Phase III Trial to Investigate Efficacy and Safety of Vilobelimab
Sponsor
InflaRx GmbH (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05964413
Collaborator
(none)
90
2
33
Study Details
Study Description
Brief Summary
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum
Anticipated Study Start Date
:
Aug 15, 2023
Anticipated Primary Completion Date
:
Feb 13, 2026
Anticipated Study Completion Date
:
May 15, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IFX-1
|
Drug: IFX-1
IFX-1 infusion
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo Infusion
|
Outcome Measures
Primary Outcome Measures
- To evaluate the efficacy of treatment with vilobelimab compared to placebo in patients with PG [Week 1 to Week 26]
Efficacy of Vilobelimab compared to placebo - complete closure of the ulcer
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- clinical diagnosis of ulcerative PG
Exclusion Criteria:
- Women of childbearing potential (WOCBP) who have a positive serum pregnancy test result within 7 days before treatment or are breast feeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- InflaRx GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
InflaRx GmbH
ClinicalTrials.gov Identifier:
NCT05964413
Other Study ID Numbers:
- IFX-1-P3.4
First Posted:
Jul 27, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: