A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
Launched by NOVARTIS PHARMACEUTICALS · Aug 31, 2021
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
The study consisted of four periods, the total study duration was up to 60 weeks: Screening period of up to 4 weeks, Double-blind placebo-controlled treatment period of 24 weeks, Open-label treatment period with Remibrutinib period of 28 weeks, and treatment free follow-up period of 4 weeks.
The design of this study was a replicate of another Phase III study, CLOU046A2301 (NCT05030311).
The study population consisted of female and male adult patients with CSU inadequately controlled by second generation H1-AHs at least at a locally label approved dose. All patients were on a stable, local...
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Signed informed consent must be obtained prior to participation in the study.
- • Male and female adult participants \>= 18 years of age at the time of screening.
- • 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-antihistamines 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-antihistamines 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 (either at screening and/or at randomization; 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 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).
- Key Exclusion Criteria:
- • Participants having a clearly defined predominant or sole trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
- • Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
- • Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
- • Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), 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
- • Significant bleeding risk or coagulation disorders
- • History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion)
- • Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.
- • Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))
- • History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bern, , Switzerland
Kosice, , Slovakia
Savannah, Georgia, United States
Savannah, Georgia, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Leipzig, , Germany
Mainz, , Germany
Leeds, , United Kingdom
Salt Lake City, Utah, United States
San Antonio, Texas, United States
Taichung, , Taiwan
Taoyuan, , Taiwan
Graz, , Austria
Bangkok, , Thailand
Tuebingen, , Germany
Pittsburgh, Pennsylvania, United States
San Diego, California, United States
Dresden, , Germany
Little Rock, Arkansas, United States
San Diego, California, United States
Orlando, Florida, United States
Little Silver, New Jersey, United States
Guangzhou, Guangdong, China
Chiang Mai, , Thailand
Presov, , Slovakia
Tübingen, , Germany
Missoula, Montana, United States
Tampa, Florida, United States
Bangkok, , Thailand
Boise, Idaho, United States
Skokie, Illinois, United States
Kalispell, Montana, United States
Mayfield Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Seattle, Washington, United States
New Delhi, , India
Pittsburgh, Pennsylvania, United States
River Forest, Illinois, United States
Birmingham, Alabama, United States
Baltimore, Maryland, United States
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Beijing, , China
Tianjin, , China
Kosice, Slovak Republic, Slovakia
Pembroke Pines, Florida, United States
Cardiff, , United Kingdom
Leeds, West Yorkshire, United Kingdom
Missoula, Montana, United States
Oxford, , United Kingdom
Warszawa, , Poland
Warszawa, , Poland
Tampa, Florida, United States
High Point, North Carolina, United States
Spokane, Washington, United States
Clearwater, Florida, United States
Wuhan, Hubei, China
Tianjin, Tianjin, China
Beijing, , China
Nagpur, Maharashtra, India
San Diego, California, United States
San Antonio, Texas, United States
Guangzhou, Guangdong, China
Shanghai, Shanghai, China
Waldorf, Maryland, United States
Miami, Florida, United States
Louisville, Kentucky, United States
Skillman, New Jersey, United States
Khon Kaen, Tha, Thailand
Luebeck, , Germany
Salt Lake City, Utah, United States
Marburg, , Germany
Seattle, Washington, United States
Birmingham, Alabama, United States
Nashik, Maharashtra, India
Pembroke Pines, Florida, United States
Smolensk, , Russian Federation
Owensboro, Kentucky, United States
Gottingen, , Germany
Kingston, Ontario, Canada
Muenchen, , Germany
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Shanghai, , China
