Remibrutinib Open Label Roll-over Post-trial Access Protocol

Официальное название

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.

Обзор

Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a Novartis-sponsored study, who are benefiting from treatment with remibrutinib, and are unable to access remibrutinib treatment outside of a clinical study.

Подробное описание

There will be no screening period for this study. After completion of the appropriate consent process, eligible participants can start treatment with remibrutinib as soon as they enter the study. All participants must visit the study site for their enrollment visit to confirm eligibility and commence study participation. Participants will return to the study center at least every 16 weeks for resupply of study medication but may return earlier if needed.

Participants will receive remibrutinib at the dose and regimen they last received in the parent study.

Participants will continue to receive remibrutinib for up to 3 years or until one of the following occurs: no treatment benefit, participant wishes to discontinue trial participation or withdraws consent, protocol non-compliance, pregnancy, the investigator feels it is no longer in the participant's best interest to continue therapy, or the participant receives access to treatment with remibrutinib outside of a clinical study, whichever occurs first.

Вмешательства

• Препарат Remibrutinib
  Remibrutinib film coated tablets in the respective dose strength of the parent study.

Первичные конечные точки

• Number of participants with the occurrence of AEs or SAEs [Срок оценки: throughout the study, approximately 7 years]

Критерии участия

Критерии включения

\- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication.

Participants, who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical / administrative reasons).

• Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.
• Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.

Критерии исключения

Participants meeting any of the following criteria are not eligible for inclusion in this study.

• Participant has prematurely discontinued study treatment in the parent study.
• Use of prohibited medications

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 7 центров

• Novartis Investigative Site — Daegu
• Novartis Investigative Site — Suwon
• Novartis Investigative Site — Dongjak Gu
• Novartis Investigative Site — Gwangju
• Novartis Investigative Site — Incheon
• Novartis Investigative Site — Seoul
• Novartis Investigative Site — Seoul

Франция · 5 центров

• Novartis Investigative Site — Bordeaux
• Novartis Investigative Site — Brest
• Novartis Investigative Site — Montpellier
• Novartis Investigative Site — Paris
• Novartis Investigative Site — Rouen

Польша · 5 центров

• Novartis Investigative Site — Gdansk
• Novartis Investigative Site — Gdansk
• Novartis Investigative Site — Krosno
• Novartis Investigative Site — Poznan
• Novartis Investigative Site — Poznan

Испания · 5 центров

• Novartis Investigative Site — Alicante
• Novartis Investigative Site — Barcelona
• Novartis Investigative Site — Madrid
• Novartis Investigative Site — Valencia
• Novartis Investigative Site — Valencia

Канада · 4 центра

• Novartis Investigative Site — Hamilton
• Novartis Investigative Site — London
• Novartis Investigative Site — Québec
• Novartis Investigative Site — Verdun

Чехия · 4 центра

• Novartis Investigative Site — Brno
• Novartis Investigative Site — Plzen Bolevec
• Novartis Investigative Site — Prague
• Novartis Investigative Site — Prague

Болгария · 3 центра

• Novartis Investigative Site — Sofia
• Novartis Investigative Site — Sofia
• Novartis Investigative Site — Varna

Идентификаторы

NCT: NCT07456891 · CLOU064A2306B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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