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Sponsor: Novartis Pharmaceuticals
Conditions: Chronic Spontaneous Urticaria
Interventions: Remibrutinib, Placebo to remibrutinib, Placebo to omalizumab, Omalizumab
Countries: Argentina, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH). The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.
Sex: ALL
Age: 18 Years to 100 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Male and female adult participants ≥18 years of age at the time of signing the informed consent. * CSU duration for ≥ 6 months prior to screening. * Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as: * The presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period. * UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1). * Documentation of hives within three months before randomization. * Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol. * Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1). Exclusion Criteria: * Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies. * Significant bleeding risk or coagulation disorders. * History of gastrointestinal bleeding. * Requirement for anti-platelet or anti-coagulant medication. * History or current hepatic disease. * Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant. * Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. * Documented history of anaphylaxis. * Pregnant or nursing (lactating) women.
- CABA, Buenos Aires, Argentina
- Mendoza, Mendoza Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Bahía Blanca, Argentina
- CABA, Argentina
- Capital Federal, Argentina
- Porto Alegre, Rio Grande do Sul, Brazil
- Alphaville Barueri, São Paulo, Brazil
- Santo André, São Paulo, Brazil
- Sorocaba, São Paulo, Brazil
- Sofia, Bulgaria
- Sofia, Bulgaria
- Varna, Bulgaria
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Niagara Falls, Ontario, Canada
- Québec, Quebec, Canada
- Verdun, Quebec, Canada
- Brno, Czechia
- Plzen Bolevec, Czechia
- Prague, Czechia
- Nice, France, France
- Grenoble, France
- La Rochelle, France
- Pierre-Bénite, France
- Rouen, France
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Munich, Bavaria, Germany
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