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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Remibrutinib
  Remibrutinib Dose A and B (oral)

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Аргентина · 2 центра

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

Австралия · 2 центра

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

Идентификаторы

NCT: NCT07665437 · CLOU064J12303B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