Phase
Condition
Hives (Urticaria)
Urticaria
Treatment
placebo
LOU064 (blinded)
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male and female adolescent participants aged >= 12 to < 18 years of age at the timeof signing the informed consent
CSU duration for >= 6 months prior to screening (defined as the onset of CSUdetermined by the investigator based on all available supporting documentation)
Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time ofrandomization defined as:
The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despitethe use of second-generation H1-AH during this time period according to localtreatment guidelines
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 screeningand/or at randomization; or documented in the participants' medical history)
Exclusion
Key Exclusion criteria:
Previous use of remibrutinib or other BTK inhibitors
Significant bleeding risk or coagulation disorders
History of gastrointestinal bleeding
Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g.,acetylsalicylic acid + clopidogrel) is prohibited
History or current hepatic disease
Evidence of clinically significant cardiovascular, 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 ofthe study results or otherwise preclude participation or protocol adherence of theparticipant
History of hypersensitivity to any of the study drugs or its excipients or to drugsof similar chemical classes
Participants having a clearly defined predominant or sole trigger of their chronicurticaria (chronic inducible urticaria) including urticaria factitia (symptomaticdermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-,cholinergic-, or contact-urticaria
Other diseases with symptoms of urticaria or angioedema, including but not limitedto urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis,hereditary angioedema, or drug-induced urticaria
Any other skin disease associated with chronic itching that might influence in theinvestigator's opinion the study evaluations and results, e.g., atopic dermatitis,bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1425BEN
ArgentinaActive - Recruiting
Novartis Investigative Site
Rosario, Santa Fe 2000
ArgentinaActive - Recruiting
Novartis Investigative Site
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Novartis Investigative Site
Santiago, 8420383
ChileSite Not Available
Novartis Investigative Site
Guangdong, Guangzhou 510091
ChinaActive - Recruiting
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100069
ChinaActive - Recruiting
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Mainz, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Muenster, 48149
GermanyActive - Recruiting
Novartis Investigative Site
Tuebingen, 72076
GermanyActive - Recruiting
Novartis Investigative Site
Hong Kong, 999077
Hong KongActive - Recruiting
Novartis Investigative Site
Pokfulam,
Hong KongActive - Recruiting
Novartis Investigative Site
Shatin, HONGKONG
Hong KongSite Not Available
Novartis Investigative Site
Firenze, FI 50139
ItalyActive - Recruiting
Novartis Investigative Site
Parma, PR 43126
ItalyActive - Recruiting
Novartis Investigative Site
Pavia, PV 27100
ItalyActive - Recruiting
Novartis Investigative Site
Siena, SI 53100
ItalyActive - Recruiting
Novartis Investigative Site
Trieste, TS 34137
ItalyActive - Recruiting
Novartis Investigative Site
Bari, 70126
ItalyActive - Recruiting
Novartis Investigative Site
Napoli, 80138
ItalyActive - Recruiting
Novartis Investigative Site
Kitakyushu, Fukuoka 807-8556
JapanActive - Recruiting
Novartis Investigative Site
Kamimashi-gun, Kumamoto 861-3106
JapanActive - Recruiting
Novartis Investigative Site
Sakai, Osaka 593-8324
JapanActive - Recruiting
Novartis Investigative Site
Izumo-city, Shimane 693 8501
JapanActive - Recruiting
Novartis Investigative Site
Itabashi-ku, Tokyo 173-8610
JapanActive - Recruiting
Novartis Investigative Site
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Novartis Investigative Site
Deventer, 7416 SE
NetherlandsActive - Recruiting
Novartis Investigative Site
Utrecht, 3584
NetherlandsActive - Recruiting
Novartis Investigative Site
Lodz, 90-436
PolandActive - Recruiting
Novartis Investigative Site
Olsztyn, 10-045
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 02-962
PolandActive - Recruiting
Novartis Investigative Site
Singapore, 229899
SingaporeActive - Recruiting
Novartis Investigative Site
Pretoria, Gauteng 0009
South AfricaActive - Recruiting
Novartis Investigative Site
Cape Town, Western Cape 7405
South AfricaActive - Recruiting
Novartis Investigative Site
Esplugues De Llobregat, Barcelona 08950
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainActive - Recruiting
Novartis Investigative Site
Valencia, Comunidad Valenciana 46014
SpainActive - Recruiting
Novartis Investigative Site
Bangkoknoi, Bangkok 10700
ThailandSite Not Available
Novartis Investigative Site
Songkhla, Hat Yai 90110
ThailandActive - Recruiting
Novartis Investigative Site
Bangkok, 10700
ThailandActive - Recruiting
Novartis Investigative Site
Adana, 01050
TurkeyActive - Recruiting
Novartis Investigative Site
Ankara, 06230
TurkeyActive - Recruiting
Novartis Investigative Site
Istanbul, 34093
TurkeyActive - Recruiting
Novartis Investigative Site
Peterborough, Cambridgeshire PE3 9GZ
United KingdomActive - Recruiting
Novartis Investigative Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
Kern Research
Bakersfield, California 93301
United StatesActive - Recruiting
Allergy and Asthma Medical Group and Research Center
San Diego, California 92123
United StatesActive - Recruiting
Pediatric Dermatology of Miami at the Pediatric CoE
Coral Gables, Florida 33134
United StatesActive - Recruiting
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesActive - Recruiting
Endeavor Health
Glenview, Illinois 60077
United StatesActive - Recruiting
Northshore University Health System
Glenview, Illinois 60077
United StatesActive - Recruiting
Northshore University Health System .
Glenview, Illinois 60077
United StatesActive - Recruiting
Allergy and Asthma Specialist P S C
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Allergy and Asthma Specialist P S C Main Center
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Allergy and Asthma Specialist, P.S.C. Main Center
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Novartis Investigative Site
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Toledo Institute of Clinical Research
Toledo, Ohio 43617
United StatesActive - Recruiting
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Allergy and Clinical Immunology Ass
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
Novartis Investigative Site
San Antonio, Texas 78213
United StatesActive - Recruiting
RFSA Dermatology
San Antonio, Texas 78213
United StatesActive - Recruiting
Allergy Associates of Utah
Murray, Utah 84107
United StatesSite Not Available
Allergy Associates of Utah
Sandy, Utah 84093
United StatesActive - Recruiting
Novartis Investigative Site
Seattle, Washington 98115
United StatesSite Not Available
Seattle Allergy and Asthma Rsch
Seattle, Washington 98115
United StatesSite Not Available
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