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โ† Trials
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An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

RecruitingPhase 3Ages 18 Years - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Remibrutinib
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Where

44 sites
Total Skin and Beauty Dermatology Center PC
Birmingham, United States
Johnson Dermatology
Fort Smith, United States
Arkansas Research Trials
North Little Rock, United States
Ctr for Dermatology Clinical Res
Fremont, United States
USC Keck School of Medicine
Los Angeles, United States
Olive View UCLA Medical Center
Sylmar, United States
Clinical Trials Research Institute
Thousand Oaks, United States
Floridian Research Institute
Miami, United States

โ€ฆand 36 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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