Actively Recruiting
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Led by Novartis Pharmaceuticals · Updated on 2026-05-04
44
Participants Needed
17
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).
CONDITIONS
Official Title
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to participation
- Male or female aged 18 years or older at consent
- Confirmed diagnosis of Chronic Inducible Urticaria (CINDU) lasting at least 4 months with inadequate control by H1-antihistamines
- Symptomatic for most bothersome symptom with a score of 3 or more on the Urticaria Symptom Daily Diary for CINDU patients
- Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled with H1-antihistamines for at least 4 weeks prior to randomization
- CSU patients must have UAS7 score ≥ 16 and HSS7 score ≥ 8 in the 7 days before randomization
- CSU duration of at least 6 months
- Willing and able to attend study procedures and visits
You will not qualify if you...
- Familial or hereditary forms of CINDU
- Other diseases causing urticaria or angioedema such as urticarial vasculitis, mastocytosis, food allergies causing urticaria, or hereditary/acquired angioedema
- Significant presence of CSU symptoms in CINDU patients
- Relevant inducible urticaria trigger in CSU patients
- Other skin diseases causing chronic itching or wheals without itch that may affect study results
- Ongoing or chronic infections including HIV, Hepatitis B or C
- Major surgery within 8 weeks prior or planned during study
- Significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal diseases, or immunodeficiency impacting safety or study adherence
- Uncontrolled asthma, inflammatory bowel disease, or diseases treated with corticosteroids
- History of lymphoproliferative disease or malignancy within 5 years (with some exceptions)
- Impaired renal or hepatic function
- Abnormal hematology parameters
- Use of other investigational drugs recently
- Hypersensitivity to remibrutinib or related drugs
- Use of prohibited therapies including other BTK inhibitors within 4 months
- Recent live vaccines
- Requirement for certain anticoagulant or antiplatelet medications beyond specified exceptions
- History of significant bleeding or coagulation disorders
- Known alcohol or drug abuse within 6 months
- Pregnant or nursing women
- Women of childbearing potential not using highly effective contraception or not sterile as defined
- Local regulations for contraception if stricter than study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Actively Recruiting
2
Endeavor Health
Glenview, Illinois, United States, 60077
Actively Recruiting
3
Novartis Investigative Site
Grenoble, France, 38043
Actively Recruiting
4
Novartis Investigative Site
Montpellier, France, 34295
Actively Recruiting
5
Novartis Investigative Site
Paris, France, 75970
Actively Recruiting
6
Novartis Investigative Site
Pierre-Bénite, France, 69495
Actively Recruiting
7
Novartis Investigative Site
Dresden, Saxony, Germany, 01307
Actively Recruiting
8
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
9
Novartis Investigative Site
Mainz, Germany, 55131
Withdrawn
10
Novartis Investigative Site
Tübingen, Germany, 72076
Actively Recruiting
11
Novartis Investigative Site
Poznan, Poland, 61-731
Actively Recruiting
12
Novartis Investigative Site
Rzeszów, Poland, 35 055
Actively Recruiting
13
Novartis Investigative Site
Warsaw, Poland, 02-962
Actively Recruiting
14
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
15
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
16
Novartis Investigative Site
Alicante, Spain, 03010
Actively Recruiting
17
Novartis Investigative Site
Madrid, Spain, 28006
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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