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NCT06073093 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 264
- Enrollment target
NCT06073093: Completed Phase 2 study, sponsored by Sanofi.
NCT06073093 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 264 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06073093, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 264 participants
- Enrollment target
Study Summary
This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.
Primary Outcome
ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Quest
Interventions
- DRUG Placebo
- DRUG SAR441566
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2023-11-07 |
| Est. Completion | 2025-07-02 |
| Phase | Phase 2 |
What the finished NCT06073093 record still lists
NCT06073093 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06073093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06073093 about?
NCT06073093 is a clinical study titled "A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis". This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult parti...
What is the current status of trial NCT06073093?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2023-11-07. Estimated completion is 2025-07-02.
What interventions are being tested in trial NCT06073093?
The interventions under investigation include: Placebo (DRUG), SAR441566 (DRUG).
Who is sponsoring clinical trial NCT06073093?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06073093's enrollment target sits among peer trials
264 210th of 2000 higher than 1,791 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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