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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07665437
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Oct 27, 2031
Completion
Oct 27, 2031

Study Design

Enrollment
710 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remibrutinib Dose A
    Participants randomized during the core study to receive remibrutinib Dose A
  • Experimental: Remibrutinib Dose B
    Participants randomized during the core study to receive remibrutinib Dose B

Primary Outcome Measure

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, up to Week 280 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

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