Status:
ACTIVE_NOT_RECRUITING
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
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 comparis...
Detailed Description
The study consists of 4 periods, and the total study duration is up to 112 weeks. Approximately 468 adult participants with CSU are expected to be randomized in the study. Screening period: A screeni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2027
Estimated Enrollment :
471 Patients enrolled
Trial Details
Trial ID
NCT06042478
Start Date
November 15 2023
End Date
July 20 2027
Last Update
December 29 2025
Active Locations (111)
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1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1414AIF
2
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, 2000
3
Novartis Investigative Site
Bahía Blanca, Argentina, B8000JRB
4
Novartis Investigative Site
CABA, Argentina, C1012AAY