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New treatment option for Indication of the Parent Protocol
Official title Remibrutinib Open Label Roll-over Post-trial Access Protocol
ClinicalTrials.gov ID: NCT07456891
What this study is testing
What is Remibrutinib?
Remibrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for indication of the parent protocol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- \- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a...
- Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit...
- Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or...
You likely can't join if
- Participants meeting any of the following criteria are not eligible for inclusion in this study.
- Participant has prematurely discontinued study treatment in the parent study.
- Use of prohibited medications
The study team makes the final eligibility decision.
Where it's taking place
- Sofia, Bulgaria
- Varna, Bulgaria
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Québec, Quebec, Canada
- Verdun, Quebec, Canada
- Brno, Czechia
- Plzen Bolevec, Czechia
- Prague, Czechia
- Bordeaux, France
- Brest, France
- Montpellier, France
- Paris, France
- Rouen, France
- Gdansk, Poland
- Krosno, Poland
- Poznan, Poland
- Daegu, Dalseo Gu, South Korea
- Suwon, Gyeonggi-do, South Korea
- Dongjak Gu, Seoul, South Korea
+ 7 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sofia, Bulgaria; Varna, Bulgaria; Hamilton, Ontario, Canada; London, Ontario, Canada; Québec, Quebec, Canada; Verdun, Quebec, Canada and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.