Indication of the Parent ProtocolPhase 3NCT07456891
Remibrutinib Open Label Roll-over Post-trial Access Protocol
A Phase 3 study testing Remibrutinib in people with Indication of the Parent Protocol, run by Novartis Pharmaceuticals at 43 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Indication of the Parent Protocol
- What is being tested?
- Remibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 43 sitesin 9 countries
- Study dates
- 16 Apr 2026to 30 Jan 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical / administrative reasons).
- Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.
- Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.
Who cannot join
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
43 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
43 sites in 9 countries
South Korea9 sites, 9 recruiting
- Recruiting
Novartis Investigative Site
Daegu, Dalseo gu, 42602
- Recruiting
Novartis Investigative Site
Dongjak Gu, Seoul, 07061
- Recruiting
Novartis Investigative Site
Gwangju, 61469
- Recruiting
Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, 18450
- Recruiting
Novartis Investigative Site
Incheon, 21565
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
- Recruiting
Novartis Investigative Site
Seoul, 03722
- Recruiting
Novartis Investigative Site
Seoul, 07441
- Recruiting
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Spain9 sites, 9 recruiting
- Recruiting
Novartis Investigative Site
Alicante, 03010
- Recruiting
Novartis Investigative Site
Barcelona, Catalonia, 08003
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Córdoba, 14004
- Recruiting
Novartis Investigative Site
Granada, Andalusia, 18014
- Recruiting
Novartis Investigative Site
Las Palmas GC, 35010
- Recruiting
Novartis Investigative Site
Madrid, 28027
- Recruiting
Novartis Investigative Site
Valencia, 46015
- Recruiting
Novartis Investigative Site
Valencia, 46026
France6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Bordeaux, 33075
- Recruiting
Novartis Investigative Site
Brest, 29609
- Recruiting
Novartis Investigative Site
Montpellier, 34295
- Recruiting
Novartis Investigative Site
Paris, 75970
- Recruiting
Novartis Investigative Site
Pierre-Bénite, 69495
- Recruiting
Novartis Investigative Site
Rouen, 76031
Canada5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Fredericton, New Brunswick, E3B 1G9
- Recruiting
Novartis Investigative Site
Hamilton, Ontario, L8L 3C3
- Recruiting
Novartis Investigative Site
London, Ontario, N6H 5L5
- Recruiting
Novartis Investigative Site
Québec, Quebec, G1V 4W2
- Recruiting
Novartis Investigative Site
Verdun, Quebec, H4G 3E7
Poland5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Gdansk, 80-214
- Recruiting
Novartis Investigative Site
Gdansk, 80-546
- Recruiting
Novartis Investigative Site
Krosno, Krosno, 38-400
- Recruiting
Novartis Investigative Site
Poznan, Poland, 60-693
- Recruiting
Novartis Investigative Site
Poznan, 60-823
Czechia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Brno, 602 00
- Recruiting
Novartis Investigative Site
Plzen Bolevec, 323 00
- Recruiting
Novartis Investigative Site
Prague, 100 34
- Recruiting
Novartis Investigative Site
Prague, 150 06
Bulgaria3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Sofia, 1421
- Recruiting
Novartis Investigative Site
Sofia, 1431
- Recruiting
Novartis Investigative Site
Varna, 9009
Colombia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080020
Vietnam1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Hanoi, Vietnam, 100000
About this study
Official title: An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.
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.
Read the detailed description
There will be no screening period for this study. After completion of the appropriate consent process, eligible participants can start treatment with remibrutinib as soon as they enter the study. All participants must visit the study site for their enrollment visit to confirm eligibility and commence study participation. Participants will return to the study center at least every 16 weeks for resupply of study medication but may return earlier if needed.
Participants will receive remibrutinib at the dose and regimen they last received in the parent study.
Participants will continue to receive remibrutinib for up to 3 years or until one of the following occurs: no treatment benefit, participant wishes to discontinue trial participation or withdraws consent, protocol non-compliance, pregnancy, the investigator feels it is no longer in the participant's best interest to continue therapy, or the participant receives access to treatment with remibrutinib outside of a clinical study, whichever occurs first.
- Conditions
- Indication of the Parent Protocol
- Being tested
- Remibrutinib
- Keywords
- Remibrutinib, long-term, roll-over, open label, post-trial access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Remibrutinib film coated tablets in the respective dose strength of the parent study.
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib dose level 1 | Experimental | Remibrutinib film coated tablets in the respective dose strength of the parent study Receives: Drug: Remibrutinib |
| Remibrutinib dose level 2 | Experimental | Remibrutinib film coated tablets in the respective dose strength of the parent study Receives: Drug: Remibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with the occurrence of AEs or SAEs
Number of participants with the occurrence of AEs or SAEs
Measured: throughout the study, approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start16 Apr 2026
- Primary completion30 Jan 2033 (estimated)
- Study completion30 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication of the Parent ProtocolStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456891
- Sponsor's protocol ID
- CLOU064A2306B
- Other IDs
- 2025-524078-40-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.
- ClinicalTrials.gov ID
- NCT07456891
- Acronym / sponsor ID
- CLOU064A2306B
- Conditions
- Indication of the Parent Protocol
- Keywords
- Remibrutinib, long-term, roll-over, open label, post-trial access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 30 Jan 2033 (estimated)
- Study completion
- 30 Jan 2033 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There will be no screening period for this study. After completion of the appropriate consent process, eligible participants can start treatment with remibrutinib as soon as they enter the study. All participants must visit the study site for their enrollment visit to confirm eligibility and commence study participation. Participants will return to the study center at least every 16 weeks for resupply of study medication but may return earlier if needed.
Participants will receive remibrutinib at the dose and regimen they last received in the parent study.
Participants will continue to receive remibrutinib for up to 3 years or until one of the following occurs: no treatment benefit, participant wishes to discontinue trial participation or withdraws consent, protocol non-compliance, pregnancy, the investigator feels it is no longer in the participant's best interest to continue therapy, or the participant receives access to treatment with remibrutinib outside of a clinical study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remibrutinib dose level 1 | Experimental | Drug: RemibrutinibRemibrutinib film coated tablets in the respective dose strength of the parent study |
| Remibrutinib dose level 2 | Experimental | Drug: RemibrutinibRemibrutinib film coated tablets in the respective dose strength of the parent study |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical / administrative reasons).
- Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.
- Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.
Key exclusion criteria (4 listed)
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemibrutinibRemibrutinib film coated tablets in the respective dose strength of the parent study. | Drug | Remibrutinib dose level 1, Remibrutinib dose level 2 |
Primary outcome
Number of participants with the occurrence of AEs or SAEs
Time frame: throughout the study, approximately 7 years
Number of participants with the occurrence of AEs or SAEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remibrutinib in people with Indication of the Parent Protocol, run by Novartis Pharmaceuticals at 43 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in South Korea, Spain, France, Canada, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with the occurrence of AEs or SAEs (time frame: throughout the study, approximately 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.