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Recruiting Phase 3

Remibrutinib Open Label Roll-over Post-trial Access Protocol

NCT07456891 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2026-04-16
Last updated
2026-09-25

Condition(s) studied

Indication of the Parent Protocol

Investigational drug(s) / intervention(s)

Remibrutinib →

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: \- 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. Exclusion Criteria: 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

Primary outcome measure(s)

  • Number of participants with the occurrence of AEs or SAEs — throughout the study, approximately 7 years
    Number of participants with the occurrence of AEs or SAEs

Trial sites (40)

FacilityCityRegionStatus
Novartis Investigative Site Sofia Bulgaria Recruiting
Novartis Investigative Site Sofia Bulgaria Recruiting
Novartis Investigative Site Varna Bulgaria Recruiting
Novartis Investigative Site Fredericton New Brunswick Recruiting
Novartis Investigative Site Hamilton Ontario Recruiting
Novartis Investigative Site London Ontario Recruiting
Novartis Investigative Site Québec Quebec Recruiting
Novartis Investigative Site Verdun Quebec Recruiting
Novartis Investigative Site Brno Czechia Recruiting
Novartis Investigative Site Plzen Bolevec Czechia Recruiting
Novartis Investigative Site Prague Czechia Recruiting
Novartis Investigative Site Prague Czechia Recruiting
Novartis Investigative Site Bordeaux France Recruiting
Novartis Investigative Site Brest France Recruiting
Novartis Investigative Site Montpellier France Recruiting
Novartis Investigative Site Paris France Recruiting
Novartis Investigative Site Pierre-Bénite France Recruiting
Novartis Investigative Site Rouen France Recruiting
Novartis Investigative Site Krosno Krosno Recruiting
Novartis Investigative Site Poznan Poland Recruiting
Novartis Investigative Site Gdansk Poland Recruiting
Novartis Investigative Site Gdansk Poland Recruiting
Novartis Investigative Site Poznan Poland Recruiting
Novartis Investigative Site Daegu Dalseo gu Recruiting
Novartis Investigative Site Hwaseong-si Gyeonggi-do Recruiting
Novartis Investigative Site Suwon Gyeonggi-do Recruiting
Novartis Investigative Site Dongjak Gu Seoul Recruiting
Novartis Investigative Site Seoul Seoul Recruiting
Novartis Investigative Site Gwangju South Korea Recruiting
Novartis Investigative Site Incheon South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Barcelona Catalonia Recruiting
Novartis Investigative Site Alicante Spain Recruiting
Novartis Investigative Site Barcelona Spain Recruiting
Novartis Investigative Site Córdoba Spain Recruiting
Novartis Investigative Site Madrid Spain Recruiting
Novartis Investigative Site Valencia Spain Recruiting
Novartis Investigative Site Valencia Spain Recruiting
Novartis Investigative Site Hanoi Vietnam Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07456891 on ClinicalTrials.gov ↗ ← All trials in South Korea