Plainfield, Indiana, United States
Pulau Pinang, , Malaysia
Birmingham, Alabama, United States
Merzig, , Germany
Oxford, , United Kingdom
Miami, Florida, United States
Pittsburgh, Pennsylvania, United States
Leander, Texas, United States
Berlin, , Germany
Hamburg, , Germany
Lodz, , Poland
Topolcany, , Slovakia
New Delhi, Delhi, India
Ho Chi Minh, , Vietnam
Warrensburg, Missouri, United States
Baltimore, Maryland, United States
Penang, , Malaysia
Tianjin, , China
Poznan, , Poland
Halle S, , Germany
Hanoi, , Vietnam
Quebec, , Canada
Dublin, Ohio, United States
Halle, , Germany
Linz, Oberoesterreich, Austria
Shenyang, Liaoning, China
Ahmedabad, Gujarat, India
Bad Bentheim, , Germany
Chang Chun, Jilin, China
Wilayah Persekutuan, , Malaysia
Kuala Lumpur, Mys, Malaysia
Kuala Lumpur, Selangor Darul Ehsan, Malaysia
Troy, Michigan, United States
Copenhagen Nv, , Denmark
Ryazan, , Russian Federation
Ahmedabad, Gujarat, India
Bangkoknoi, Bangkok, Thailand
Svidnik, , Slovakia
North Miami Beach, Florida, United States
Ipoh, Perak, Malaysia
Langenau, , Germany
Greenfield, Wisconsin, United States
Birmingham, Alabama, United States
Pittsburgh, Pennsylvania, United States
Mysore, Karnataka, India
St Petersburg, , Russian Federation
Stavropol, , Russian Federation
Litchfield Park, Arizona, United States
White Marsh, Maryland, United States
Sao Bernardo Do Campo, Sp, Brazil
Bialystok, , Poland
Dehradun, Uttarakhand, India
Kezmarok, , Slovakia
Kosice, Slovak Republic, Slovakia
Bramsche, , Germany
Edmonton, Alberta, Canada
Fredericton, New Brunswick, Canada
London, Ontario, Canada
Niagara Falls, Ontario, Canada
Verdun, Quebec, Canada
Murfreesboro, Tennessee, United States
Cape Town, Zaf, South Africa
Hellerup, , Denmark
Litchfield Park, Arizona, United States
Mayfield Heights, Ohio, United States
Boise, Idaho, United States
Halle (Saale), , Germany
North Charleston, South Carolina, United States
Toronto, Ontario, Canada
Cape Town, , South Africa
Bangkok, Phayathai, Thailand
Ottawa, Ontario, Canada
Wuxi, Jiangsu, China
St Petersburg, , Russian Federation
Grove City, Ohio, United States
Nashik, Maharashtra, India
Tampa, Florida, United States
Guangdong, Guangzhou, China
Shanyang, , China
Seattle, Washington, United States
San Antonio, Texas, United States
Kolkata, West Bengal, India
Edmonton, Alberta, Canada
Farmington, Connecticut, United States
North Miami Beach, Florida, United States
Plainfield, Indiana, United States
Yi Wu, Zhejiang, China
Bangalore, Karnataka, India
Kolkata, West Bengal, India
Surat, , India
Muar, , Malaysia
St Petersburg, , Russian Federation
Pretoria, Gauteng, South Africa
Zuerich, , Switzerland
Edmonton, Alberta, Canada
Bialystok, , Poland
Lodz, , Poland
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
White Marsh, Maryland, United States
Tampa, Florida, United States
Muar, Johor, Malaysia
High Point, North Carolina, United States
Pembroke Pines, Florida, United States
High Point, North Carolina, United States
San Antonio, Texas, United States
Wuhan, Hubei, China
Nagpur, Maharashtra, India
Owensboro, Kentucky, United States
Oklahoma City, Oklahoma, United States
Greenfield, Wisconsin, United States
Birmingham, Alabama, United States
Litchfield Park, Arizona, United States
Farmington, Connecticut, United States
Miami, Florida, United States
River Forest, Illinois, United States
Baltimore, Maryland, United States
Little Silver, New Jersey, United States
North Charleston, South Carolina, United States
Seattle, Washington, United States
Troy, Michigan, United States
Glenview, Illinois, United States
Glenview, Illinois, United States
Little Rock, Arkansas, United States
Farmington, Connecticut, United States
Tampa, Florida, United States
Baltimore, Maryland, United States
Missoula, Montana, United States
Dublin, Ohio, United States
San Antonio, Texas, United States
Owensboro, Kentucky, United States
Dublin, Ohio, United States
Owensboro, Kentucky, United States
Pittsburgh, Pennsylvania, United States
Little Rock, Arkansas, United States
Glenview, Illinois, United States
Halle Saale, , Germany
North Miami Beach, Florida, United States
Savannah, Georgia, United States
Greenfield, Wisconsin, United States
Taichung, , Taiwan
Cape Town, Western Province, South Africa
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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