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NCT05662241 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
A Phase 3 study of IgG4 Related Disease, sponsored by Zenas BioPharma (USA).
- Active
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT05662241: Active Phase 3 study of IgG4 Related Disease, sponsored by Zenas BioPharma (USA).
NCT05662241 is a Phase 3 study of IgG4 Related Disease that is active but no longer recruiting, run by Zenas BioPharma (USA). The registered enrollment target is 194 participants, above the 44-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (341% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05662241, a Phase 3 study of IgG4 Related Disease, is active but no longer recruiting, sponsored by Zenas BioPharma (USA).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
Primary Outcome
Time to first IgG4-RD flare, defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC), from randomization to Week 52.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Obexelimab
Study Locations (20)
Beijing Municipality
- Chinese PLA General Hospital - Beijing
- Peking Union Medical College Hospital - Beijing
- Peking University First Hospital - Beijing
California
- Stanford Medicine - Stanford
Florida
- GI PROS Research - Dedicated Research Facility - Naples
Georgia
- Emory Univeristy - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
Other
- Hospital Italiano de Buenos Aires - Buenos Aires
British Columbia
- Artus Health Centre - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2029-02-15 |
| Phase | Phase 3 |
What the registry record for NCT05662241 still lists
NCT05662241 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 44-participant average among 4 other IgG4 Related Disease trials with a reported enrollment target (341% higher).
The record links to 1 condition, with IgG4 Related Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05662241 names 20 study sites across 18 states, led by Beijing Municipality, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05662241 about?
NCT05662241 is a clinical study titled "A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease". This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
What is the current status of trial NCT05662241?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2023-01-09. Estimated completion is 2029-02-15.
What conditions does trial NCT05662241 study?
This clinical trial studies the following conditions: IgG4 Related Disease.
What interventions are being tested in trial NCT05662241?
The interventions under investigation include: Placebo (OTHER), Obexelimab (DRUG).
Who is sponsoring clinical trial NCT05662241?
This trial is sponsored by Zenas BioPharma (USA), which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05662241 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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