Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Iptacopan in Patients With ANCA Associated Vasculitis
NCT06388941 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06388941 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Quebec, Other, Buenos Aires. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06388941?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Iptacopan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06388941?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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 Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.