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NCT03713619 · ClinicalTrials.gov registry record · Phase 3
This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 544
- Enrollment target
NCT03713619: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03713619 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 544 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03713619, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 544 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study also assessed the safety and tolerability of secukinumab.
Primary Outcome
HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logis
Interventions
- DRUG Placebo
- DRUG secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2022-07-26 |
| Phase | Phase 3 |
What the finished NCT03713619 record still lists
NCT03713619 is an interventional study that assigns participants to a tested intervention. The registered 544 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 (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03713619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03713619 about?
NCT03713619 is a clinical study titled "This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).". The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study also ass...
What is the current status of trial NCT03713619?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2019-01-31. Estimated completion is 2022-07-26.
What interventions are being tested in trial NCT03713619?
The interventions under investigation include: Placebo (DRUG), secukinumab (DRUG).
Who is sponsoring clinical trial NCT03713619?
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 NCT03713619's enrollment target sits among peer trials
544 691st of 2000 higher than 1,307 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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