A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
Novartis Pharmaceuticals
Summary
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment
Description
This trial consists of 3 different periods: 1. the "core period", which is randomized and double-blind, during which 2/3 participants will receive remibrutinib and 1/3 will receive placebo for 24 weeks. Total duration: approximately 32 weeks (10 site visits). 2. an optional "open-label extension (OLE) period" proposed to all participants who completed 24 weeks of treatment of the "core period" and all scheduled assessments planned at week 24 visit . Depending on their CSU symptoms (as assessed by the doctor), participants will either receive remibrutinib for 24 weeks, or enter an observationa…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Male and female adolescent participants aged \>= 12 to \< 18 years of age at the time of signing the informed consent * CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation) * Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as: * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines…
Interventions
- DrugLOU064 (blinded)
LOU064 (blinded) active treatment
- Drugplacebo
matching active drug
Locations (65)
- Kern ResearchBakersfield, California
- Allergy and Asthma Medical Group and Research CenterSan Diego, California
- Pediatric Dermatology of Miami at the Pediatric CoEMiami, Florida
- Treasure Valley Medical ResearchBoise, Idaho
- Endeavor HealthGlenview, Illinois
- Allergy and Asthma Specialist P S COwensboro, Kentucky