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Evaluating LOU064 for treating chronic hives in adolescents

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

PHASE3 · Novartis · NCT05677451

This study is testing a new treatment called LOU064 to see if it can help teenagers with chronic hives who aren't getting enough relief from standard allergy medications.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment100 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionsremibrutinib
Locations65 sites (Bakersfield, California and 64 other locations)
Trial IDNCT05677451 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the efficacy, pharmacokinetics, and safety of LOU064 in adolescents aged 12 to under 18 years who suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by H1-antihistamines. The trial consists of a 24-week double-blind randomized core period where participants receive either LOU064 or a placebo, followed by an optional open-label extension period for additional treatment or observation based on symptom control. Participants will also be monitored for long-term safety and efficacy for up to three years after treatment completion.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to under 18 years with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.

Not a fit: Patients who have previously used remibrutinib or other BTK inhibitors will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of chronic spontaneous urticaria in adolescents, leading to better quality of life.

How similar studies have performed: While there have been studies on BTK inhibitors, this specific approach in adolescents with CSU is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bakersfield, California and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Spontaneous Urticaria, BTK inhibitor, Chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.