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.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Argentina, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary, India, Italy, Malaysia, Mexico, Netherlands, Poland, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Türkiye, United Kingdom, and Vietnam112 sites in 23 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 470 people enrolled
- Started
- 15 Nov 2023
- Expected to end
- 20 Jul 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Remibrutinib
- Placebo to remibrutinib
- Placebo to omalizumab
- Omalizumab
- Record updated
- 14 October 2026
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- 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
- 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
- Requirement for anti-platelet or anti-coagulant medication
- Pregnant or nursing (lactating) women
This trial has no sites in United States.
It has sites in 23 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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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.
The 4 groups in the trial
- RemibrutinibTreatment being tested
Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.
- Placebo to remibrutinibPlacebo, for comparison
Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w.
- Placebo to omalizumabPlacebo, for comparison
Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d.
- OmalizumabExisting treatment, for comparison
participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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.
- Record updated
- 14 October 2026