This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
Chronic Inducible Urticaria
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
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Allervie Clinical Research, Birmingham, Alabama, United States, 35209
Little Rock Allergy and Asthma Clnc, Little Rock, Arkansas, United States, 72205
Kern Research, Bakersfield, California, United States, 93301
Allergy and Asthma Specialists Medical Group and Research Ct, Huntington Beach, California, United States, 92647
Antelope Valley Clinical Trials, Lancaster, California, United States, 93534
Asthma and Allergy Associates P C, Colorado Springs, Colorado, United States, 80907
Florida Ctr Allergy Asthma Research ., Aventura, Florida, United States, 33180
Florida Ctr Allergy Asthma Research, Aventura, Florida, United States, 33180
Finlay Medical Research, Greenacres City, Florida, United States, 33467
Sarasota Clinical Research ., Sarasota, Florida, United States, 34233
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.
18 Years to
ALL
No
Novartis Pharmaceuticals,
Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals
2028-12-31