Actively Recruiting
A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
Led by Novartis Pharmaceuticals · Updated on 2026-06-05
100
Participants Needed
66
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, how the body processes the drug, and safety of remibrutinib compared to a placebo in adolescents aged 12 to less than 18 years with chronic spontaneous urticaria not well controlled by H1-antihistamines. The study also aims to collect long-term data on the drug's safety, tolerability, and effectiveness after 24 weeks of treatment and monitor safety up to three years after the last dose. The trial includes three periods: a 24-week double-blind, randomized core period where two-thirds of participants receive remibrutinib orally twice daily and one-third receive placebo, followed by an optional open-label extension where participants who completed the core period may receive remibrutinib for up to six cycles of 24 weeks or enter a treatment-free observational period for up to one year, with options to switch based on symptoms. A further optional long-term treatment-free follow-up lasts up to three years with limited visits. Participants will have about 10 site visits during the core period and between 3 and 15 visits during the extension depending on symptoms, plus annual follow-up visits and phone calls during the long-term follow-up. Researchers will assess changes in urticaria activity and severity scores at baseline and week 12, monitor drug levels in the blood, track adverse events, and evaluate quality of life. Safety and symptom control are closely monitored throughout all study periods.
CONDITIONS
Brief Title
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adolescents aged 12 to less than 18 years at the time of informed consent
- Chronic spontaneous urticaria lasting at least 6 months before screening
- Diagnosis of chronic spontaneous urticaria not controlled by second-generation H1-antihistamines
- Presence of itch and hives for 6 or more consecutive weeks before screening despite H1-antihistamine use
- UAS7 score of 16 or higher, ISS7 score of 6 or higher, and HSS7 score of 6 or higher during the 7 days before randomization
- Documented hives within 3 months before randomization
You will not qualify if you...
- Previous use of remibrutinib or other BTK inhibitors
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding
- Requirement for anti-platelet medication other than low-dose aspirin (up to 100 mg/day) or clopidogrel (up to 75 mg/day); dual anti-platelet therapy prohibited
- History or current liver disease
- Significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological, gastrointestinal disorders or immunodeficiency that may affect safety or study compliance
- History of hypersensitivity to study drugs or similar compounds
- Predominant or sole trigger of chronic urticaria (chronic inducible urticaria) such as dermographism, cold, heat, solar, pressure, aquagenic, cholinergic, or contact urticaria
- Other diseases with urticaria or angioedema symptoms including urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria
- Other skin diseases with chronic itching that may affect study results, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either the study drug remibrutinib or placebo orally twice daily in a double-blind manner for 24 weeks during the core period.
10 site visits over approximately 32 weeks
Duration - From 1 year to approximately 3 years
Participants who complete the core period may enter an optional open-label extension where they receive remibrutinib orally twice daily for up to six cycles of 24 weeks each, or undergo observational treatment-free periods depending on their symptoms.
3 to 15 visits depending on symptoms
Duration - 3 years
Participants who complete at least 4 months of treatment in the open-label extension may enter an optional long-term treatment-free follow-up period with no treatment given.
