ClinicaliQ Trial Snapshot
- 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 –.
- Remibrutinib versus placebo for adolescent chronic urticaria inadequately controlled by antihistamines, with long-term safety follow-up.
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What This Trial Is Studying
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 Conditions: Chronic Spontaneous Urticaria Interventions: LOU064 (blinded), placebo Lead Sponsor: Novartis Pharmaceuticals Planned…