NCT04035733

rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

Completed Phase 2 Last updated 22 April 2025

What this trial tests

Phase 2 trial testing rVA576 in Bullous Pemphigoid (BP) in 9 participants. Completed in 29 April 2020.

Timeline

25 September 2018

Primary endpoint
12 March 2020

29 April 2020

Quick facts

Lead sponsor	AKARI Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	25 September 2018
Primary completion	12 March 2020
Estimated completion	29 April 2020
Sites	2 locations across Netherlands, Germany

Drugs / interventions tested

• rVA576 — full drug profile →

Conditions studied

• Bullous Pemphigoid (BP) — all drugs for Bullous Pemphigoid (BP) →

Sponsor

AKARI Therapeutics — full company profile →

Who can join

18 and older, any sex, with Bullous Pemphigoid (BP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pemphigus and Pemphigoid: From Disease Mechanisms to Druggable Pathways.
   Ellebrecht CT, Maseda D, Payne AS. · · 2022 · cited 38× · PMID 34756581 · DOI 10.1016/j.jid.2021.04.040
2. Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update.
   Karakioulaki M, Eyerich K, Patsatsi A. · · 2024 · cited 35× · PMID 38157140 · DOI 10.1007/s40257-023-00832-1
3. Evaluation of Nomacopan for Treatment of Bullous Pemphigoid: A Phase 2a Nonrandomized Controlled Trial.
   Sadik CD, Rashid H, Hammers CM, Diercks GFH, et al · · 2022 · cited 33× · PMID 35507334 · DOI 10.1001/jamadermatol.2022.1156
4. Treatment of Rare Inflammatory Kidney Diseases: Drugs Targeting the Terminal Complement Pathway.
   Anliker-Ort M, Dingemanse J, van den Anker J, Kaufmann P. · · 2020 · cited 33× · PMID 33362783 · DOI 10.3389/fimmu.2020.599417
5. Emerging Role of C5 Complement Pathway in Peripheral Neuropathies: Current Treatments and Future Perspectives.
   Giorgio C, Zippoli M, Cocchiaro P, Castelli V, et al · · 2021 · cited 29× · PMID 33917266 · DOI 10.3390/biomedicines9040399
6. A blistering new era for bullous pemphigoid: A scoping review of current therapies, ongoing clinical trials, and future directions.
   Khalid SN, Khan ZA, Ali MH, Almas T, et al · · 2021 · cited 17× · PMID 34540212 · DOI 10.1016/j.amsu.2021.102799
7. Dupilumab effectively and rapidly treats bullous pemphigoid by inhibiting the activities of multiple cell types.
   Yan T, Xie Y, Liu Y, Shan Y, et al · · 2023 · cited 16× · PMID 37575240 · DOI 10.3389/fimmu.2023.1194088
8. Bullous Pemphygoid and Novel Therapeutic Approaches.
   D'Agostino GM, Rizzetto G, Marani A, Marasca S, et al · · 2022 · cited 11× · PMID 36359364 · DOI 10.3390/biomedicines10112844