Ended Therapeutic exploratory (Phase II) Moderate to severe hidradenitis suppurativa

A study to assess different investigational drugs for the treatment if hidradenitis suppurativa

EU CTIS ID: 2023-509296-16-00

What this study is testing

To assess the efficacy of the investigational treatments, compared to placebo in moderate to severe inflammatory HS patients

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male and female patients, 18 to 65 years of age (inclusive), with clinically diagnosed HS for at least 12 months prior to Screening.
  • For Cohort A (iscalimab), C (MAS825) and E (VAY736): A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules.
  • For Cohort B (LYS006) and D (LOU064): A total of at least 3 inflammatory lesions, i.e., abscesses and/or inflammatory nodules.
  • For all Cohorts: No more than 15 fistulae and at least two anatomical areas need to be involved with HS lesions.

You likely can't join if

  • Use of other investigational drugs at the time of screening, or within 30 days or 5 half-lives of randomization, whichever is longer; or longer if required by local regulations.
  • Use/receipt of some specific treatments during specified time frames, depending on the cohort.
  • WoCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for the subsequent 14 weeks after the last study drug administration for Cohort A (iscalimab) and the subsequent 2 weeks after the last study drug administration for Cohort B (LYS006) and D (remibrutinib). In Cohort C, WoCBP will be asked to adhere to highly effective contraception from at least 3 months prior to first drug administration and until 5 months after the final dose (Day 225 to Day 253), when a pregnancy test will be conducted. In Cohort E, WoCBP will be required to adhere to highly effective contraception for 6 months after the final dose (Day 253 to Day 281).

The study team makes the final eligibility decision.

Where it's taking place

  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.