24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Chronic Spontaneous Urticaria
In brief
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
Key facts
- Study ID
- NCT05677451
- Run by
- Novartis Pharmaceuticals
- People needed
- 100
- Starts
- 2023-07-11
- Expected to finish
- 2032-03-30
- Last updated by the study team
- 2026-07-20
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Siena, SI, Italy
- Kern Research — Bakersfield, California, United States
- Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
- Pediatric Dermatology of Miami at the Pediatric CoE — Miami, Florida, United States
- Treasure Valley Medical Research — Boise, Idaho, United States
- Endeavor Health — Glenview, Illinois, United States
- Allergy and Asthma Specialist P S C — Owensboro, Kentucky, United States
- Toledo Institute of Clinical Research — Toledo, Ohio, United States
- Allergy Asthma and Clinical Research — Oklahoma City, Oklahoma, United States
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
- RFSA Dermatology — San Antonio, Texas, United States
- Allergy Associates of Utah — Sandy City, Utah, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
- Novartis Investigative Site — CABA, Argentina
- Novartis Investigative Site — San Miguel de Tucumán, Argentina
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Santiago, Santiago Metropolitan, Chile
- Novartis Investigative Site — Guangzhou, Guangdong, China
- Novartis Investigative Site — Chengdu, Sichuan, China
- Novartis Investigative Site — Beijing, China
- Novartis Investigative Site — Beijing, China
- Novartis Investigative Site — Frankfurt am Main, Hesse, Germany
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Tübingen, Germany
Full record on ClinicalTrials.gov
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