Clinical Trials in Poland / NCT05677451
Active, not recruiting Phase 3

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

NCT05677451 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2023-07-11
Last updated
2026-07-20

Condition(s) studied

Chronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

LOU064 (blinded) →placebo

LOU064 (blinded): LOU064 (blinded) active treatment

placebo: matching active drug

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
Key Inclusion Criteria: * Male and female adolescent participants aged \>= 12 to \< 18 years of age at the time of signing the informed consent * 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-AH 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-AH during this time period according to local treatment 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 screening and/or at randomization; or documented in the participants' medical history) 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 100 mg/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 of the study results or otherwise preclude participation or protocol adherence of the participant * History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes * Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria * Other diseases with symptoms of urticaria or angioedema, including but not limited to 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 the investigator'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.

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Kern Research Bakersfield California
Allergy and Asthma Medical Group and Research Center San Diego California
Pediatric Dermatology of Miami at the Pediatric CoE Miami Florida
Treasure Valley Medical Research Boise Idaho
Endeavor Health Glenview Illinois
Allergy and Asthma Specialist P S C Owensboro Kentucky
Toledo Institute of Clinical Research Toledo Ohio
Allergy Asthma and Clinical Research Oklahoma City Oklahoma
Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania
RFSA Dermatology San Antonio Texas
Allergy Associates of Utah Sandy City Utah
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Rosario Santa Fe Province
Novartis Investigative Site CABA Argentina
Novartis Investigative Site San Miguel de Tucumán Argentina
Novartis Investigative Site Montreal Quebec
Novartis Investigative Site Santiago Santiago Metropolitan
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Chengdu Sichuan
Novartis Investigative Site Beijing China
Novartis Investigative Site Beijing China
Novartis Investigative Site Frankfurt am Main Hesse
Novartis Investigative Site Berlin Germany
Novartis Investigative Site Tübingen Germany
Novartis Investigative Site Hong Kong Hong Kong
Novartis Investigative Site Hong Kong Hong Kong
Novartis Investigative Site Florence FI
Novartis Investigative Site Pavia PV
Novartis Investigative Site Siena SI
Novartis Investigative Site Kitakyushu Fukuoka
Novartis Investigative Site Kamimashi-gun Kumamoto
Novartis Investigative Site Sakai Osaka
Novartis Investigative Site Izumo Shimane
Novartis Investigative Site Itabashi-ku Tokyo
Novartis Investigative Site Kuching Sarawak
Novartis Investigative Site Utrecht Netherlands
Novartis Investigative Site Lodz Poland
Novartis Investigative Site Pretoria Gauteng
Novartis Investigative Site Cape Town South Africa
Novartis Investigative Site Esplugues Barcelona

+ 10 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05677451 on ClinicalTrials.gov ↗ ← All trials in Poland