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NCT07286214 · ClinicalTrials.gov registry record · Phase 4
Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
A Phase 4 study, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
NCT07286214: Recruiting Phase 4 study, sponsored by Sanofi.
NCT07286214 is a Phase 4 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 300 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07286214, a Phase 4 study, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens. The study will consist of the following visits: Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
Primary Outcome
No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).
Interventions
- DRUG Placebo
- DRUG Sarilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-05-12 |
| Est. Completion | 2029-07-16 |
| Phase | Phase 4 |
What NCT07286214 shows while recruiting
NCT07286214 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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07286214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07286214 about?
NCT07286214 is a clinical study titled "Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica". This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone t...
What is the current status of trial NCT07286214?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2026-05-12. Estimated completion is 2029-07-16.
What interventions are being tested in trial NCT07286214?
The interventions under investigation include: Placebo (DRUG), Sarilumab (DRUG).
Who is sponsoring clinical trial NCT07286214?
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 NCT07286214's enrollment target sits among peer trials
300 269th of 2000 higher than 1,709 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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