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

Last updated: April 9, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Urticaria

Treatment

placebo

LOU064 (blinded)

Clinical Study ID

NCT05677451
CLOU064F12301
2022-502159-78
2022-502159-78-00
  • Ages 12-17
  • All Genders

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 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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: placebo
Phase: 3
Study Start date:
July 11, 2023
Estimated Completion Date:
March 30, 2032

Study Description

This trial consists of 3 different periods:

  1. the "core period", which is randomized and double-blind, during which 2/3 participants will receive remibrutinib and 1/3 will receive placebo for 24 weeks. Total duration: approximately 32 weeks (10 site visits).

  2. an optional "open-label extension (OLE) period" proposed to all participants who completed 24 weeks of treatment of the "core period" and all scheduled assessments planned at week 24 visit . Depending on their CSU symptoms (as assessed by the doctor), participants will either receive remibrutinib for 24 weeks, or enter an observational treatment-free period for 1 year. If the CSU symptoms return during the observational period, the participants can switch to the treatment period at any time (decided by the doctor). At the end of the 24-week treatment period, if CSU is controlled, participants will enter the 1-year observational period, otherwise, they can continue with another cycle of 24-week remibrutinib treatment. The number of remibrutinib treatment or observational cycles will be limited to 6 times each. Total duration: from 1 year to approximately 3 years, and number of visits: from 3 to 15 (depending on the CSU symptoms).

  3. an optional "long-term treatment-free follow-up period" proposed to all participants who completed at least 4 months treatment in the "OLE period". No treatment will be given. Duration: 3 years with 1 site visit and up to 4 phone call follow-up visits.

The primary clinical question of interest is what is the effect of remibrutinib treatment versus placebo on the change from baseline in UAS7, ISS7 and HSS7 scores after 12 weeks of treatment

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1425BEN
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Santiago, 8420383
    Chile

    Site Not Available

  • Novartis Investigative Site

    Guangdong, Guangzhou 510091
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Novartis Investigative Site

    Beijing, 100069
    China

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Muenster, 48149
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Novartis Investigative Site

    Pokfulam,
    Hong Kong

    Active - Recruiting

  • Novartis Investigative Site

    Shatin, HONGKONG
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Firenze, FI 50139
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Parma, PR 43126
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Pavia, PV 27100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Siena, SI 53100
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Trieste, TS 34137
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Bari, 70126
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Napoli, 80138
    Italy

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  • Novartis Investigative Site

    Kitakyushu, Fukuoka 807-8556
    Japan

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  • Novartis Investigative Site

    Kamimashi-gun, Kumamoto 861-3106
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sakai, Osaka 593-8324
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Izumo-city, Shimane 693 8501
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Itabashi-ku, Tokyo 173-8610
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Deventer, 7416 SE
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Utrecht, 3584
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Lodz, 90-436
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Olsztyn, 10-045
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Warszawa, 02-962
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, 229899
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Pretoria, Gauteng 0009
    South Africa

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  • Novartis Investigative Site

    Cape Town, Western Cape 7405
    South Africa

    Active - Recruiting

  • Novartis Investigative Site

    Esplugues De Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46014
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Bangkoknoi, Bangkok 10700
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Songkhla, Hat Yai 90110
    Thailand

    Active - Recruiting

  • Novartis Investigative Site

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Novartis Investigative Site

    Adana, 01050
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Peterborough, Cambridgeshire PE3 9GZ
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Kern Research

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California 92123
    United States

    Active - Recruiting

  • Pediatric Dermatology of Miami at the Pediatric CoE

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Endeavor Health

    Glenview, Illinois 60077
    United States

    Active - Recruiting

  • Northshore University Health System

    Glenview, Illinois 60077
    United States

    Active - Recruiting

  • Northshore University Health System .

    Glenview, Illinois 60077
    United States

    Active - Recruiting

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Allergy and Asthma Specialist P S C Main Center

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Allergy and Asthma Specialist, P.S.C. Main Center

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • Toledo Institute of Clinical Research

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Allergy Asthma and Clinical Research

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Allergy and Clinical Immunology Ass

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Active - Recruiting

  • Novartis Investigative Site

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • RFSA Dermatology

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Allergy Associates of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • Allergy Associates of Utah

    Sandy, Utah 84093
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Seattle, Washington 98115
    United States

    Site Not Available

  • Seattle Allergy and Asthma Rsch

    Seattle, Washington 98115
    United States

    Site Not Available

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