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NCT Number: NCT03827798

Study of Efficacy and Safety of Investigational Treatments 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Graz, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CFZ533

Drug

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

Other names: iscalimab

Placebo to CFZ533

Drug

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

LYS006

Drug

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

Placebo to LYS006

Drug

Placebo administered orally twice per day until Week 16.

MAS825

Drug

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

Placebo to MAS825

Drug

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

LOU064 25mg

Drug

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

Other names: remibrutinib

LOU064 100mg

Drug

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

Other names: remibrutinib

Placebo to LOU064

Drug

Placebo administered orally twice per day until Week 16.

VAY736

Drug

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

Other names: ianalumab

Placebo to VAY736

Drug

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

Primary outcomes

  1. Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Feb 1, 2019
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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