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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: CFZ533; Drug: LYS006; Drug: Placebo to CFZ533; Drug: Placebo to LYS006; Drug: MAS825; Drug: Placebo to MAS825; Drug: LOU064 25mg; Drug: LOU064 100mg; Drug: Placebo to LOU064; Drug: VAY736; Drug: Placebo to VAY736

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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Novartis Investigative Site
• Belgium
  • Brussels, Belgium, 1070
    • Novartis Investigative Site
• Czechia
  • Prague 1
    • Prague, Prague 1, Czechia, 11000
      • Novartis Investigative Site
• Denmark
  • Copenhagen, Denmark, 2400
    • Novartis Investigative Site
  • Roskilde, Denmark, 4000
    • Novartis Investigative Site
• France
  • Antony, France, 92160
    • Novartis Investigative Site
  • Lyon, France, 69003
    • Novartis Investigative Site
  • Marseille, France, 13885
    • Novartis Investigative Site
  • Nice, France, 06202
    • Novartis Investigative Site
  • Reims, France, 51100
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
• Germany
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Schwerin, Germany, 19055
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, H-1083
    • Novartis Investigative Site
  • Szeged, Hungary, H 6725
    • Novartis Investigative Site
  • Baranya
    • Pécs, Baranya, Hungary, 7623
      • Novartis Investigative Site
  • Hajdu Bihar Megye
    • Debrecen, Hajdu Bihar Megye, Hungary, 4032
      • Novartis Investigative Site
• Iceland
  • Kopavogur, Iceland, 201
    • Novartis Investigative Site
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Novartis Investigative Site
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Las Palmas GC, Spain, 35010
    • Novartis Investigative Site
  • Valencia, Spain, 46026
    • Novartis Investigative Site
  • Andalusia
    • Granada, Andalusia, Spain, 18014
      • Novartis Investigative Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Novartis Investigative Site
• United States
  • Florida
    • Clearwater, Florida, United States, 33609
      • Olympian Clinical Research
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology PA
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Health System
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Rea Group
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina MUSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A - CFZ533 600 mg; CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.	Drug: CFZ533; CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.; Other Names: iscalimab
Experimental: Cohort B - LYS006 20 mg; LYS006 20 mg administered orally twice per day until Week 16.	Drug: LYS006; LYS006 20 mg administered orally twice per day until Week 16.
Placebo Comparator: Cohort A - Placebo to CFZ533; Placebo 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.
Placebo Comparator: Cohort B - Placebo to LYS006; Placebo administered orally twice per day until Week 16.	Drug: Placebo to LYS006; Placebo administered orally twice per day until Week 16.
Experimental: Cohort C - MAS825 300 mg; MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.	Drug: MAS825; MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Placebo Comparator: Cohort C - Placebo to MAS825; Placebo 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.
Experimental: Cohort D - LOU064 25mg; LOU064 25 mg administered orally twice per day until Week 16.	Drug: LOU064 25mg; LOU064 25 mg administered orally twice per day until Week 16.; Other Names: remibrutinib
Experimental: Cohort D - LOU064 100mg; LOU064 100 mg administered orally twice per day until Week 16.	Drug: LOU064 100mg; LOU064 100 mg administered orally twice per day until Week 16.; Other Names: remibrutinib
Placebo Comparator: Cohort D - Placebo to LOU064; Placebo administered orally twice per day until Week 16.	Drug: Placebo to LOU064; Placebo administered orally twice per day until Week 16.
Experimental: Cohort E - VAY736 300 mg; VAY736 300 mg administered s.c every 4 weeks until Week 13.	Drug: VAY736; VAY736 300 mg administered s.c every 4 weeks until Week 13.; Other Names: ianalumab
Placebo Comparator: Cohort E - Placebo to VAY736; Placebo administered s.c every 4 weeks until Week 13.	Drug: Placebo to VAY736; Placebo administered s.c every 4 weeks until Week 13.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): December 4, 2024
• Study Completion (Estimated): December 11, 2026

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Hidradenitis suppurativa; acne inversa; platform study
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Immunologic Factors; Physiological Effects of Drugs; ianalumab; remibrutinib; iscalimab
• Other Study ID Numbers: CCFZ533H12201BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No