Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Launched by SANOFI · Nov 26, 2019
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
The duration of study for each participant will include 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Study A and C: Participant must be ≥6 years to 80 years of age at the time of signing the informed consent.
- • Study B: Participant must be ≥12 years (or the minimum legal age for adolescents in the country of the investigational site) to 80 years of age at the time of signing the informed consent
- • Participants who have a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by
- • Diagnosis of CSU\>6 months prior to screening visit
- • Presence of itch and hives for \>6 consecutive weeks at any time prior to screening visit despite the use of H1-AH during this time period
- • Using a study defined H1-antihistamine for CSU treatment
- * During the 7 days before randomization:
- • UAS7≥16 ISS7≥ 8
- • Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
- • Participants must be willing and able to complete a daily symptom e-Diary for the duration of the study
- Exclusion Criteria:
- Participants are excluded from any of the studies if any of the following criteria apply:
- • Weight is less than 30 kg in adults and adolescents and 15 kg in children aged 6 to\<12years
- • Clearly defined underlying etiology for chronic urticarias other than CSU
- • Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes
- • Active atopic dermatitis
- • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
- • Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
- • Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
- • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period
- • Known or suspected immunodeficiency
- • Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
- • History of systemic hypersensitivity or anaphylaxis to omalizumab or any biologic therapy, including any excipients
- • Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
- • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pamplona, Navarra, Spain
Lille, , France
Buenos Aires, , Argentina
Quebec, , Canada
Chengdu, , China
Los Angeles, California, United States
Sarasota, Florida, United States
Sweetwater, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
San Miguel De Tucuman, Tucumán, Argentina
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Trois Rivieres, Quebec, Canada
Beijing, , China
Guangzhou, , China
Hangzhou, , China
Hangzhou, , China
Jinan, , China
Shanghai, , China
Wuxi, , China
Nantes, , France
Nice, , France
Paris Cedex 20, , France
Pierre Benite, , France
Berlin, , Germany
Dresden, , Germany
Kiel, , Germany
Debrecen, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Hiroshima Shi, Hiroshima, Japan
Kobe Shi, Hyogo, Japan
Yokohama Shi, Kanagawa, Japan
Suita Shi, Osaka, Japan
Izumo Shi, Shimane, Japan
Itabashi Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Tachikawa Shi, Tokyo, Japan
Nagoya Shi, , Japan
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Krasnodar, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Saratov, , Russian Federation
Smolensk, , Russian Federation
St Petersburg, , Russian Federation
Stavropol, , Russian Federation
Barcelona, Barcelona [Barcelona], Spain
Barcelona, Barcelona [Barcelona], Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Córdoba, , Spain
Málaga, , Spain
London, London, City Of, United Kingdom
Manchester, , United Kingdom
Lille, , France
Sapporo Shi, Hokkaido, Japan
Debrecen, , Hungary
Cincinnati, Ohio, United States
Nagoya Shi, Aichi, Japan
Los Angeles, California, United States
Sarasota, Florida, United States
Sweetwater, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Tulsa, Oklahoma, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
Niagara Falls, Ontario, Canada
Sherbrooke, Quebec, Canada
Verdun, Quebec, Canada
Quebec, , Canada
Beijing, , China
Ars Laquenexy, , France
Paris, , France
Valence, , France
Kagoshima Shi, Kagoshima, Japan
Santiago De Compostela, A Coruña [La Coruña], Spain
Esplugues De Llobregat, Catalunya [Cataluña], Spain
Burjassot Valencia, Valenciana, Comunidad, Spain
Villareal, , Spain
Langenau, , Germany
Tübingen, , Germany
Hospitalet De Llobregat, Barcelona [Barcelona], Spain
Chengdu, , China
Shanghai, , China
Lille, , France
Pierre Benite, , France
Cincinnati, Ohio, United States
Caba, Buenos Aires, Argentina
Madrid, Madrid, Comunidad De, Spain
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Pamplona, Navarra, Spain
San Miguel De Tucuman, , Argentina
Los Angeles, California, United States
Sarasota, Florida, United States
Sweetwater, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Tulsa, Oklahoma, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
San Miguel De Tucuman, Tucumán, Argentina
Buenos Aires, , Argentina
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
Niagara Falls, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Sherbrooke, Quebec, Canada
Trois Rivieres, Quebec, Canada
Verdun, Quebec, Canada
Quebec, , Canada
Quebec, , Canada
Beijing, , China
Beijing, , China
Guangzhou, , China
Hangzhou, , China
Hangzhou, , China
Jinan, , China
Wuxi, , China
Ars Laquenexy, , France
Calais, , France
Mont De Marsan, , France
Nantes, , France
Nice, , France
Paris, , France
Valence, , France
Berlin, , Germany
Bramsche, , Germany
Dresden, , Germany
Kiel, , Germany
Langenau, , Germany
Tübingen, , Germany
Debrecen, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Hiroshima Shi, Hiroshima, Japan
Sapporo Shi, Hokkaido, Japan
Kobe Shi, Hyogo, Japan
Kagoshima Shi, Kagoshima, Japan
Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Suita Shi, Osaka, Japan
Izumo Shi, Shimane, Japan
Itabashi Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Tachikawa Shi, Tokyo, Japan
Nagoya Shi, , Japan
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Krasnodar, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Saratov, , Russian Federation
Smolensk, , Russian Federation
St Petersburg, , Russian Federation
Stavropol, , Russian Federation
Santiago De Compostela, A Coruña [La Coruña], Spain
Barcelona, Barcelona [Barcelona], Spain
Barcelona, Barcelona [Barcelona], Spain
Hospitalet De Llobregat, Barcelona [Barcelona], Spain
Esplugues De Llobregat, Catalunya [Cataluña], Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Burjassot Valencia, Valenciana, Comunidad, Spain
Córdoba, , Spain
Málaga, , Spain
Villareal, , Spain
London, London, City Of, United Kingdom
Manchester, , United Kingdom
Madrid, , Spain
Nice, , France
Pittsburgh, Pennsylvania, United States
Nice, , France
Santiago De Compostela, , Spain
Barcelona, , Spain
Barcelona, , Spain
Hospitalet De Llobregat, , Spain
Esplugues De Llobregat, , Spain
Madrid, , Spain
Madrid, , Spain
Burjassot Valencia, , Spain
London, , United Kingdom
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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