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NCT02059291 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
NCT02059291: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02059291 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 203 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02059291, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
Study Summary
This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.
Primary Outcome
Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) \<2 and C-reactive protein (CRP) within normal range (\<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and sy
Interventions
- DRUG Placebo
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2014-06-27 |
| Est. Completion | 2017-07-04 |
| Phase | Phase 3 |
What the finished NCT02059291 record still lists
NCT02059291 is an interventional study that assigns participants to a tested intervention. The registered 203 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02059291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02059291 about?
NCT02059291 is a clinical study titled "Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers". This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.
What is the current status of trial NCT02059291?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2014-06-27. Estimated completion is 2017-07-04.
What interventions are being tested in trial NCT02059291?
The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG).
Who is sponsoring clinical trial NCT02059291?
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 NCT02059291's enrollment target sits among peer trials
203 1352nd of 2000 higher than 648 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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