A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Aventura, Boise, El Paso, Glenview, Greenacres City, Greenfield, Little Rock, Oklahoma City, Owensboro, and Pittsburgh, United StatesSee the 10 sitesAlso in 9 other countries, 33 sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 144 people enrolled
- Started
- 5 Apr 2023
- Ended
- 25 Apr 2024
- Type of study
- Interventional
- Treatments tested
- LOU064
- Record updated
- 16 October 2025
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Signed informed consent obtained prior to participation in the study
- Male and female adult participants >= 18 years of age
- CSU duration for >= 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
- Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of baseline (Day 1)
- Documentation of hives within three months before baseline (either at screening and/or at baseline (Day 1); or documented in the participants' medical history)
- Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the protocol
- Participants had no more than 2 missing UPDD entries (either morning or evening) in the 7 days prior to baseline (Day 1)
Who cannot take part
- Participants taking/requiring medications prohibited by the protocol (including those known to interfere with blood pressure assessments in the study)
- Ongoing or past history of hypertension and/or SBP >= 140 or =< 90 OR DBP >= 90 or =< 60 mmHg at screening
- 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
- Participants unable to tolerate 24-hour ambulatory blood pressure measurement using automatic ABPM device
- Participants working night shifts
Where in United States
Also in 9 other countries, 33 sites
- Florida Ctr Allergy Asthma ResearchAventura, United States
- Treasure Valley Medical ResearchBoise, United States
- Western Sky Medical ResearchEl Paso, United States
- Endeavor HealthGlenview, United States
- Finlay Medical ResearchGreenacres City, United States
- Allergy Asthma and amp Sinus Ctr S CGreenfield, United States
- Acuro Research, IncLittle Rock, United States
- Allergy, Asthma and Clinical ResearchOklahoma City, United States
- Allergy and Asthma Specialist P S COwensboro, United States
- Allergy and Clinical Immunology AssociatesPittsburgh, United States
About the trial
What the trial wants to find out
The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety and efficacy over 12 weeks in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled with second generation H1 antihistamines (H1-AH) treatment. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).
The group in the trial
- LOU064 (remibrutinib)Treatment being tested
All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
Treatment: LOU064
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 16 October 2025