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
Chronic Spontaneous Urticaria
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
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
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Kern Research, Bakersfield, California, United States, 93301
Pediatric Dermatology of Miami at the Pediatric CoE, Coral Gables, Florida, United States, 33134
Treasure Valley Medical Research, Boise, Idaho, United States, 83706
Northshore University Health System, Glenview, Illinois, United States, 60077
Allergy and Asthma Specialist P S C, Owensboro, Kentucky, United States, 42301
Toledo Institute of Clinical Research, Toledo, Ohio, United States, 43617
Allergy Asthma and Clinical Research, Oklahoma City, Oklahoma, United States, 73120
Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania, United States, 15241
RFSA Dermatology, San Antonio, Texas, United States, 78213
Allergy Associates of Utah, Sandy, Utah, United States, 84093
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
12 Years to 17 Years
ALL
No
Novartis Pharmaceuticals,
Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals
2032-02-04