Actively Recruiting

Phase 3
Age: 18Years - 100Years
All Genders
NCT07456891

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Led by Novartis Pharmaceuticals · Updated on 2026-05-12

212

Participants Needed

3

Research Sites

354 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has completed treatment per protocol in a Novartis study of remibrutinib in dermatological or allergology indications
  • Participants benefiting from remibrutinib but unable to access it outside clinical studies
  • Investigator believes participant continues to benefit and benefits outweigh risks
  • Participant cannot obtain marketed remibrutinib through local programs or prescription/reimbursement guidelines
Not Eligible

You will not qualify if you...

  • Participant prematurely discontinued remibrutinib treatment in the parent study
  • Use of prohibited medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Novartis Investigative Site

London, Ontario, Canada, N6H 5L5

Actively Recruiting

2

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea, 42602

Actively Recruiting

3

Novartis Investigative Site

Gwangju, South Korea, 61469

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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