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

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: H1-antihistamines

Must not be taking: Systemic antibiotics, antivirals

Disqualifiers: Active AD, Active TB, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must remain symptomatic despite regular H1-antihistamine treatment. This suggests you may continue taking H1-antihistamines during the trial.

What data supports the effectiveness of the drug Dupilumab for chronic hives?

Dupilumab has been shown to be effective in treating atopic dermatitis (a skin condition causing itchy and inflamed skin) and asthma, both of which involve similar inflammatory processes as chronic hives. This suggests that Dupilumab might also be beneficial for chronic hives. ^{1 2 3 4 5}

Is dupilumab generally safe for humans?

Dupilumab has been used to treat conditions like atopic dermatitis and asthma, and while it is generally considered safe, some people have experienced side effects such as eye problems, skin reactions, and allergic reactions. Most side effects are mild, but some people have stopped using it due to these issues. ^{3 6 7 8 9}

How is the drug Dupilumab different from other treatments for chronic hives?

Dupilumab is unique because it is a monoclonal antibody that targets the interleukin-4 receptor, blocking signals from proteins (IL-4 and IL-13) involved in allergic inflammation. This mechanism is different from traditional treatments for hives, which often focus on antihistamines or steroids. ^{2 3 4 7 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 to 4 weeks

Treatment

Participants receive dupilumab subcutaneously every 4 weeks or every 2 weeks for 24 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Dupilumab

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

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

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

Findings from Research

Dupixent (dupilumab) is set to receive FDA approval for asthma treatment on October 20, expanding its use beyond atopic dermatitis.

Once approved, Dupixent will be part of a group of monoclonal antibodies, including Nucala, Cinqair, and Fasenra, that target type 2 inflammation in severe asthma, highlighting its role in managing this specific asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. Reinke, T.[2019]

Dupilumab is an effective treatment for atopic dermatitis, showing significant improvements in skin symptoms and overall disease control in clinical trials.

The medication works by inhibiting specific pathways in the immune system, which helps reduce inflammation and alleviate the symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. D'Ippolito, D., Pisano, M.[2020]

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, effectively inhibiting the action of IL-4 and IL-13, which are key players in allergic diseases.

It received its first approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond well to topical treatments, and is also being developed for asthma, nasal polyps, and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. Shirley, M.[2022]

Dupilumab is the first biologic therapy approved for adults with moderate-to-severe atopic dermatitis (AD), showing significant improvements in disease severity, itching, sleep quality, and overall quality of life in phase III trials involving patients inadequately controlled by other treatments.

The treatment was well tolerated with low rates of serious side effects, making dupilumab a promising long-term option for patients with AD, especially since it maintains its benefits over a year of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. Frampton, JE., Blair, HA.[2019]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

In a study of 46 adult patients with moderate-to-severe atopic dermatitis treated with dupilumab, 34.8% experienced ocular adverse events (OAEs), primarily mild to moderate dry eye disease and superficial punctate keratitis.

Patients with pre-existing conditions such as dry eye disease, eyelid eczema, or high IgE levels were more likely to develop OAEs, suggesting that these factors should be considered before starting dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. Touhouche, AT., Cassagne, M., Bérard, E., et al.[2021]

In a study of 64 complex patients with moderate-to-severe atopic dermatitis, including the elderly and those on immunosuppressive therapies, 87.5% showed improvement or disease clearance with dupilumab, indicating its efficacy in challenging populations.

While 20.3% of patients experienced side effects, including conjunctivitis and anaphylactic reactions, only 9.4% discontinued treatment due to these effects, suggesting that dupilumab can be safely used in patients with significant co-morbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of use, efficacy, and safety of dupilumab in complex patients: a retrospective, case-series study from a large, urban academic center. Lukac, D., Pagani, K., McGee, JS.[2023]

Dupilumab, a monoclonal antibody approved by the FDA in 2017, effectively treats moderate to severe atopic dermatitis by inhibiting IL-4 and IL-13 signaling, providing an alternative for patients not responding to topical therapies.

While dupilumab is generally effective, it can cause adverse effects such as injection site reactions and conjunctivitis, with rare cases like alopecia areata reported, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab side effect in a patient with atopic dermatitis: a case report study. Albader, SS., Alharbi, AA., Alenezi, RF., et al.[2020]

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of atopic dermatitis: A clinical trial review. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Overview of use, efficacy, and safety of dupilumab in complex patients: a retrospective, case-series study from a large, urban academic center. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab side effect in a patient with atopic dermatitis: a case report study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]