NCT03827798

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	CFZ533	CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
DRUG	Placebo to CFZ533	Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
DRUG	LYS006	LYS006 20 mg administered orally twice per day until Week 16.
DRUG	Placebo to LYS006	Placebo administered orally twice per day until Week 16.
DRUG	MAS825	MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
DRUG	Placebo to MAS825	Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
DRUG	LOU064 25mg	LOU064 25 mg administered orally twice per day until Week 16.
DRUG	LOU064 100mg	LOU064 100 mg administered orally twice per day until Week 16.
DRUG	Placebo to LOU064	Placebo administered orally twice per day until Week 16.
DRUG	VAY736	VAY736 300 mg administered s.c every 4 weeks until Week 13.
DRUG	Placebo to VAY736	Placebo administered s.c every 4 weeks until Week 13.

Timeline

• Start date: 2019-02-27
• Primary completion: 2024-12-04
• Completion: 2026-12-11
• First posted: 2019-02-01
• Last updated: 2026-02-06
• Results posted: 2026-02-06

Locations

36 sites across 11 countries: United States, Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Iceland, Netherlands, Spain

Regulatory

• FDA-regulated drug study