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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

36 sites in 11 countries.

About this study

Official 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

Conditions

Hidradenitis Suppurativa

Being tested

CFZ533, Placebo to CFZ533, LYS006, Placebo to LYS006, MAS825

Keywords

Hidradenitis suppurativa, acne inversa, platform study

Medical subject headings

Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• CFZ533Drug

  Also called iscalimab

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

• Placebo to CFZ533Drug

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

• LYS006Drug

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

• Placebo to LYS006Drug

  Placebo administered orally twice per day until Week 16.

• MAS825Drug

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

• Placebo to MAS825Drug

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

• LOU064 25mgDrug

  Also called remibrutinib

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

• LOU064 100mgDrug

  Also called remibrutinib

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

• Placebo to LOU064Drug

  Placebo administered orally twice per day until Week 16.

• VAY736Drug

  Also called ianalumab

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

• Placebo to VAY736Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 Feb 2019
2. Study start27 Feb 2019
3. Primary completion4 Dec 2024
4. Study completion11 Sep 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
• More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.