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Monoclonal Antibodies

Dupilumab for Chronic Urticaria

Investigational Site Number :1240006, Winnipeg, Canada
DupilumabPhase 3RecruitingResearch Sponsored by Sanofi

Study Summary

This trial is a study to test the safety and effectiveness of a new medication for children with chronic hives who remain symptomatic despite other treatments. The study will last 38-40 weeks and there will be 8 study visits.

Eligible Conditions
  • Chronic Urticaria

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have been diagnosed with chronic spontaneous urticaria (CSU) or have been experiencing symptoms of CSU for at least 3 months, according to the doctor.
Select...
You have hives that itch and swell for more than 6 weeks despite taking regular antihistamine medication.
Select...
Your weight is between 5 and 60 kilograms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24
Secondary outcome measures
Change from baseline in Children's Dermatology Quality Life Index (C-DLQI) in children from 4 years to less than 12 years of age at Week 24
Change from baseline in Infants' Dermatitis Quality of Life Index (IDQOL) in children from 2 years to less than 4 years of age at Week 24
Change from baseline in the modified Hive Severity Score over 7 days (HSS7) at Week 24
+4 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
12%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Administered subcutaneously (SC) every 4 weeks (Q4W) or every 2 weeks (Q2W) with or without an initial loading dose based on weight and age
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,129 Previous Clinical Trials
3,107,840 Total Patients Enrolled
3 Trials studying Chronic Urticaria
617 Patients Enrolled for Chronic Urticaria
Regeneron PharmaceuticalsIndustry Sponsor
592 Previous Clinical Trials
360,581 Total Patients Enrolled
1 Trials studying Chronic Urticaria
384 Patients Enrolled for Chronic Urticaria

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05526521 — Phase 3
Chronic Urticaria Research Study Groups: Dupilumab
Chronic Urticaria Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05526521 — Phase 3
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05526521 — Phase 3

Frequently Asked Questions

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

Has the FDA given Dupilumab the green light?

"Dupilumab has received a safety score of 3. This is due to the fact that it is a Phase 3 trial, which means that there is available data which supports its efficacy as well as its safety from multiple rounds of testing."

Answered by AI

Are people being recruited for this research right now?

"Yes, the clinicaltrials.gov website shows that this trial is actively recruiting patients. The listing was first posted on August 25th, 2022 and updated on October 26th, 2022."

Answered by AI

Does this research project allow individuals that are over the age of 50 to participate?

"Children aged 2 to 11 can participate in this clinical trial. There are 8 similar trials for younger patients and 34 for senior citizens."

Answered by AI
~12 spots leftby Mar 2025