Dupilumab for Chronic Hives

Recruiting at 34 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called dupilumab in children with chronic spontaneous urticaria (CSU) who do not improve with regular allergy medicines. The study aims to see if dupilumab is safe and how it behaves in the body over several months. Dupilumab helps by blocking proteins that cause inflammation, reducing symptoms. Dupilumab is approved in the United States for the treatment of moderate-to-severe atopic dermatitis in adults and children aged 6 and up, demonstrating rapid and sustained efficacy.

Eligibility Criteria

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.

Inclusion Criteria

Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.

I am between 2 and 11 years old.

My body weight is between 5 kg and 60 kg.

Exclusion Criteria

Known or suspected immunodeficiency.

I am not currently on antibiotics, antivirals, or antifungals for an infection.

My chronic hives are not caused by chronic spontaneous urticaria.

Treatment Details

Interventions

• Dupilumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Dupilumab Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School