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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 is a Phase 4 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 300 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07286214
The ClinicalTrials.gov registry entry for NCT07286214 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07286214 reports 0 study locations.
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.
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