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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remibrutinib dose level 1 | Experimental | Remibrutinib film coated tablets in the respective dose strength of the parent study |
|
| Remibrutinib dose level 2 | Experimental | Remibrutinib film coated tablets in the respective dose strength of the parent study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remibrutinib | Drug | Remibrutinib film coated tablets in the respective dose strength of the parent study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with the occurrence of AEs or SAEs | Number of participants with the occurrence of AEs or SAEs | throughout the study, approximately 7 years |
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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 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).
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Sofia | 1421 | Bulgaria | ||
| Novartis Investigative Site |
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
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| Recruiting |
| Sofia |
| 1431 |
| Bulgaria |
| Novartis Investigative Site | Recruiting | Varna | 9009 | Bulgaria |
| Novartis Investigative Site | Recruiting | Hamilton | Ontario | L8L 3C3 | Canada |
| Novartis Investigative Site | Recruiting | London | Ontario | N6H 5L5 | Canada |
| Novartis Investigative Site | Recruiting | Québec | Quebec | G1V 4W2 | Canada |
| Novartis Investigative Site | Recruiting | Verdun | Quebec | H4G 3E7 | Canada |
| Novartis Investigative Site | Recruiting | Brno | 602 00 | Czechia |
| Novartis Investigative Site | Recruiting | Plzen Bolevec | 32300 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 100 34 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 150 06 | Czechia |
| Novartis Investigative Site | Recruiting | Bordeaux | 33075 | France |
| Novartis Investigative Site | Recruiting | Brest | 29609 | France |
| Novartis Investigative Site | Recruiting | Montpellier | 34295 | France |
| Novartis Investigative Site | Recruiting | Paris | 75970 | France |
| Novartis Investigative Site | Recruiting | Rouen | 76031 | France |
| Novartis Investigative Site | Recruiting | Gdansk | 80-214 | Poland |
| Novartis Investigative Site | Recruiting | Gdansk | 80-546 | Poland |
| Novartis Investigative Site | Recruiting | Krosno | 38-400 | Poland |
| Novartis Investigative Site | Recruiting | Poznan | 60-693 | Poland |
| Novartis Investigative Site | Recruiting | Poznan | 60-823 | Poland |
| Novartis Investigative Site | Recruiting | Daegu | Dalseo Gu | 42602 | South Korea |
| Novartis Investigative Site | Recruiting | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Recruiting | Dongjak Gu | Seoul | 07061 | South Korea |
| Novartis Investigative Site | Recruiting | Gwangju | 61469 | South Korea |
| Novartis Investigative Site | Recruiting | Incheon | 21565 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 07441 | South Korea |
| Novartis Investigative Site | Recruiting | Alicante | 03010 | Spain |
| Novartis Investigative Site | Recruiting | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 280796 | Spain |
| Novartis Investigative Site | Recruiting | Valencia | 46015 | Spain |
| Novartis Investigative Site | Recruiting | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| C000722911 | remibrutinib |
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