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NCT05767034 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
NCT05767034: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT05767034 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 381 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05767034, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
Primary Outcome
Sustained remission at Week 52 is defined as a participant meeting all of the following: ● achieved remission at Week 12 AND all of the following, sustained from Week 12 to Week 52: * no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment * no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment Remission at Week 12 is defined as a participant meeting all of the following at Week 12: * no use of
Interventions
- DRUG Secukinumab 300 mg
- DRUG Secukinumab 150 mg
- OTHER Placebo to secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2026-02-16 |
| Phase | Phase 3 |
What the finished NCT05767034 record still lists
NCT05767034 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which Secukinumab 300 mg is the first listed.
NCT05767034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05767034 about?
NCT05767034 is a clinical study titled "Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)". The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
What is the current status of trial NCT05767034?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2023-03-22. Estimated completion is 2026-02-16.
What interventions are being tested in trial NCT05767034?
The interventions under investigation include: Secukinumab 300 mg (DRUG), Secukinumab 150 mg (DRUG), Placebo to secukinumab (OTHER).
Who is sponsoring clinical trial NCT05767034?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05767034's enrollment target sits among peer trials
381 982nd of 2000 higher than 1,018 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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