Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06865651
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)
Status:
RECRUITING
Status Verified Date:
2025-12
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 study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).
Detailed Description:
This is a randomized, parallel-group, participant and investigator-blinded, placebo controlled, multi-center study in approximately 44 adult participants that are diagnosed with a form of CU and have symptoms despite treatment with H1-antihistamines. The following nine subtypes of CU are included:
* CINDU cohorts: Symptomatic dermographism, Cold urticaria, Cholinergic urticaria, Heat urticaria, Solar urticaria, Delayed pressure urticaria, Aquagenic urticaria, Contact urticaria
* CSU The study will attempt to enroll approximately 4-5 participants for each subtype. Participants will undergo a screening period for completion of the assessment to check eligibility criteria which will take approximately up to 4 weeks. After enrollment, the treatment will be initiated. Participants will either receive remibrutinib or placebo for 12 weeks. Participants have an end of study visit approximately 7 days after the last dose. All participants will have a safety follow-up phone call approximately 30 days after last treatment administration.
* CINDU cohorts: Symptomatic dermographism, Cold urticaria, Cholinergic urticaria, Heat urticaria, Solar urticaria, Delayed pressure urticaria, Aquagenic urticaria, Contact urticaria
* CSU The study will attempt to enroll approximately 4-5 participants for each subtype. Participants will undergo a screening period for completion of the assessment to check eligibility criteria which will take approximately up to 4 weeks. After enrollment, the treatment will be initiated. Participants will either receive remibrutinib or placebo for 12 weeks. Participants have an end of study visit approximately 7 days after the last dose. All participants will have a safety follow-up phone call approximately 30 days after last treatment administration.
Study Oversight
Has Oversight DMC:
False
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?: