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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 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. The trial reports 20 study locations across 13 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06388941
The ClinicalTrials.gov registry entry for NCT06388941 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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