2022-502161-19-00RecruitingPhase 3
A global, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase 3b study to assess the efficacy, safety, and tolerability of remibrutinib 25 mg b.i.d. in comparison to placebo with omalizumab 300 mg every 4 weeks as active control over 52 weeks in adult patients with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines and an open-label 52-week optional extension to assess long-term efficacy, safety and tolerability of remibrutinib 25 mg b.i.d.
Novartis Pharma AG63 sites in 6 countries214 target enrollmentStarted: February 12, 2024Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Novartis Pharma AG
- Enrollment
- 214
- Locations
- 63
- Primary Endpoint
- Absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12
Study Overview
Brief Summary
To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7, ISS7 and HSS7 at Week 12.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
-
Auxiliary
Participants receiving -
Intervention: - (Drug)
Outcomes
Primary Outcomes
Absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12
Absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12
Secondary Outcomes
- Achievement of UAS7=0 (yes/no) at Week 12
- Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12
- Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 12
- Absolute change from baseline in UAS7 at Week 12
- Occurrence of treatment-emergent adverse events and serious adverse events (SAEs) during the study
Investigators
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
Study Sites (63)
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