Status:
COMPLETED
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Cold Urticaria
Eligibility:
All Genders
12-80 years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use ...
Detailed Description
The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.
Eligibility Criteria
Inclusion
- Participant had to be ≥12 years to 80 years of age inclusive at the time of signing the informed consent
- Participants who had a diagnosis of primary acquired chronic inducible ColdU defined as recurrence of itchy wheals and/or angioedema due to cold for longer than 6 weeks prior to screening visit (Visit 1)
- Participants with positive ice cube provocation test, ie, presenting at least a confluent hive/wheal on the exposed skin area, at the screening visit (Visit 1) and randomization visit (Visit 2)
- Participants meeting at least 1 of the following criteria despite regular/daily or as needed use of H1-antihistamine (AH):
- Urticaria Control Test (UCT) (4 item) \<12 at the screening visit (Visit 1) and randomization visit (Visit 2)
- Within 6 months prior to the screening visit, documented medical history of cold exposure triggered anaphylaxis or oropharyngeal edema
- Within 6 months prior to the screening visit, documented medical history of cold exposure triggered urticaria requiring emergency medical care visit or treatment with epinephrine
- Participants using a study defined H1-antihistamine regularly/daily or as needed for primary acquired chronic inducible cold urticaria
- Body weight ≥30 kg
Exclusion
- Participants were excluded from the study if any of the following criteria applied:
- Clearly defined underlying etiology for urticaria other than primary acquired chronic inducible ColdU
- Presence of skin morbidities other than cold urticaria 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 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 any other biologic therapy or any of its excipients.
- Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
- The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04681729
Start Date
December 10 2020
End Date
April 20 2023
Last Update
September 10 2025
Active Locations (33)
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1
Allergy and Asthma Medical Group and Research Center-Site Number:8400001
San Diego, California, United States, 92123
2
Treasure Valley Medical Research-Site Number:8400007
Boise, Idaho, United States, 83706
3
Allergy & Asthma Specialists, PSC-Site Number:8400003
Owensboro, Kentucky, United States, 42301
4
Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400005
Baltimore, Maryland, United States, 21224