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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

Abroad (travel likely)RecruitingPHASE3

Conditions

Chronic Spontaneous Urticaria

Simple summaryAI-assisted

This summary is produced by a language model and is experimental. It may be incomplete or inaccurate and is not a substitute for professional medical advice.

Locations

  • Kern Research, Bakersfield, California, United States

    Contact: Study coordinator (Wandy Noriega) · wandy.noriega@kernresearch.com · 661-864-7710
    Contact: Principal Investigator (Eric Boren)

  • Allergy and Asthma Medical Group and Research Center, San Diego, California, United States

    Contact: Study coordinator (Susan Smith) · susansmith@allergyandasthma.com · 858-268-2368
    Contact: Principal Investigator (Bob Geng)

  • Pediatric Dermatology of Miami at the Pediatric CoE, Miami, Florida, United States

    Contact: Study coordinator (Andrea Marin) · andrea@pediatricskinresearch.com · 305-667-3152
    Contact: Principal Investigator (Mercedes E Gonzalez)

  • Treasure Valley Medical Research, Boise, Idaho, United States

  • Endeavor Health, Glenview, Illinois, United States

  • Allergy and Asthma Specialist P S C, Owensboro, Kentucky, United States

    Contact: Study coordinator (Angela Haynes) · ahaynes@cloremd.com · 270-684-6144
    Contact: Principal Investigator (Lee Clore)

  • Toledo Institute of Clinical Research, Toledo, Ohio, United States

  • Allergy Asthma and Clinical Research, Oklahoma City, Oklahoma, United States

    Contact: Study coordinator (Meryem Assaoui) · meryem@mtarpay.com · 405-752-0393
    Contact: Principal Investigator (Martha Tarpay)

  • Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania, United States

  • RFSA Dermatology, San Antonio, Texas, United States

    Contact: Study coordinator (Jonathan Joseph) · jvjoseph007@gmail.com
    Contact: Principal Investigator (Lindsey Finklea)

  • Allergy Associates of Utah, Sandy City, Utah, United States

  • Seattle Allergy and Asthma Rsch, Seattle, Washington, United States

  • Novartis Investigative Site, CABA, Buenos Aires, Argentina

  • Novartis Investigative Site, CABA, Buenos Aires, Argentina

  • Novartis Investigative Site, Caba, Buenos Aires, Argentina

  • Novartis Investigative Site, Rosario, Santa Fe Province, Argentina

  • Novartis Investigative Site, Rosario, Santa Fe Province, Argentina

  • Novartis Investigative Site, CABA, Argentina

  • Novartis Investigative Site, San Miguel de Tucumán, Argentina

  • Novartis Investigative Site, Montreal, Quebec, Canada

  • Novartis Investigative Site, Santiago, Santiago Metropolitan, Chile

  • Novartis Investigative Site, Guangzhou, Guangdong, China

  • Novartis Investigative Site, Chengdu, Sichuan, China

  • Novartis Investigative Site, Beijing, China

  • Novartis Investigative Site, Beijing, China

  • Novartis Investigative Site, Frankfurt am Main, Hesse, Germany

  • Novartis Investigative Site, Berlin, Germany

  • Novartis Investigative Site, Mainz, Germany

  • Novartis Investigative Site, Münster, Germany

  • Novartis Investigative Site, Tübingen, Germany

  • Novartis Investigative Site, Hong Kong, Hong Kong

  • Novartis Investigative Site, Hong Kong, Hong Kong

  • Novartis Investigative Site, Bari, BA, Italy

  • Novartis Investigative Site, Florence, FI, Italy

  • Novartis Investigative Site, Parma, PR, Italy

  • Novartis Investigative Site, Pavia, PV, Italy

  • Novartis Investigative Site, Siena, SI, Italy

  • Novartis Investigative Site, Trieste, TS, Italy

  • Novartis Investigative Site, Naples, Italy

  • Novartis Investigative Site, Kitakyushu, Fukuoka, Japan

  • Novartis Investigative Site, Kamimashi-gun, Kumamoto, Japan

  • Novartis Investigative Site, Sakai, Osaka, Japan

  • Novartis Investigative Site, Izumo, Shimane, Japan

  • Novartis Investigative Site, Itabashi-ku, Tokyo, Japan

  • Novartis Investigative Site, Kuching, Sarawak, Malaysia

  • Novartis Investigative Site, Deventer, Overijssel, Netherlands

  • Novartis Investigative Site, Utrecht, Netherlands

  • Novartis Investigative Site, Lodz, Poland

  • Novartis Investigative Site, Olsztyn, Poland

  • Novartis Investigative Site, Warsaw, Poland

  • Novartis Investigative Site, Singapore, Singapore

  • Novartis Investigative Site, Singapore, Singapore

  • Novartis Investigative Site, Pretoria, Gauteng, South Africa

  • Novartis Investigative Site, Cape Town, South Africa

  • Novartis Investigative Site, Esplugues, Barcelona, Spain

  • Novartis Investigative Site, Barcelona, Spain

  • Novartis Investigative Site, Valencia, Spain

  • Novartis Investigative Site, Songkhla, Hat Yai, Thailand

  • Novartis Investigative Site, Bangkok, Thailand

  • Novartis Investigative Site, Bangkok, Thailand

  • Novartis Investigative Site, Istanbul, Fatih, Turkey (Türkiye)

  • Novartis Investigative Site, Ankara, Sihhiye-Altindag, Turkey (Türkiye)

  • Novartis Investigative Site, Adana, Turkey (Türkiye)

  • Novartis Investigative Site, Peterborough, Cambridgeshire, United Kingdom

  • Novartis Investigative Site, Manchester, United Kingdom

  • Novartis Investigative Site, Southampton, United Kingdom

Study leads

  • Novartis Pharmaceuticals

    Study Director

    Novartis Pharmaceuticals

View source on ClinicalTrials.gov(opens in a new tab)