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

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.

Conditions

• Hidradenitis Suppurativa

Interventions

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-27

Primary Completion

2024-12-04

Completion

2026-12-11

FDA Drug

Yes

Countries

• United States
• Austria
• Belgium
• Czechia
• Denmark
• France
• Germany
• Hungary
• Iceland
• Netherlands
• Spain

Study Locations