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)
NCT ID: NCT04180488
Last Updated: 2025-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
397 participants
INTERVENTIONAL
2019-12-11
2024-10-25
Brief Summary
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This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders)
Secondary Objectives:
This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Study A Dupilumab
Participants who were omalizumab naïve received dupilumab for 24 weeks as follows:
* 300 milligrams (mg) SC injection every 2 weeks (q2w) for adults and those adolescents who weighed \>=60 kilograms (kg) at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1,
* 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and
* 300 mg SC injection every 4 weeks (q4w) for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Study A Placebo
Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks.
Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Study B Dupilumab
Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows:
* 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or
* 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1.
Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Study B Placebo
Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.
Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Study C Dupilumab
Participants who were omalizumab naïve received dupilumab for 24 weeks as follows:
* 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1,
* 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and
* 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1.
Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Study C Placebo
Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks.
Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Interventions
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Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Eligibility Criteria
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Inclusion Criteria
* Study B: Participant were ≥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 had 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 that time period
* Used 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 were willing and able to complete a daily symptom e-Diary for the duration of the study
Exclusion Criteria
* Weight was 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
* Presented 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 have adversely affected the participant'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 participant's potential participation in a clinical trial.
6 Years
80 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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California Allergy and Asthma Medical Group, Inc. Site Number : 8400019
Los Angeles, California, United States
Sarasota Clinical Research Site Number : 8400017
Sarasota, Florida, United States
Lenus Research & Medical Group Site Number : 8400001
Sweetwater, Florida, United States
University of South Florida Site Number : 8400006
Tampa, Florida, United States
Aeroallergy Research Laboratories of Savannah, INC Site Number : 8400018
Savannah, Georgia, United States
Allergy & Asthma Specialists, PSC Site Number : 8400020
Owensboro, Kentucky, United States
Johns Hopkins University (Asthma and Allergy Center) Site Number : 8400016
Baltimore, Maryland, United States
The Clinical Research Center, LLC Site Number : 8400009
St Louis, Missouri, United States
UR Dermatology at College Town Site Number : 8400008
Rochester, New York, United States
Immunocarolina LLC Site Number : 8400010
Charlotte, North Carolina, United States
Bernstein Clinical Research Center Site Number : 8400014
Cincinnati, Ohio, United States
Vital Prospects Clinical Research Institute, P.C. Site Number : 8400015
Tulsa, Oklahoma, United States
Allergy and Clinical Immunology Associates Site Number : 8400024
Pittsburgh, Pennsylvania, United States
National Allergy and ENT Site Number : 8400011
Charleston, South Carolina, United States
Pharmaceutical Research & Consulting, Inc. Site Number : 8400003
Dallas, Texas, United States
STAAMP Research, LLC Site Number : 8400007
San Antonio, Texas, United States
Investigational Site Number : 0320008
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320004
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320005
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 1240009
Calgary, Alberta, Canada
Investigational Site Number : 1240010
Edmonton, Alberta, Canada
Investigational Site Number : 1240014
Hamilton, Ontario, Canada
Investigational Site Number : 1240013
Markham, Ontario, Canada
Investigational Site Number : 1240003
Niagara Falls, Ontario, Canada
Investigational Site Number : 1240005
Toronto, Ontario, Canada
Investigational Site Number : 1240002
Toronto, Ontario, Canada
Investigational Site Number : 1240007
Windsor, Ontario, Canada
Investigational Site Number : 1240016
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240006
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1240004
Québec, , Canada
Investigational Site Number : 1240011
Québec, , Canada
Investigational Site Number : 1560010
Beijing, , China
Investigational Site Number : 1560004
Beijing, , China
Investigational Site Number : 1560001
Chengdu, , China
Investigational Site Number : 1560007
Guangzhou, , China
Investigational Site Number : 1560002
Hangzhou, , China
Investigational Site Number : 1560008
Hangzhou, , China
Investigational Site Number : 1560006
Jinan, , China
Investigational Site Number : 1560003
Shanghai, , China
Investigational Site Number : 1560005
Wuxi, , China
Investigational Site Number : 2500009
Calais, , France
Investigational Site Number : 2500002
Lille, , France
Investigational Site Number : 2500011
Mont-de-Marsan, , France
Investigational Site Number : 2500004
Nantes, , France
Investigational Site Number : 2500012
Nice, , France
Investigational Site Number : 2500003
Nice, , France
Investigational Site Number : 2500006
Paris, , France
Investigational Site Number : 2500005
Pierre-Bénite, , France
Investigational Site Number : 2760001
Berlin, , Germany
Investigational Site Number : 2760010
Bramsche, , Germany
Investigational Site Number : 2760006
Dresden, , Germany
Investigational Site Number : 2760007
Kiel, , Germany
Investigational Site Number : 2760008
Tübingen, , Germany
Investigational Site Number : 3480005
Debrecen, , Hungary
Investigational Site Number : 3480004
Szeged, , Hungary
Investigational Site Number : 3480003
Szolnok, , Hungary
Investigational Site Number : 3480002
Szombathely, , Hungary
Investigational Site Number : 3920005
Hiroshima, Hiroshima, Japan
Investigational Site Number : 3920009
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920002
Kobe, Hyōgo, Japan
Investigational Site Number : 3920011
Kagoshima, Kagoshima-ken, Japan
Investigational Site Number : 3920013
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920008
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920003
Suita-shi, Osaka, Japan
Investigational Site Number : 3920007
Izumo-shi, Shimane, Japan
Investigational Site Number : 3920006
Itabashi-ku, Tokyo, Japan
Investigational Site Number : 3920001
Shinagawa-Ku, Tokyo, Japan
Investigational Site Number : 3920010
Tachikawa-shi, Tokyo, Japan
Investigational Site Number : 3920004
Nagoya, , Japan
Investigational Site Number : 6430008
Chelyabinsk, , Russia
Investigational Site Number : 6430006
Kazan', , Russia
Investigational Site Number : 6430007
Krasnodar, , Russia
Investigational Site Number : 6430005
Moscow, , Russia
Investigational Site Number : 6430010
Moscow, , Russia
Investigational Site Number : 6430002
Moscow, , Russia
Investigational Site Number : 6430003
Saint Petersburg, , Russia
Investigational Site Number : 6430009
Saratov, , Russia
Investigational Site Number : 6430004
Smolensk, , Russia
Investigational Site Number : 6430001
Stavropol, , Russia
Investigational Site Number : 7240012
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240008
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240014
L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240010
Esplugues de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240005
Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 7240007
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240006
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240002
Pamplona, Navarre, Spain
Investigational Site Number : 7240013
Burjassot - Valencia, Valenciana, Comunidad, Spain
Investigational Site Number : 7240004
Córdoba, , Spain
Investigational Site Number : 7240011
Villarreal de Huerva, , Spain
Investigational Site Number : 8260002
London, London, City of, United Kingdom
Investigational Site Number : 8260001
Manchester, , United Kingdom
Countries
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References
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Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Laws E, Maloney J, Bauer D, Radin A, Makhija M. Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels. Dermatol Ther (Heidelb). 2024 Sep;14(9):2427-2441. doi: 10.1007/s13555-024-01231-y. Epub 2024 Jul 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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EFC16461 Plain language Results Summary
Other Identifiers
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U1111-1241-8208
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-003775-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC16461
Identifier Type: -
Identifier Source: org_study_id
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