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

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Hidradenitis Suppurativa

Interventions: Remibrutinib

Countries: Argentina, Australia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (4)

Caba, Buenos Aires, Argentina
CABA, Argentina
Sydney, New South Wales, Australia
Melbourne, Victoria, Australia