Last Update: Aug 19, 2026 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. ClinicalTrials.gov Identifier: [NCT07456891](https://clinicaltrials.gov/ct2/show/NCT07456891) Novartis Reference Number:CLOU064A2306B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study 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. 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. Condition Indication of the Parent Protocol Phase Phase3 Overall Status Recruiting Number of Participants648 Start Date Apr 16, 2026 Completion Date Jan 30, 2033 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### Remibrutinib 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 Bulgaria #### Novartis Investigative Site Recruiting Varna,9009,Bulgaria #### Novartis Investigative Site Recruiting Sofia,1431,Bulgaria #### Novartis Investigative Site Recruiting Sofia,1421,Bulgaria Canada #### Novartis Investigative Site Recruiting London,Ontario,N6h 5l5,Canada #### Novartis Investigative Site Recruiting Verdun,Quebec,H4g 3e7,Canada #### Novartis Investigative Site Recruiting Québec,Quebec,G1v 4w2,Canada #### Novartis Investigative Site Recruiting Hamilton,Ontario,L8l 3c3,Canada Czechia #### Novartis Investigative Site Recruiting Prague,150 06,Czechia #### Novartis Investigative Site Recruiting Prague,100 34,Czechia #### Novartis Investigative Site Recruiting Plzen Bolevec,32300,Czechia #### Novartis Investigative Site Recruiting Brno,602 00,Czechia France #### Novartis Investigative Site Recruiting Bordeaux,33075,France #### Novartis Investigative Site Recruiting Montpellier,34295,France #### Novartis Investigative Site Recruiting Paris,75970,France #### Novartis Investigative Site Recruiting Rouen,76031,France #### Novartis Investigative Site Recruiting Brest,29609,France Poland #### Novartis Investigative Site Recruiting Poznan,Poland,60-693,Poland #### Novartis Investigative Site Recruiting Krosno,Krosno,38-400,Poland #### Novartis Investigative Site Recruiting Poznan,60-823,Poland #### Novartis Investigative Site Recruiting Gdansk,80-546,Poland #### Novartis Investigative Site Recruiting Gdansk,80-214,Poland South Korea #### Novartis Investigative Site Recruiting Daegu,Dalseo gu,42602,South Korea #### Novartis Investigative Site Recruiting Hwaseong-si,Gyeonggi-do,18450,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,03080,South Korea #### Novartis Investigative Site Recruiting Gwangju,61469,South Korea #### Novartis Investigative Site Recruiting Dongjak Gu,Seoul,07061,South Korea #### Novartis Investigative Site Recruiting Incheon,21565,South Korea #### Novartis Investigative Site Recruiting Seoul,07441,South Korea #### Novartis Investigative Site Recruiting Suwon,Gyeonggi-do,16499,South Korea Spain #### Novartis Investigative Site Recruiting Valencia,46026,Spain #### Novartis Investigative Site Recruiting Barcelona,08035,Spain #### Novartis Investigative Site Recruiting Valencia,46015,Spain #### Novartis Investigative Site Recruiting Alicante,03010,Spain #### Novartis Investigative Site Recruiting Barcelona,Catalonia,08003,Spain #### Novartis Investigative Site Recruiting Madrid,28027,Spain Vietnam #### Novartis Investigative Site Recruiting Hanoi,Vietnam,100000,Vietnam ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: