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NCT06388941 · ClinicalTrials.gov registry record · Phase 2
Iptacopan in Patients With ANCA Associated Vasculitis
A Phase 2 study of Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT06388941: Active Phase 2 study of Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis, sponsored by Novartis Pharmaceuticals.
NCT06388941 is a Phase 2 study of Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06388941, a Phase 2 study of Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL.
Primary Outcome
To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Iptacopan
Study Locations (20)
Quebec
- Novartis Investigative Site - Fleurimont
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Québec
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Vienna
Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - La Plata
New South Wales
- Novartis Investigative Site - Concord
- Novartis Investigative Site - Westmead
Arizona
- Arizona Arthritis and Rheumatology Research PLLC - Mesa
Minnesota
- Mayo Clinic Rochester - Rochester
New York
- Northwell Health - New York
South Australia
- Novartis Investigative Site - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-08-05 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
What the registry record for NCT06388941 still lists
NCT06388941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06388941 names 20 study sites across 13 states, led by Quebec, Other, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT06388941 about?
NCT06388941 is a clinical study titled "Iptacopan in Patients With ANCA Associated Vasculitis". The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) ...
What is the current status of trial NCT06388941?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2024-08-05. Estimated completion is 2026-12-30.
What conditions does trial NCT06388941 study?
This clinical trial studies the following conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis.
What interventions are being tested in trial NCT06388941?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Iptacopan (DRUG).
Who is sponsoring clinical trial NCT06388941?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06388941 being conducted?
This trial has 20 study locations across Arizona, Minnesota, New York, Buenos Aires, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06388941's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 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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