Remibrutinib Open Label Roll-over Post-trial Access Protocol
Recruiting
Phase 3
Interventional Study
Indication of the Parent Protocol
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 648 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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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.
Trial Locations
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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 comp…
Contacts
Novartis Pharmaceuticals
CONTACT