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NCT03827798 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT03827798: Active Phase 2 study of Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals.
NCT03827798 is a Phase 2 study of Hidradenitis Suppurativa that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 248 participants, below the 593-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03827798, a Phase 2 study of Hidradenitis Suppurativa, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
Primary Outcome
sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and poo
Conditions Studied
Interventions
- DRUG MAS825
- DRUG CFZ533
- DRUG Placebo to CFZ533
- DRUG LYS006
- DRUG Placebo to LYS006
Study Locations (20)
Other
- Novartis Investigative Site - Graz
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Roskilde
- Novartis Investigative Site - Antony
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Nice
- Novartis Investigative Site - Reims
- Novartis Investigative Site - Rouen
- Novartis Investigative Site - Bochum
Florida
- Olympian Clinical Research - Clearwater
- Park Avenue Dermatology PA - Orange Park
- University Of South Florida - Tampa
Georgia
- Advanced Medical Research - Sandy Springs
Illinois
- NorthShore University Health System - Evanston
Indiana
- Dawes Fretzin Clinical Rea Group - Indianapolis
Pennsylvania
- Penn State Milton S Hershey Medical Center - Hershey
South Carolina
- Medical University of South Carolina MUSC - Charleston
Prague 1
- Novartis Investigative Site - Prague
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2026-12-11 |
| Phase | Phase 2 |
What the registry record for NCT03827798 still lists
NCT03827798 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 593-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 5 interventions - of which MAS825 is the first listed.
NCT03827798 names 20 study sites across 8 states, led by Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03827798 about?
NCT03827798 is a clinical study titled "Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa". The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LY...
What is the current status of trial NCT03827798?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2019-02-27. Estimated completion is 2026-12-11.
What conditions does trial NCT03827798 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa.
What interventions are being tested in trial NCT03827798?
The interventions under investigation include: MAS825 (DRUG), CFZ533 (DRUG), Placebo to CFZ533 (DRUG), LYS006 (DRUG), Placebo to LYS006 (DRUG).
Who is sponsoring clinical trial NCT03827798?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03827798 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, Indiana, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03827798's enrollment target sits among peer trials
248 19th of 52 higher than 34 of 52 other Hidradenitis Suppurativa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hidradenitis Suppurativa 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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