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Study identifier: NCT07456891 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Condition: Indication of the Parent Protocol  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 3
Planned participants648
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where33 locations · 7 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  +41613241111  ·  novartis.email@novartis.com

Novartis Pharmaceuticals

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (33)

Novartis Investigative SiteSofia, BulgariaRecruiting
Novartis Investigative SiteSofia, BulgariaRecruiting
Novartis Investigative SiteVarna, BulgariaRecruiting
Novartis Investigative SiteHamilton, Ontario, CanadaRecruiting
Novartis Investigative SiteLondon, Ontario, CanadaRecruiting
Novartis Investigative SiteQuébec, Quebec, CanadaRecruiting
Novartis Investigative SiteVerdun, Quebec, CanadaRecruiting
Novartis Investigative SiteBrno, CzechiaRecruiting
Novartis Investigative SitePlzen Bolevec, CzechiaRecruiting
Novartis Investigative SitePrague, CzechiaRecruiting
Novartis Investigative SitePrague, CzechiaRecruiting
Novartis Investigative SiteBordeaux, FranceRecruiting

+ 21 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

SofiaVarnaHamiltonLondon

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