Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)

NCT ID: NCT04681729

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2023-04-20

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 of an H1-antihistamine

Secondary Objectives:

To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease control To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU local signs and symptoms (hives/wheals, itch, burning sensation and pain) after provocation test To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease activity To demonstrate improvement in health-related quality-of-life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of participants who require rescue therapy To evaluate the proportion of participants with cold exposure triggered urticaria To evaluate safety outcome measures To evaluate immunogenicity of dupilumab

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.

Conditions

Cold Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dupilumab

Dose regimens, on top of regular or as needed non-sedating H1-antihistamine

Group Type: EXPERIMENTAL

Dupilumab SAR231893

Intervention Type: DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Non sedating H1-antihistamine

Intervention Type: DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Matched Placebo

Placebo, on top of regular/as needed non-sedating H1-antihistamine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Non sedating H1-antihistamine

Intervention Type: DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Interventions

Dupilumab SAR231893

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Intervention Type: DRUG

Non sedating H1-antihistamine

Pharmaceutical form: Tablet Route of administration: Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Allergy and Asthma Medical Group and Research Center-Site Number:8400001

San Diego, California, United States

Treasure Valley Medical Research-Site Number:8400007

Boise, Idaho, United States

Allergy & Asthma Specialists, PSC-Site Number:8400003

Owensboro, Kentucky, United States

Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400005

Baltimore, Maryland, United States

Bernstein Allergy Group Inc-Site Number:8400004

Cincinnati, Ohio, United States

Investigational Site Number :0320001

CABA, Buenos Aires, Argentina

Investigational Site Number :0320005

CABA, Buenos Aires, Argentina

Investigational Site Number :0320006

CABA, Buenos Aires, Argentina

Investigational Site Number :0320002

Rosario, Santa Fe Province, Argentina

Investigational Site Number :0320004

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number :0320003

Buenos Aires, , Argentina

Investigational Site Number :1240008

Edmonton, Alberta, Canada

Investigational Site Number :1240010

Edmonton, Alberta, Canada

Investigational Site Number :1240007

Hamilton, Ontario, Canada

Investigational Site Number :1240009

Hamilton, Ontario, Canada

Investigational Site Number :1240001

Toronto, Ontario, Canada

Investigational Site Number :1240011

Montreal, Quebec, Canada

Investigational Site Number :1240005

Saint-Charles-Borromée, Quebec, Canada

Investigational Site Number :1240006

Sherbrooke, Quebec, Canada

Investigational Site Number :1240002

Québec, , Canada

Investigational Site Number :2760002

Berlin, , Germany

Investigational Site Number :2760004

Dresden, , Germany

Investigational Site Number :2760007

Erlangen, , Germany

Investigational Site Number :2760006

Hanover, , Germany

Investigational Site Number :2760005

Leipzig, , Germany

Investigational Site Number :2760001

Mainz, , Germany

Investigational Site Number :3920002

Nagoya, Aichi-ken, Japan

Investigational Site Number :3920003

Hiroshima, Hiroshima, Japan

Investigational Site Number :3920008

Kamimashiki Gun, Kumamoto, Japan

Investigational Site Number :3920007

Sakai-shi, Osaka, Japan

Investigational Site Number :3920010

Koto-ku, Tokyo, Japan

Investigational Site Number :3920011

Tachikawa-shi, Tokyo, Japan

Investigational Site Number :3920009

Habikino-Shi, , Japan

Countries

United States; Argentina; Canada; Germany; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25251&tenant=MT_SNY_9011

EFC16720 Plain Language Results Summary

Other Identifiers

2020-003756-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1246-6913

Identifier Type: REGISTRY

Identifier Source: secondary_id

EFC16720

Identifier Type: -

Identifier Source: org_study_id