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

Official title

A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Overview

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.

Detailed description

This is a global Phase 3, multicentre, double-blind, double-dummy, parallel-group extension study. It fulfils the Novartis commitment to provide post-trial access.

The study includes a double-blind and an open-label treatment phase:

Double-blind, double-dummy treatment continues from Week 68 (end of core study) until final database lock (DBL) of both core studies or until up titration. Participants remain on the same blinded regimen they were on during Treatment Period 2 of the preceding Phase 3 studies.

After final DBL of both core studies, treatment transitions to open-label.

Participants will continue treatment until commercial availability and reimbursement in their country, another access mechanism is available, or 4 years of extension treatment is completed.

Participants who discontinue treatment early or do not transition to commercial remibrutinib will enter a 4-week treatment-free safety follow-up.

Interventions

• Drug Remibrutinib
  Remibrutinib Dose A and B (oral)

Primary outcome measures

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

Secondary outcome measures (4)

• Proportion of participants with AN50/75/90 response [Time frame: Baseline, up to Week 276]
• Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4) [Time frame: Baseline, up to Week 276]
• Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response [Time frame: Baseline, up to Week 276]
• Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst [Time frame: Baseline, up to Week 276]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Argentina · 2 centers

• Novartis Investigative Site — Caba
• Novartis Investigative Site — CABA

Australia · 2 centers

• Novartis Investigative Site — Sydney
• Novartis Investigative Site — Melbourne

Identifiers

NCT: NCT07665437 · CLOU064J12303B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