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)
Public ClinicalTrials.gov record NCT04180488. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04180488
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 397 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2019 (Actual)
- Primary completion
- Aug 1, 2024 (Actual)
- Completion
- Oct 25, 2024 (Actual)
- Last update posted
- Aug 20, 2025
2019 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Allergy and Asthma Medical Group, Inc. Site Number : 8400019 | Los Angeles | California | 90025 | — |
| Sarasota Clinical Research Site Number : 8400017 | Sarasota | Florida | 34239 | — |
| Lenus Research & Medical Group Site Number : 8400001 | Sweetwater | Florida | 33172 | — |
| University of South Florida Site Number : 8400006 | Tampa | Florida | 33613 | — |
| Aeroallergy Research Laboratories of Savannah, INC Site Number : 8400018 | Savannah | Georgia | 31406 | — |
| Allergy & Asthma Specialists, PSC Site Number : 8400020 | Owensboro | Kentucky | 42301 | — |
| Johns Hopkins University (Asthma and Allergy Center) Site Number : 8400016 | Baltimore | Maryland | 21224 | — |
| The Clinical Research Center, LLC Site Number : 8400009 | St Louis | Missouri | 63141 | — |
| UR Dermatology at College Town Site Number : 8400008 | Rochester | New York | 14642 | — |
| Immunocarolina LLC Site Number : 8400010 | Charlotte | North Carolina | 28277 | — |
| Bernstein Clinical Research Center Site Number : 8400014 | Cincinnati | Ohio | 45236 | — |
| Vital Prospects Clinical Research Institute, P.C. Site Number : 8400015 | Tulsa | Oklahoma | 74136 | — |
| Allergy and Clinical Immunology Associates Site Number : 8400024 | Pittsburgh | Pennsylvania | 15241 | — |
| National Allergy and ENT Site Number : 8400011 | Charleston | South Carolina | 29420 | — |
| Pharmaceutical Research & Consulting, Inc. Site Number : 8400003 | Dallas | Texas | 75231 | — |
| STAAMP Research, LLC Site Number : 8400007 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 82 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04180488, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04180488 live on ClinicalTrials.gov.