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NCT03713632 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)
A Phase 3 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 545
- Enrollment target
- 20
- Study locations
NCT03713632: Completed Phase 3 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
NCT03713632 is a Phase 3 study of Hidradenitis Suppurativa that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 545 participants, roughly in line with the 588-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03713632, a Phase 3 study of Hidradenitis Suppurativa, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 545 participants
- Enrollment target
- 20
- Study locations
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 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Secukinumab
Study Locations (20)
Other
- Novartis Investigative Site - Capital Federal
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Liège
California
- Novartis Investigative Site - San Diego
- Novartis Investigative Site - Whittier
Florida
- Novartis Investigative Site - Coral Gables
- Novartis Investigative Site - Tampa
Missouri
- Novartis Investigative Site - St Louis
- Novartis Investigative Site - St Louis
Texas
- Novartis Investigative Site - Bellaire
- Novartis Investigative Site - Pflugerville
Georgia
- Novartis Investigative Site - Sandy Springs
Indiana
- Novartis Investigative Site - Indianapolis
Massachusetts
- Novartis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2019-02-25 |
| Est. Completion | 2022-07-19 |
| Phase | Phase 3 |
What the finished NCT03713632 record still lists
NCT03713632 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 588-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target.
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03713632 names 20 study sites across 14 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03713632 about?
NCT03713632 is a clinical study titled "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 assessed...
What is the current status of trial NCT03713632?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 545 participants. The study started on 2019-02-25. Estimated completion is 2022-07-19.
What conditions does trial NCT03713632 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa.
What interventions are being tested in trial NCT03713632?
The interventions under investigation include: Placebo (DRUG), Secukinumab (DRUG).
Who is sponsoring clinical trial NCT03713632?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03713632 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03713632's enrollment target sits among peer trials
545 13th of 52 higher than 40 of 52 other Hidradenitis Suppurativa trials
participants (enrollment target), bucketed by value
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