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

Novartis

Status and phase: Active, not recruiting; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo to CFZ533; Drug: VAY736; Drug: LOU064 100mg; Drug: Placebo to LOU064; Drug: LOU064 25mg; Drug: Placebo to LYS006; Drug: LYS006; Drug: Placebo to VAY736; Drug: CFZ533; Drug: Placebo to MAS825; Drug: MAS825

Study type: Interventional

Funder types: Industry

Identifiers

NCT03827798

CCFZ533H12201BC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved
• Minimal body weight of 50 kg
• Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule

Exclusion criteria

• Use of other investigational drugs at the time of screening or before
• Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
• Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 11 patient groups, including a placebo group

Cohort A - CFZ533 600 mg

Experimental group

Description:

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

Treatment:

Drug: CFZ533

Cohort B - LYS006 20 mg

Experimental group

Description:

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

Treatment:

Drug: LYS006

Cohort A - Placebo to CFZ533

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to CFZ533

Cohort B - Placebo to LYS006

Placebo Comparator group

Description:

Placebo administered orally twice per day until Week 16.

Treatment:

Drug: Placebo to LYS006

Cohort C - MAS825 300 mg

Experimental group

Description:

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

Treatment:

Drug: MAS825

Cohort C - Placebo to MAS825

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to MAS825

Cohort D - LOU064 25mg

Experimental group

Description:

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

Treatment:

Drug: LOU064 25mg

Cohort D - LOU064 100mg

Experimental group

Description:

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

Treatment:

Drug: LOU064 100mg

Cohort D - Placebo to LOU064

Placebo Comparator group

Description:

Placebo administered orally twice per day until Week 16.

Treatment:

Drug: Placebo to LOU064

Cohort E - VAY736 300 mg

Experimental group

Description:

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

Treatment:

Drug: VAY736

Cohort E - Placebo to VAY736

Placebo Comparator group

Description:

Placebo administered s.c every 4 weeks until Week 13.

Treatment:

Drug: Placebo to VAY736