Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05513001
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2022-08-22
Brief Title:
An Extension Study of Long-term Efficacy Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multicenter Double-blind Placebo-controlled Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy Safety and Tolerability of Remibrutinib LOU064 in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this extension study is to collect long-term efficacy safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria CSU who previously completed the treatment phase of remibrutinib preceding Phase 3 studies
This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies where applicable
This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies where applicable
Detailed Description:
This is a global multicenter randomized double-blind placebo-controlled randomized withdrawal Phase 3b extension study followed by long-term open label treatment cycles to assess the efficacy safety and tolerability of remibrutinib in adult participants with CSU inadequately controlled by H1-AH The study comprises 2 Epochs Epoch 1 is the initial study period for participants who completed preceding remibrutinib Phase 3 studies Epoch 1 comprises of a 24-week randomized withdrawal period with remibrutinib or placebo for patients with UAS716 OR a 24 week Open-label treatment period with remibrutinib for patients with UAS716
Participants will be randomized in a 11 ratio to enter the double-blind placebo-controlled 24-week withdrawal phase In case of relapse UAS716 in the blinded group participants enter the Re-treatment period Epoch 1 and receive 24 weeks of Open-label treatment with remibrutinib At the end of the Re-treatment period Epoch 1 participants will move to Epoch 2
Epoch 2 is the second subsequent study period and consists of 24-week cycles that could either encompass treatment-free Observation andor Open-label Re-treatment periods with remibrutinib with or without background H1-AH
In case of relapse UAS716 during an Observation period participants enter the next Re-treatment period and receive 24 weeks of treatment with remibrutinib Participants completing an Observation period 2345 with a UAS76 will complete the study Participants with a UAS7 6 -16 can enter the next Re-treatment period if continuous treatment is considered necessary and beneficial for the individual participant For participants with a UAS716 that enter the next Re-treatment period remibrutinib monotherapy treatment without background H1-AH is required
Participants will be randomized in a 11 ratio to enter the double-blind placebo-controlled 24-week withdrawal phase In case of relapse UAS716 in the blinded group participants enter the Re-treatment period Epoch 1 and receive 24 weeks of Open-label treatment with remibrutinib At the end of the Re-treatment period Epoch 1 participants will move to Epoch 2
Epoch 2 is the second subsequent study period and consists of 24-week cycles that could either encompass treatment-free Observation andor Open-label Re-treatment periods with remibrutinib with or without background H1-AH
In case of relapse UAS716 during an Observation period participants enter the next Re-treatment period and receive 24 weeks of treatment with remibrutinib Participants completing an Observation period 2345 with a UAS76 will complete the study Participants with a UAS7 6 -16 can enter the next Re-treatment period if continuous treatment is considered necessary and beneficial for the individual participant For participants with a UAS716 that enter the next Re-treatment period remibrutinib monotherapy treatment without background H1-AH is required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001034-11 | EUDRACT_NUMBER | None | None |