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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria

In brief

Primary Objective: 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

Key facts

Study ID

NCT04180488

Run by

Sanofi

People needed

397

Starts

2019-12-11

Expected to finish

2024-10-25

Last updated by the study team

2025-08-20

Who can join

Age: 6 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study A and C: Participant were ≥6 years to 80 years of age at the time of signing the informed consent.
• 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

You may not qualify if…

• Participants were excluded from any of the studies if any of the following criteria apply:
• 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.

Where it is running

• 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
• California Allergy and Asthma Medical Group, Inc. Site Number : 8400019 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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