Remibrutinib Open Label Roll-over Post-trial Access Protocol

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07456891
Phase
PHASE3
Status
Recruiting
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Conditions

  • Indication of the Parent Protocol

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Remibrutinib — DRUG
    Remibrutinib film coated tablets in the respective dose strength of the parent study.

Study Details

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.

Key Dates

First listed
Mar 9, 2026
Start date
Apr 16, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2033
Completion
Jan 30, 2033

Study Design

Enrollment
648 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remibrutinib dose level 1
    Remibrutinib film coated tablets in the respective dose strength of the parent study
  • Experimental: Remibrutinib dose level 2
    Remibrutinib film coated tablets in the respective dose strength of the parent study

Primary Outcome Measure

Number of participants with the occurrence of AEs or SAEs [ Time Frame: throughout the study, approximately 7 years ]

Central Contacts