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Monoclonal Antibodies

Non sedating H1-antihistamine for Cold Urticaria

Phase 3

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36)

Awards & highlights

Study Summary

This trial is testing the effectiveness of dupilumab on reducing symptoms of ColdU, a chronic inducible cold urticaria, in participants who remain symptomatic despite the use of an H1-antihistamine.

Eligible Conditions

Cold Urticaria

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first imp administration (day 1) up to 14 weeks after last imp administration (i.e., up to week 36) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Negative Ice Cube Provocation Test at Week 24

Secondary outcome measures

Change From Baseline in Cold Urticaria Quality of Life (ColdU-QoL) Scale Score at Week 24

Change From Baseline in Cold Urticaria Signs and Symptoms Severity Scale Score at Week 24

Change From Baseline in Health-related Quality-of-life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) Scale Scores at Week 24

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment2 Interventions

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

Group II: Matched PlaceboPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Non sedating H1-antihistamine

2020

Completed Phase 3

~90

Dupilumab SAR231893

2021

Completed Phase 4

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,161 Previous Clinical Trials

3,511,957 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

613 Previous Clinical Trials

379,676 Total Patients Enrolled

2 Trials studying Cold Urticaria

124 Patients Enrolled for Cold Urticaria

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,018,873 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any similar projects that have utilized Non sedating H1-antihistamine?

"H1-antihistamine was first explored in a 2015 clinical trial at the Regeneron Investigational Site. So far, 18296 trials have concluded with 52 more presently underway. A large number of these ongoing studies are based in Boise, Idaho."

Answered by AI

To your knowledge, is this research the initial attempt of its kind?

"Since 2015, Non sedating H1-antihistamine has been the focus of clinical research. The first study was sponsored by Sanofi in 2015 and involved 880 participants. Thanks to the data collected in this and subsequent Phase 3 trials, Non sedating H1-antihistamine received drug approval. Currently, there are 52 ongoing trials in locations as widespread as 455 cities across 43 countries."

Answered by AI

Are middle-aged adults welcome to participate in this experiment?

"Eligibility requirements for this particular trial state that participants must be between the ages of 12 and 80. Out of the 100 total trials, 27 are for individuals younger than 18 and 73 are for seniors."

Answered by AI

For what purpose is non-sedating H1-antihistamine most commonly taken?

"Non sedating H1-antihistamine can help patients manage their dermatitis, atopic, failure with corticosteroid therapy, and eosinophil."

Answered by AI

Has the government given their okay to market and sell non-drowsy H1-antihistamines?

"There is some data supporting the efficacy of non-sedating H1-antihistamines, and multiple rounds of data have shown that they are safe, so our team at Power gives them a score of 3."

Answered by AI

At how many institutions is this trial taking place?

"This study is recruiting patients from medical research sites 8400007 in Boise, Idaho, 8400003 in Owensboro, Kentucky, and 8400004 in Cincinnati, Ohio. A full list of other 18 locations can be found on the study website."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04681729.