What is the mechanism of action of this treatment?

The most common treatments for Chronic Urticaria (CU) include antihistamines, which block H1 receptors to reduce itching and swelling, and immunosuppressants like cyclosporine, which dampen the immune response. Dupilumab, a newer treatment, inhibits IL-4 and IL-13 signaling, crucial cytokines in the inflammatory pathway. This is particularly important for CU patients as it addresses the underlying immune dysregulation, offering relief for those who do not respond to antihistamines alone. By targeting specific immune pathways, these treatments can more effectively manage symptoms and improve quality of life for CU patients.

What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria include antihistamines, corticosteroids, and biologics like omalizumab and dupilumab. Dupilumab, which inhibits IL-4 and IL-13 signaling, is generally well-tolerated but can cause side effects such as injection site reactions, conjunctivitis, and eosinophilia. Omalizumab, another biologic, may cause injection site reactions, headaches, and, rarely, anaphylaxis. Corticosteroids can lead to weight gain, hypertension, and increased risk of infections with long-term use. Antihistamines are usually well-tolerated but can cause drowsiness and dry mouth.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Urticaria, particularly for cases that are resistant to antihistamines. Omalizumab, an anti-IgE monoclonal antibody, is one such treatment that has been approved for Chronic Spontaneous Urticaria (CSU). It works by binding to IgE and preventing it from attaching to mast cells and basophils, thereby reducing the release of histamine and other inflammatory mediators. While Dupilumab, which inhibits IL-4 and IL-13 signaling, is being studied for its efficacy in CSU, it has not yet received FDA approval for this specific indication. However, it is approved for other conditions like atopic dermatitis and asthma, which involve similar inflammatory pathways.

What other types of research exist?

Promising novel alternatives to Dupilumab for Chronic Urticaria patients include Janus kinase (JAK) inhibitors such as Ruxolitinib and Baricitinib, which have shown efficacy in other dermatological conditions like alopecia areata and psoriasis. Additionally, anti-IL-17 and anti-IL-23 monoclonal antibodies like Secukinumab and Guselkumab, which are used in psoriasis, may also be considered as potential alternatives.

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Monoclonal Antibodies

Dupilumab for Chronic Hives

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.

Must not have

Underlying etiology for chronic urticarias other than CSU.

Participants with a diagnosis of chronic inducible cold urticaria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 and week 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My chronic hives are not caused by chronic spontaneous urticaria.

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I have been diagnosed with chronic cold-triggered hives.

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I do not have active TB or a history of untreated TB.

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I have previously participated in a dupilumab study or used it.

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I might have or am at high risk for a parasitic infection inside my body.

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I have active Alzheimer's disease.

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I have skin conditions that could affect the study's results.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concentration of dupilumab in serum over time including Ctrough at Week 12 and Week 24

Secondary study objectives

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

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/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

~11960

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Urticaria (CU) include antihistamines, which block H1 receptors to reduce itching and swelling, and immunosuppressants like cyclosporine, which dampen the immune response. Dupilumab, a newer treatment, inhibits IL-4 and IL-13 signaling, crucial cytokines in the inflammatory pathway. This is particularly important for CU patients as it addresses the underlying immune dysregulation, offering relief for those who do not respond to antihistamines alone. By targeting specific immune pathways, these treatments can more effectively manage symptoms and improve quality of life for CU patients.