Dupilumab for Chronic Hives

No longer recruiting at 37 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called dupilumab for children with chronic hives (CSU) that do not improve with regular allergy medicine. Researchers aim to determine the safety of this treatment and how it moves through the body. The trial seeks children who have experienced itchy, bumpy skin for more than six weeks, despite taking allergy medications. Participants will receive dupilumab injections for 24 weeks, with the study including several visits over 38 to 40 weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for chronic hives.

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.

Is there any evidence suggesting that dupilumab is likely to be safe for children with chronic hives?

Research has shown that dupilumab is generally safe for patients. In studies with adults and teenagers, dupilumab greatly reduced itching and hives in people with chronic spontaneous urticaria (CSU). These studies found that dupilumab eased symptoms without causing major side effects.

In another long-term study, dupilumab's safety profile for children was similar to that for adults, indicating that side effects were alike and manageable for both age groups.

Overall, research suggests that dupilumab is a safe treatment option for people with CSU. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Dupilumab is unique because it targets a specific pathway in the immune system called the IL-4 and IL-13 signaling pathways, which are involved in inflammatory responses associated with chronic hives. Unlike standard treatments like antihistamines or corticosteroids, which mainly provide symptomatic relief, Dupilumab addresses the underlying cause of the inflammation. Researchers are excited about this treatment because it offers a new mechanism of action that could potentially provide more effective and long-lasting relief for patients with chronic hives. Additionally, its administration through subcutaneous injection every two or four weeks could offer a convenient dosing schedule compared to daily or more frequent treatments.

What evidence suggests that dupilumab might be an effective treatment for chronic hives?

Research shows that Dupilumab, the investigational treatment in this trial, effectively reduces symptoms of chronic hives. Studies have found that it significantly lessens itching and the number of hives, making these symptoms less severe. For patients who haven't found relief with other treatments, Dupilumab reduced the intensity of itching and hives. Evidence suggests it could be a promising option for those still experiencing symptoms despite using H1-antihistamines. Overall, Dupilumab has demonstrated a strong ability to improve the quality of life for people with chronic spontaneous urticaria (CSU). ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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 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 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, 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]

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]

Citations

1. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-treat-chronic-spontaneous-urticaria-csu

Dupixent® (dupilumab) to Treat Chronic Spontaneous ... Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38431226/

Dupilumab in patients with chronic spontaneous urticaria ... Conclusions: Dupilumab reduced urticaria activity by reducing itch and hives severity in omalizumab-naive patients with CSU uncontrolled with H1 ...

3. sanofi.com sanofi.com/en/media-room/press-releases/2024/2024-10-24-12-00-00-2968628

Press Release: Dupixent late-breaking positive phase 3 ... Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline.

4. dupixenthcp.com dupixenthcp.com/chronic-spontaneous-urticaria/efficacy/hives-results

Hives Efficacy Results in CSU Reductiona in HSS7 at Week 12 (DUPIXENT: -5.62 vs placebo: -4.31, secondary endpoint; not significant) · Mean HSS7 at baseline: DUPIXENT (n=73): 13.31 (SD, 4.43); ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate ...

6. dupixenthcp.com dupixenthcp.com/chronic-spontaneous-urticaria/

Chronic Spontaneous Urticaria In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in ...