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

Start date
Apr 16, 2026
Status verified
May 2026
Primary completion
Jan 30, 2033
Completion
Jan 30, 2033

Study Design

Enrollment
212 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