New shot could stop cold hives

NCT ID NCT04681729

Completed Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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.