1 site visit and up to 4 phone call follow-up visits
Trial Site Locations
Total: 66 locations
1
Kern Research
Bakersfield, California, United States, 93301
Actively Recruiting
2
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States, 92123
Actively Recruiting
3
Pediatric Dermatology of Miami at the Pediatric CoE
Miami, Florida, United States, 33156
Actively Recruiting
4
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Active, Not Recruiting
5
Endeavor Health
Glenview, Illinois, United States, 60077
Active, Not Recruiting
6
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States, 42301
Actively Recruiting
7
Toledo Institute of Clinical Research
Toledo, Ohio, United States, 43617
Active, Not Recruiting
8
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
9
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States, 15241
Active, Not Recruiting
10
RFSA Dermatology
San Antonio, Texas, United States, 78213
Actively Recruiting
11
Allergy Associates of Utah
Sandy City, Utah, United States, 84093
Completed
12
Seattle Allergy and Asthma Rsch
Seattle, Washington, United States, 98115
Withdrawn
13
Novartis Investigative Site
CABA, Buenos Aires, Argentina, 1280
Actively Recruiting
14
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1414AIF
Active, Not Recruiting
15
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEN
Actively Recruiting
16
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
17
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, S2000JKR
Actively Recruiting
18
Novartis Investigative Site
CABA, Argentina, C1181ACH
Active, Not Recruiting
19
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Active, Not Recruiting
20
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
21
Novartis Investigative Site
Santiago, Santiago Metropolitan, Chile, 8420383
Active, Not Recruiting
22
Novartis Investigative Site
Guangzhou, Guangdong, China, 510091
Active, Not Recruiting
23
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Active, Not Recruiting
24
Novartis Investigative Site
Beijing, China, 100050
Actively Recruiting
25
Novartis Investigative Site
Beijing, China, 100069
Active, Not Recruiting
26
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60590
Active, Not Recruiting
27
Novartis Investigative Site
Berlin, Germany, 13353
Completed
28
Novartis Investigative Site
Mainz, Germany, 55131
Withdrawn
29
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
30
Novartis Investigative Site
Tübingen, Germany, 72076
Completed
31
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
32
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Active, Not Recruiting
33
Novartis Investigative Site
Bari, BA, Italy, 70126
Actively Recruiting
34
Novartis Investigative Site
Florence, FI, Italy, 50139
Active, Not Recruiting
35
Novartis Investigative Site
Parma, PR, Italy, 43126
Active, Not Recruiting
36
Novartis Investigative Site
Pavia, PV, Italy, 27100
Active, Not Recruiting
37
Novartis Investigative Site
Siena, SI, Italy, 53100
Active, Not Recruiting
38
Novartis Investigative Site
Trieste, TS, Italy, 34137
Actively Recruiting
39
Novartis Investigative Site
Naples, Italy, 80138
Actively Recruiting
40
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 8078556
Active, Not Recruiting
41
Novartis Investigative Site
Kamimashi-gun, Kumamoto, Japan, 861-3106
Active, Not Recruiting
42
Novartis Investigative Site
Sakai, Osaka, Japan, 5938324
Active, Not Recruiting
43
Novartis Investigative Site
Izumo, Shimane, Japan, 6938501
Active, Not Recruiting
44
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 1738610
Completed
45
Novartis Investigative Site
Kuching, Sarawak, Malaysia, 93586
Active, Not Recruiting
46
Novartis Investigative Site
Deventer, Overijssel, Netherlands, 7416 SE
Withdrawn
47
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Active, Not Recruiting
48
Novartis Investigative Site
Lodz, Poland, 90-436
Active, Not Recruiting
49
Novartis Investigative Site
Olsztyn, Poland, 10-045
Withdrawn
50
Novartis Investigative Site
Warsaw, Poland, 02-962
Withdrawn
51
Novartis Investigative Site
Singapore, Singapore, 119074
Withdrawn
52
Novartis Investigative Site
Singapore, Singapore, 229899
Withdrawn
53
Novartis Investigative Site
Pretoria, Gauteng, South Africa, 0181
Active, Not Recruiting
54
Novartis Investigative Site
Cape Town, South Africa, 7925
Active, Not Recruiting
55
Novartis Investigative Site
Esplugues, Barcelona, Spain, 08950
Active, Not Recruiting
56
Novartis Investigative Site
Barcelona, Spain, 08035
Withdrawn
57
Novartis Investigative Site
Valencia, Spain, 46014
Active, Not Recruiting
58
Novartis Investigative Site
Songkhla, Hat Yai, Thailand, 90110
Active, Not Recruiting
59
Novartis Investigative Site
Bangkok, Thailand, 10330
Active, Not Recruiting
60
Novartis Investigative Site
Bangkok, Thailand, 10700
Active, Not Recruiting
61
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34093
Active, Not Recruiting
62
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
Active, Not Recruiting
63
Novartis Investigative Site
Adana, Turkey (Türkiye), 01330
Active, Not Recruiting
64
Novartis Investigative Site
Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
Active, Not Recruiting
65
Novartis Investigative Site
Manchester, United Kingdom, M13 9WL
Active, Not Recruiting
66
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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