studyExperimentalNot described
Receives: Drug: rVA576

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety parameter

    Proportion of participants reporting grade 3, 4 and 5 adverse events, which are related/possibly related to rVA576 during the treatment period.

    Treatment emergent adverse events (TEAEs) consist of:

    • Change from baseline in physical examination
    • ECG
    • Clinical laboratory tests
    • Vital signs The Common Terminology Criteria for Adverse Events (CTCAE v4.03) will be used to grade adverse events.

    Measured: 42 days

Secondary outcomes (2)

  1. Efficacy Parameter

    Change in BPDAI between baseline (Day 1) and Day 42.

    Measured: 42 days

  2. Quality of life questionnaire

    Change in quality of life questionnaire between baseline (Day 1) and Day 42

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start25 Sep 2018
  3. Primary completion12 Mar 2020
  4. Study completion29 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A Phase IIa open-label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04035733
Sponsor's protocol ID
AK801
Status last verified
Jun 2021
First submitted
12 Apr 2019
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sadik CD, Rashid H, Hammers CM, Diercks GFH, Weidinger A, Beissert S, Schauer F, Fettiplace J, Thaci D, Ngai Y, Nunn MA, Zillikens D, Horvath B. Evaluation of Nomacopan for Treatment of Bullous Pemphigoid: A Phase 2a Nonrandomized Controlled Trial. JAMA Dermatol. 2022 Jun 1;158(6):641-649. doi: 10.1001/jamadermatol.2022.1156.

    PubMed 35507334

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rVA576 in people with Bullous Pemphigoid (BP), run by AKARI Therapeutics at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety parameter (time frame: 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035733, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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