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NCT04520451 · ClinicalTrials.gov registry record · Phase 2
Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
A Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT04520451: Completed Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
NCT04520451 is a Phase 2 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04520451, a Phase 2 study, has completed, sponsored by Principia Biopharma, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib with glucocorticoids and (2) Active Comparator: glucocorticoids only.
Primary Outcome
Disease flare is defined as an increase in IgG4-RD responder index (RI) \>2 or initiation of rescue treatment.
Interventions
- DRUG rilzabrutinib
- DRUG Glucocorticoids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-08-22 |
| Est. Completion | 2024-10-15 |
| Phase | Phase 2 |
What the finished NCT04520451 record still lists
NCT04520451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which rilzabrutinib is the first listed.
NCT04520451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04520451 about?
NCT04520451 is a clinical study titled "Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants". This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib with glucocorticoids and (2) Active Comparator: glucocorticoids only.
What is the current status of trial NCT04520451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2020-08-22. Estimated completion is 2024-10-15.
What interventions are being tested in trial NCT04520451?
The interventions under investigation include: rilzabrutinib (DRUG), Glucocorticoids (DRUG).
Who is sponsoring clinical trial NCT04520451?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04520451's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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