Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global Phase 3 extension study for adults with moderate to severe hidradenitis suppurativa who completed preceding trials. It uses a double-blind, double-dummy design during the core period and then transitions to an open-label phase, allowing continued treatment until a commercial option is available or up to four years. Participants keep the same blinded regimen from the prior treatment period through the end of the core studies, and may transition to open-label remibrutinib thereafter. The study aims to assess long-term safety, tolerability, and efficacy, with eligibility limited to those who completed 68 weeks of the core trials and meet safety criteria. The sponsor is Novartis Pharmaceuticals, with participating sites in select U.S. dermatology centers.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Signed informed consent must be obtained before any assessment is performed.
* 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.

Key Exclusion Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Total Skin and Beauty Dermatology Center PC
  Birmingham, Alabama, United States Recruiting
• Johnson Dermatology
  Fort Smith, Arkansas, United States Recruiting
• Arkansas Research Trials
  North Little Rock, Arkansas, United States Recruiting
• Ctr for Dermatology Clinical Res
  Fremont, California, United States Recruiting
• USC Keck School of Medicine
  Los Angeles, California, United States Recruiting
• Olive View UCLA Medical Center
  Sylmar, California, United States Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.