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NCT05755386 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
A Phase 3 study of IC-MPGN, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT05755386: Recruiting Phase 3 study of IC-MPGN, sponsored by Novartis Pharmaceuticals.
NCT05755386 is a Phase 3 study of IC-MPGN that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 106 participants, above the 53-participant average among 3 other IC-MPGN trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05755386, a Phase 3 study of IC-MPGN, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
Primary Outcome
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG iptacopan
Study Locations (20)
California
- Ronald Reagan UCLA Medical Center - Los Angeles
- Univ Cali Irvine ALS Neuromuscular - Orange
- UCSF - San Francisco
- Olive View UCLA Medical Center - Sylmar
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Univ School of Medicine - Boston
Texas
- Prolato Clinical Research Center - Houston
- Baylor Scott and White Research - Temple
Colorado
- Childrens Hospital Colorado - Aurora
Florida
- Nicklaus Childrens Hospital - Miami
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Washington University in St Louis - St Louis
New Mexico
- University of New Mexico - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 3 |
What NCT05755386 shows while recruiting
NCT05755386 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 3 other IC-MPGN trials with a reported enrollment target (100% higher).
The record links to 1 condition, with IC-MPGN appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05755386 names 20 study sites across 15 states, led by California, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT05755386 about?
NCT05755386 is a clinical study titled "Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN". This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
What is the current status of trial NCT05755386?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2023-10-02. Estimated completion is 2029-05-31.
What conditions does trial NCT05755386 study?
This clinical trial studies the following conditions: IC-MPGN.
What interventions are being tested in trial NCT05755386?
The interventions under investigation include: Placebo (DRUG), iptacopan (DRUG).
Who is sponsoring clinical trial NCT05755386?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05755386 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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