Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-05
100
Participants Needed
65
Research Sites
455 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment
CONDITIONS
Official 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...
- Adolescents aged 12 to under 18 years at consent
- Chronic spontaneous urticaria lasting at least 6 months before screening
- CSU not controlled by second-generation H1-antihistamines with symptoms of itch and hives for at least 6 consecutive weeks
- 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
- Documentation of hives within 3 months before randomization
You will not qualify if you...
- Previous use of remibrutinib or other BTK inhibitors
- Significant bleeding risk or blood clotting disorders
- History of gastrointestinal bleeding
- Need for anti-platelet medication except aspirin up to 100 mg/day or clopidogrel up to 75 mg/day; dual anti-platelet therapy is not allowed
- History or current liver disease
- Significant cardiovascular, neurological, psychiatric, lung, kidney, liver, endocrine, metabolic, blood, gastrointestinal, or immune disorders that affect safety or study participation
- Allergy to study drugs or similar medications
- Predominant or sole trigger for urticaria (chronic inducible urticaria) or other specific types of urticaria
- Other diseases causing urticaria or angioedema
- Other skin diseases causing chronic itching that may affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 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
Actively 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
Actively 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
Actively Recruiting
19
Novartis Investigative Site
San Miguel de Tucumán, Argentina, 4000
Actively 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
Actively Recruiting
23
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
24
Novartis Investigative Site
Beijing, China, 100050
Actively Recruiting
25
Novartis Investigative Site
Beijing, China, 100069
Actively Recruiting
26
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
27
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
28
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
29
Novartis Investigative Site
Münster, Germany, 48149
Actively Recruiting
30
Novartis Investigative Site
Tübingen, Germany, 72076
Actively Recruiting
31
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
32
Novartis Investigative Site
Bari, BA, Italy, 70126
Actively Recruiting
33
Novartis Investigative Site
Florence, FI, Italy, 50139
Actively Recruiting
34
Novartis Investigative Site
Parma, PR, Italy, 43126
Actively Recruiting
35
Novartis Investigative Site
Pavia, PV, Italy, 27100
Actively Recruiting
36
Novartis Investigative Site
Siena, SI, Italy, 53100
Actively Recruiting
37
Novartis Investigative Site
Trieste, TS, Italy, 34137
Actively Recruiting
38
Novartis Investigative Site
Naples, Italy, 80138
Actively Recruiting
39
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 8078556
Actively Recruiting
40
Novartis Investigative Site
Kamimashi-gun, Kumamoto, Japan, 861-3106
Actively Recruiting
41
Novartis Investigative Site
Sakai, Osaka, Japan, 5938324
Actively Recruiting
42
Novartis Investigative Site
Izumo, Shimane, Japan, 6938501
Actively Recruiting
43
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 1738610
Actively Recruiting
44
Novartis Investigative Site
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
45
Novartis Investigative Site
Deventer, Overijssel, Netherlands, 7416 SE
Actively Recruiting
46
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Actively Recruiting
47
Novartis Investigative Site
Lodz, Poland, 90-436
Actively Recruiting
48
Novartis Investigative Site
Olsztyn, Poland, 10-045
Actively Recruiting
49
Novartis Investigative Site
Warsaw, Poland, 02-962
Actively Recruiting
50
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
51
Novartis Investigative Site
Singapore, Singapore, 229899
Actively Recruiting
52
Novartis Investigative Site
Pretoria, Gauteng, South Africa, 0181
Actively Recruiting
53
Novartis Investigative Site
Cape Town, South Africa, 7925
Actively Recruiting
54
Novartis Investigative Site
Esplugues, Barcelona, Spain, 08950
Actively Recruiting
55
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
56
Novartis Investigative Site
Valencia, Spain, 46014
Actively Recruiting
57
Novartis Investigative Site
Songkhla, Hat Yai, Thailand, 90110
Actively Recruiting
58
Novartis Investigative Site
Bangkok, Thailand, 10330
Actively Recruiting
59
Novartis Investigative Site
Bangkok, Thailand, 10700
Actively Recruiting
60
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34093
Actively Recruiting
61
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
Actively Recruiting
62
Novartis Investigative Site
Adana, Turkey (Türkiye), 01330
Actively Recruiting
63
Novartis Investigative Site
Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
Actively Recruiting
64
Novartis Investigative Site
Manchester, United Kingdom, M13 9WL
Actively Recruiting
65
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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