A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
NCT ID: NCT05032157
Last Updated: 2025-04-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2021-12-01
2024-01-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
NCT05030311
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.
NCT06042478
A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines
NCT05048342
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
NCT06865651
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
NCT05976243
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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, locally label approved dose of a second generation H1 AH (background therapy) throughout the entire study (starting a minimum of 7 days prior to randomization until the end of the study). To treat unbearable symptoms of CSU, patients were allowed to use another second generation H1-AH on an as-needed basis (rescue therapy). Eligible patients were randomly assigned to the treatment arms in a 2:1 ratio to remibrutinib or placebo arm (300 in the remibrutinib arm and 150 in placebo arm) and stratified based on prior exposure to anti-IgE biologics for CSU and geographic region.
An extension Phase IIIb study, CLOU064A2303B (NCT05513001), was initiated to allow CLOU064A2302 eligible patients to roll over after completion of the open-label treatment period.
There were two distinct testing strategies (scenario 1 with Weekly Urticaria Activity Score (UAS7) as the primary efficacy endpoint and scenario 2 with Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) as the co-primary efficacy endpoints) based on two primary objective scenarios related to regional regulatory precedent and Health Authorities' feedback.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LOU064 25mg b.i.d.
LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open- label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)
LOU064 (blinded)
LOU064 (blinded) active treatment
LOU064 (open-label)
LOU064 (open-label) active treatment
Placebo
LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)
Placebo
Placebo
LOU064 (open-label)
LOU064 (open-label) active treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LOU064 (blinded)
LOU064 (blinded) active treatment
Placebo
Placebo
LOU064 (open-label)
LOU064 (open-label) active treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Little Rock Allergy and Asthma Clnc
Little Rock, Arkansas, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States
UCONN Health Dermatology
Farmington, Connecticut, United States
Miami Dade Medical Research
Miami, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Riverchase Dermatology
Pembroke Pines, Florida, United States
TrueBlue Clinical Research
Tampa, Florida, United States
AeroAllergy Research Laboratories of Savannah Inc
Savannah, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Northshore University Health System
Glenview, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States
John Hopkins University
Baltimore, Maryland, United States
Chesapeake Clinical Research
White Marsh, Maryland, United States
Revival Research Institute
Troy, Michigan, United States
Montana Medical Research
Missoula, Montana, United States
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States
Peters Medical Research
High Point, North Carolina, United States
CR Services Acquisition US
Dublin, Ohio, United States
Ohio Clinical Research Associates
Mayfield Heights, Ohio, United States
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
STAAMP Research LLC
San Antonio, Texas, United States
Intermountain Clinical Research
Salt Lake City, Utah, United States
Seattle Allergy and Asthma Rsch
Seattle, Washington, United States
Allergy Asthma and amp Sinus Ctr S C
Greenfield, Wisconsin, United States
Novartis Investigative Site
Linz, Upper Austria, Austria
Novartis Investigative Site
São Bernardo do Campo, São Paulo, Brazil
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Fredericton, New Brunswick, Canada
Novartis Investigative Site
Kingston, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Niagara Falls, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Verdun, Quebec, Canada
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangdong, Guangzhou, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Yiwu, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Copenhagen NV, , Denmark
Novartis Investigative Site
Hellerup, , Denmark
Novartis Investigative Site
Bad Bentheim, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bramsche, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Halle S, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Langenau, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Lübeck, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Marburg, , Germany
Novartis Investigative Site
Merzig, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Ahmedabad, Gujarat, India
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Mysore, Karnataka, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nashik, Maharashtra, India
Novartis Investigative Site
Dehradun, Uttarakhand, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
New Delhi, , India
Novartis Investigative Site
Surat, , India
Novartis Investigative Site
Muar town, Johor, Malaysia
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Novartis Investigative Site
Ipoh, Perak, Malaysia
Novartis Investigative Site
Pulau Pinang, , Malaysia
Novartis Investigative Site
Wilayah Persekutuan, , Malaysia
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Ryazan, , Russia
Novartis Investigative Site
Ryazan, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Stavropol, , Russia
Novartis Investigative Site
Kežmarok, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigative Site
Svidník, , Slovakia
Novartis Investigative Site
Topoľčany, , Slovakia
Novartis Investigative Site
Pretoria, Gauteng, South Africa
Novartis Investigative Site
Cape Town, Western Province, South Africa
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
Novartis Investigative Site
Bangkoknoi, Bangkok, Thailand
Novartis Investigative Site
Khon Kaen, THA, Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
Cardiff, , United Kingdom
Novartis Investigative Site
Oxford, , United Kingdom
Novartis Investigative Site
Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Metz M, Gimenez-Arnau A, Hide M, Lebwohl M, Mosnaim G, Saini S, Sussman G, Szalewski R, Haemmerle S, Lheritier K, Martzloff ED, Seko N, Wang P, Zharkov A, Maurer M; REMIX-1 and REMIX-2 Investigators; REMIX-1 Investigators; REMIX-2 Investigators. Remibrutinib in Chronic Spontaneous Urticaria. N Engl J Med. 2025 Mar 6;392(10):984-994. doi: 10.1056/NEJMoa2408792.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-000424-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLOU064A2302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.