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.
NCT ID: NCT05795153
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
144 participants
INTERVENTIONAL
2023-04-05
2024-04-25
Brief Summary
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Detailed Description
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At the end of the treatment phase, participants had the option to continue in an extension study (CLOU064A2303B (NCT05513001)) if approved in the country and at the site.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LOU064 (remibrutinib)
All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.
LOU064
One film-coated tablet (25 mg) was to be taken in the morning and evening, respectively, with a 12-hour interval at approximately the same time everyday.
Interventions
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LOU064
One film-coated tablet (25 mg) was to be taken in the morning and evening, respectively, with a 12-hour interval at approximately the same time everyday.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Ongoing or past history of hypertension and/or SBP \>= 140 or =\< 90 OR DBP \>= 90 or =\< 60 mmHg at screening
* Participants working night shifts
* Participants taking/requiring medications prohibited by the protocol (including those known to interfere with blood pressure assessments in the study)
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Acuro Research Inc
Little Rock, Arkansas, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Endeavor Health
Glenview, Illinois, United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Western Sky Medical Research
El Paso, Texas, United States
Allergy Asthma and amp Sinus Ctr S C
Greenfield, Wisconsin, United States
Novartis Investigative Site
Nueve de Julio, Buenos Aires, Argentina
Novartis Investigative Site
Sourigues, Buenos Aires, Argentina
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Santa Fe, Rosario, Argentina
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Rosario, Santa Fe Province, Argentina
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Calgary, Alberta, Canada
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Montreal, Quebec, Canada
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Angers, , France
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Antony, , France
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Brest, , France
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Montpellier, , France
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Paris, , France
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Reims, , France
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Saint-Mandé, , France
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Toulouse, , France
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Bramsche, Lower Saxony, Germany
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Göttingen, Lower Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Erlangen, , Germany
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Hanover, , Germany
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Marburg, , Germany
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Singapore, , Singapore
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Komárno, , Slovakia
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Levice, , Slovakia
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Nové Zámky, , Slovakia
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Daegu, Dalseo Gu, South Korea
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Suwon, Gyeonggi-do, South Korea
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Seoul, , South Korea
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Izmir, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2022-002838-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLOU064A2305
Identifier Type: -
Identifier Source: org_study_id
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