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NCT07201129 · ClinicalTrials.gov registry record · Phase 3
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
A Phase 3 study of Lupus Erythematosus, Systemic and Nephritis, Lupus, sponsored by Viatris Innovation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 6
- Study locations
NCT07201129: Recruiting Phase 3 study of Lupus Erythematosus, Systemic and Nephritis, Lupus, sponsored by Viatris Innovation.
NCT07201129 is a Phase 3 study of Lupus Erythematosus, Systemic and Nephritis, Lupus that is actively recruiting participants, run by Viatris Innovation. The registered enrollment target is 300 participants, above the 193-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (55% higher). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07201129, a Phase 3 study of Lupus Erythematosus, Systemic and Nephritis, Lupus, is actively recruiting participants, sponsored by Viatris Innovation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 6
- Study locations
Study Summary
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are: * Does cenerimod improve kidney function in participants? * What medical problems do participants have when taking cenerimod? Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment. Participants will: * Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment. * Visit the clinic every 1 to 3 months for checkups and tests.
Primary Outcome
CRR at Week 76, defined as (both must be met): * Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND * No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cenerimod
Study Locations (6)
Florida
- SouthCoast Research Center - Miami
- Allied Biomedical Research Institute - Miami
- ProfessionalResearchCenter INC - Miami
- San Marcus Research Clinic, Inc. - Miami Lakes
Texas
- Rheumatology Care Center, PLLC - Bellaire
- Northwest Houston Arthritis - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-02-09 |
| Est. Completion | 2030-02 |
| Phase | Phase 3 |
What NCT07201129 shows while recruiting
NCT07201129 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (55% higher).
The record links to 2 conditions, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07201129 lists 6 locations in 2 states (Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT07201129 about?
NCT07201129 is a clinical study titled "A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment". The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are: * Does cen...
What is the current status of trial NCT07201129?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2026-02-09. Estimated completion is 2030-02.
What conditions does trial NCT07201129 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic, Nephritis, Lupus.
What interventions are being tested in trial NCT07201129?
The interventions under investigation include: Placebo (DRUG), Cenerimod (DRUG).
Who is sponsoring clinical trial NCT07201129?
This trial is sponsored by Viatris Innovation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07201129 being conducted?
This trial has 6 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lupus Erythematosus, Systemic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07201129's enrollment target sits among peer trials
300 6th of 29 higher than 24 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic 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
-
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
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A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
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-
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
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A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
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A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
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COMPLETED · Phase 3
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