A Phase 3 extension study to assess the long-term safety and efficacy of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
EU CTIS ID: 2025-523259-72-00
What this study is testing
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe HS
- Therapeutic confirmatory (Phase III)
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
- Signed informed consent must be obtained before any assessment is performed.
- Ability to communicate effectively with the Investigator, to understand and willing to comply with the requirements of the study
- Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
- Participant does not meet any treatment discontinuation criteria of the core study at Week 68
You likely can't join if
- Ongoing or planned use of prohibited HS or non-HS treatments
- Participants not expected to benefit from participation in the extension study, or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
- Current severe progressive or uncontrolled disease which in the judgment of the Investigator renders the participant unsuitable for the study
- Pregnant or lactating women or female participants who are planning to become pregnant during the study or within 4 weeks following the final dose of study treatment
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 7 days after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
The study team makes the final eligibility decision.
Where it's taking place
- Germany
- France
- Spain
- Czechia
- South Africa
- China
- Taiwan
- Argentina
- Turkey
- Australia
- United Kingdom
- Malaysia
- United States
- Switzerland
- Mexico
- Colombia
- Canada
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, but 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Germany; France; Spain; Czechia; South Africa; China and 11 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.