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Monoclonal Antibodies

Dupilumab for Chronic Hives

Q: 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.

Q: 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.

Q: 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.

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Participant must be ≥ 2 years to <12 years of age, at the time of signing the informed consent.

Body weight within ≥5 kg to <60 kg.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 24

Awards & highlights

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.

Who is the study for?

This trial is for children aged 2 to less than 12 with Chronic Spontaneous Urticaria (CSU) who still have symptoms despite taking H1-antihistamines. They must weigh between ≥5 kg and <60 kg, and be able to follow the study procedures. Kids with a history of cancer in the last 5 years, current serious infections or immunodeficiency, previous dupilumab use, certain types of urticaria, hypersensitivity to dupilumab, risk of parasitic infection, tuberculosis or severe skin conditions other than CSU cannot join.Check my eligibility

What is being tested?

The study tests Dupilumab's effects on kids with uncontrolled CSU over a period of 24 weeks. It will assess how the drug moves through their bodies (pharmacokinetics) and its safety profile during treatment and up until a follow-up at week 38-40 after six scheduled visits.See study design

What are the potential side effects?

While not specified here, common side effects from Dupilumab may include injection site reactions like redness or swelling, eye issues such as dryness or irritation, cold sores in your mouth or throat area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 11 years old.

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My body weight is between 5 kg and 60 kg.

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I have chronic hives for over 6 weeks and still have symptoms despite taking antihistamines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 and week 24

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

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

OLE Period: Dupilumab/Dupilumab

OLE Period: Placebo/Dupilumab

DB Period: Dupilumab

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,956 Total Patients Enrolled

3 Trials studying Chronic Urticaria

630 Patients Enrolled for Chronic Urticaria

Regeneron PharmaceuticalsIndustry Sponsor

620 Previous Clinical Trials

380,441 Total Patients Enrolled

1 Trials studying Chronic Urticaria

397 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