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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR)
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 pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts A, B, and C, the placebo data for cohorts D and E were incomplete and therefore excluded. Similarly, during the comparison for cohort D, the placebo data for cohort E was still pending and was not included.
Time frame: Baseline, Week 16
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Placebo administered orally twice per day until Week 16.
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
LOU064 25 mg administered orally twice per day until Week 16.
LOU064 100 mg administered orally twice per day until Week 16.
Placebo administered orally twice per day until Week 16.
VAY736 300 mg administered s.c every 4 weeks until Week 13.
Placebo administered s.c every 4 weeks until Week 13.
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
...and 26 more locations