Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Condition(s) studied

Investigational drug(s) / intervention(s)

CFZ533: CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.

Placebo to CFZ533: Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.

LYS006: LYS006 20 mg administered orally twice per day until Week 16.

Placebo to LYS006: Placebo administered orally twice per day until Week 16.

MAS825: MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.

Placebo to MAS825: Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.

LOU064 25mg: LOU064 25 mg administered orally twice per day until Week 16.

LOU064 100mg: LOU064 100 mg administered orally twice per day until Week 16.

Placebo to LOU064: Placebo administered orally twice per day until Week 16.

VAY736: VAY736 300 mg administered s.c every 4 weeks until Week 13.

Placebo to VAY736: Placebo administered s.c every 4 weeks until Week 13.

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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) — Baseline, Week 16
  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.

Trial sites (36)