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NCT04179175 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
A Phase 3 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 703
- Enrollment target
- 20
- Study locations
NCT04179175: Active Phase 3 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
NCT04179175 is a Phase 3 study of Hidradenitis Suppurativa that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 703 participants, above the 585-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04179175, a Phase 3 study of Hidradenitis Suppurativa, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 703 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).
Primary Outcome
Loss of response was defined as: * at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN. * at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks
Conditions Studied
Interventions
- DRUG secukinumab
Study Locations (20)
Florida
- Florida Academic Centers Research and Education LLC - Coral Gables
- University of MiamiHealth System - Miami
- Olympian Clinical Research - Tampa
- University Of South Florida - Tampa
California
- MedDerm Associates - San Diego
- University Clinical Trials - San Diego
- Southern California Skin and Laser - Whittier
Missouri
- MediSearch Clinical Trials - Saint Joseph
- St Louis U Clinical Trials - St Louis
- WA Uni School Of Med - St Louis
Illinois
- Endeavor Health - Glenview
- Dundee Dermatology - West Dundee
Massachusetts
- Tufts Medical Center - Boston
- Beth Israel Deaconess Med Center - Boston
Arkansas
- Northwest Arkansas Center - Rogers
Georgia
- Advanced Medical Research - Sandy Springs
Indiana
- Dawes Fretzin Clinical Rea Group - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 703 participants |
| Start Date | 2020-03-18 |
| Est. Completion | 2026-07-15 |
| Phase | Phase 3 |
What the registry record for NCT04179175 still lists
NCT04179175 is an interventional study that assigns participants to a tested intervention. The registered 703 participants enrollment target is mid-sized for trials with a published cap, above the 585-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 1 intervention - of which secukinumab is the first listed.
NCT04179175 names 20 study sites across 11 states, led by Florida, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT04179175 about?
NCT04179175 is a clinical study titled "Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa". The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinum...
What is the current status of trial NCT04179175?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 703 participants. The study started on 2020-03-18. Estimated completion is 2026-07-15.
What conditions does trial NCT04179175 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa.
What interventions are being tested in trial NCT04179175?
The interventions under investigation include: secukinumab (DRUG).
Who is sponsoring clinical trial NCT04179175?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04179175 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04179175's enrollment target sits among peer trials
703 7th of 52 higher than 46 of 52 other Hidradenitis Suppurativa trials
participants (enrollment target), bucketed by value
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