Clinical trial
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
NCT05677451 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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
- Lead sponsor
- Novartis Pharmaceuticals
- Phase
- Phase 3
- Overall status
- Active, not recruiting
- Start date
- July 11, 2023
- Completion date
- March 30, 2032
- Enrollment
- 100 (actual)
- Sites
- 49
Conditions
As the registry lists them; a condition with its own page is linked.
chronic spontaneous urticaria