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New shot could stop cold hives

NCT ID NCT04681729

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested dupilumab, an injectable drug, in 82 people with cold urticaria (hives triggered by cold) who still had symptoms despite taking antihistamines. The goal was to see if dupilumab could prevent hives after an ice cube test and improve quality of life. Participants received either dupilumab or a placebo injection every two weeks for 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dupilumab (injection)
What this could lead to
If successful, dupilumab could offer a new treatment option for people with cold urticaria who don't get relief from antihistamines.
What could go wrong
This is a Phase 3 trial, but results may not apply to everyone. Dupilumab is an injectable drug and may have side effects like injection reactions or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

82 people

The number who actually took part.

Started

Dec 2020

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cold urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cold urticaria

Contacts and locations

Locations

  • Allergy & Asthma Specialists, PSC-Site Number:8400003

    Owensboro, Kentucky, 42301, United States

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

    San Diego, California, 92123, United States

  • Bernstein Allergy Group Inc-Site Number:8400004

    Cincinnati, Ohio, 45231, United States

  • Investigational Site Number :0320001

    CABA, Buenos Aires, C1023AAB, Argentina

  • Investigational Site Number :0320002

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number :0320003

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number :0320004

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Investigational Site Number :0320005

    CABA, Buenos Aires, C1181ACH, Argentina

  • Investigational Site Number :0320006

    CABA, Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number :1240001

    Toronto, Ontario, M3B 3S6, Canada

  • Investigational Site Number :1240002

    Québec, G1V 4W2, Canada

  • Investigational Site Number :1240005

    Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

  • Investigational Site Number :1240006

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Investigational Site Number :1240007

    Hamilton, Ontario, L8L 3C3, Canada

  • Investigational Site Number :1240008

    Edmonton, Alberta, T5J 3S9, Canada

  • Investigational Site Number :1240009

    Hamilton, Ontario, L8S1G5, Canada

  • Investigational Site Number :1240010

    Edmonton, Alberta, T6G 1C3, Canada

  • Investigational Site Number :1240011

    Montreal, Quebec, H4A 3T2, Canada

  • Investigational Site Number :2760001

    Mainz, 55131, Germany

  • Investigational Site Number :2760002

    Berlin, 10117, Germany

  • Investigational Site Number :2760004

    Dresden, 01307, Germany

  • Investigational Site Number :2760005

    Leipzig, 04103, Germany

  • Investigational Site Number :2760006

    Hanover, 30625, Germany

  • Investigational Site Number :2760007

    Erlangen, 91054, Germany

  • Investigational Site Number :3920002

    Nagoya, Aichi-ken, 454-8509, Japan

  • Investigational Site Number :3920003

    Hiroshima, Hiroshima, 734-8551, Japan

  • Investigational Site Number :3920007

    Sakai-shi, Osaka, 593-8324, Japan

  • Investigational Site Number :3920008

    Kamimashiki Gun, Kumamoto, 861-3106, Japan

  • Investigational Site Number :3920009

    Habikino-Shi, 583-0872, Japan

  • Investigational Site Number :3920010

    Koto-ku, Tokyo, 136-0074, Japan

  • Investigational Site Number :3920011

    Tachikawa-shi, Tokyo, 190-0023, Japan

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

    Baltimore, Maryland, 21224, United States

  • Treasure Valley Medical Research-Site Number:8400007

    Boise, Idaho, 83706, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.