Sign in
CompletedPhase 3

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
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