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RECRUITING Phase 3 ClinicalTrials.gov

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07456891

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Remibrutinib (Drug)
    Remibrutinib film coated tablets in the respective dose strength of the parent study.

Eligibility criteria

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 Other protocol-defined inclusion/exclusion criteria may apply.

Conditions

Indication of the Parent Protocol

Locations

  • Novartis Investigative Site — Sofia, Bulgaria
  • Novartis Investigative Site — Sofia, Bulgaria
  • Novartis Investigative Site — Varna, Bulgaria
  • Novartis Investigative Site — Fredericton, New Brunswick, Canada
  • Novartis Investigative Site — Hamilton, Ontario, Canada
  • Novartis Investigative Site — London, Ontario, Canada
  • Novartis Investigative Site — Québec, Quebec, Canada
  • Novartis Investigative Site — Verdun, Quebec, Canada
  • Novartis Investigative Site — Barranquilla, Atlántico, Colombia
  • Novartis Investigative Site — Brno, Czechia
  • Novartis Investigative Site — Plzen Bolevec, Czechia
  • Novartis Investigative Site — Prague, Czechia
  • Novartis Investigative Site — Prague, Czechia
  • Novartis Investigative Site — Bordeaux, France
  • Novartis Investigative Site — Brest, France
  • Novartis Investigative Site — Montpellier, France
  • Novartis Investigative Site — Paris, France
  • Novartis Investigative Site — Pierre-Bénite, France
  • Novartis Investigative Site — Rouen, France
  • Novartis Investigative Site — Krosno, Krosno, Poland
  • Novartis Investigative Site — Poznan, Poland, Poland
  • Novartis Investigative Site — Gdansk, Poland
  • Novartis Investigative Site — Gdansk, Poland
  • Novartis Investigative Site — Poznan, Poland
  • Novartis Investigative Site — Daegu, Dalseo gu, South Korea
  • Novartis Investigative Site — Hwaseong-si, Gyeonggi-do, South Korea
  • Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea
  • Novartis Investigative Site — Dongjak Gu, Seoul, South Korea
  • Novartis Investigative Site — Seoul, Seoul, South Korea
  • Novartis Investigative Site — Gwangju, South Korea
  • Novartis Investigative Site — Incheon, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Granada, Andalusia, Spain
  • Novartis Investigative Site — Barcelona, Catalonia, Spain
  • Novartis Investigative Site — Alicante, Spain
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Córdoba, Spain
  • Novartis Investigative Site — Las Palmas GC, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Valencia, Spain
  • Novartis Investigative Site — Valencia, Spain
  • Novartis Investigative Site — Hanoi, Vietnam, Vietnam
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record