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A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs 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, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
This is a randomized, subject and investigator-blinded, placebo-controlled, multi-center and parallel-group non-confirmatory study to assess the efficacy, safety and tolerability of five investigational drugs, CFZ533 (iscalimab), LYS006, MAS825, LOU064 (remibrutinib) and VAY736 (ianalumab) in subjects with moderate to severe hidradenitis suppurativa. All participants from Cohorts A, B and C had planned a 16-week treatment period and 12-week safety follow up period. All participants for Cohort D had planned a 16-week treatment period and 4-week safety follow up period. All participants for Cohort E had planned a 16-week treatment period and a mandatory 16-week safety follow-up period, plus a conditional follow-up period for up to 84 weeks for a total maximum follow up period of 2 years. Cohorts A-D are completed and Cohort E is ongoing.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Olympian Clinical Research
Clearwater, Florida, United States
Park Avenue Dermatology PA
Orange Park, Florida, United States
University Of South Florida
Tampa, Florida, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
NorthShore University Health System
Evanston, Illinois, United States
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina MUSC
Charleston, South Carolina, United States
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Brussels, Belgium
Start Date
February 27, 2019
Primary Completion Date
December 4, 2024
Completion Date
December 11, 2026
Last Updated
February 6, 2026
248
ACTUAL participants
CFZ533
DRUG
Placebo to CFZ533
DRUG
LYS006
DRUG
Placebo to LYS006
DRUG
MAS825
DRUG
Placebo to MAS825
DRUG
LOU064 25mg
DRUG
LOU064 100mg
DRUG
Placebo to LOU064
DRUG
VAY736
DRUG
Placebo to VAY736
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06993233
NCT06888193
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07316192