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)
Novartis Pharmaceuticals
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).
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 s…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms. 3. CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization. The response to the provocation test for each CINDU subtype is required before randomization (either during scre…
Interventions
- DrugRemibrutinib
tablets
- DrugPlacebo
tablets
Locations (17)
- Ziaderm Research LLCNorth Miami Beach, Florida
- Endeavor HealthGlenview, Illinois
- Novartis Investigative SiteGrenoble
- Novartis Investigative SiteMontpellier
- Novartis Investigative SiteParis
- Novartis Investigative SitePierre-Bénite