Remibrutinib Open Label Roll-over Post-trial Access Protocol
ConditionIndication of the Parent Protocol
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Participant has prematurely discontinued study treatment in the parent study.
Use of prohibited medications
Trial design
Design model
Parallel
Treatments tested in this trial
Remibrutinib
DrugRemibrutinib film coated tablets in the respective dose strength of the parent study.
Treatment groups
648 Participants
are divided into 2 treatment groupsGroup A: Remibrutinib dose level 1Experimental treatment 1 intervention
Group B: Remibrutinib dose level 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with the occurrence of AEs or SAEs
Number of participants with the occurrence of AEs or SAEs
Time frame
throughout the study, approximately 7 yearsSponsors and contacts
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Source ClinicalTrials.gov