Dupixent for Itchiness

Overseen By Jessica Kracker, BSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Akron Children's Hospital

Must not be taking: Dupixent, Steroids

Disqualifiers: Pregnancy, Cancer, Kidney disease, others

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: 12 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Dupixent (dupilumab) to determine its effectiveness in reducing itching for individuals with itchy scars from burns. Participants will receive either Dupixent or a placebo (a treatment with no active drug) to compare its effectiveness against current standard treatments like antihistamines. It suits individuals who continue to experience itchiness despite current treatments and have had skin grafts after burns. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking steroids or Dupixent for another condition.

Is there any evidence suggesting that Dupixent is likely to be safe for humans?

Previous studies have shown that dupilumab is safe. Research indicates that people with moderate-to-severe atopic dermatitis, a skin condition, generally tolerate it well. Most report only mild side effects, such as dry eyes or mild skin reactions at the injection site. Another study demonstrated its safety even for individuals with other conditions, like prurigo nodularis, a skin disease causing hard, itchy bumps.

These findings suggest that dupilumab could be a safe option for those considering participation in a clinical trial for this medication. However, discussing potential risks and benefits with a healthcare provider remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for itchiness focus on topical creams or antihistamines, but Dupixent works differently by targeting a specific pathway in the immune system. It uses dupilumab, a monoclonal antibody that blocks the action of interleukin-4 and interleukin-13, both of which play a key role in causing inflammation and itchiness. This targeted approach can potentially offer more effective relief for patients who have not responded well to standard treatments. Researchers are excited because Dupixent's novel mechanism of action could lead to significant improvements in managing persistent itchiness.

What evidence suggests that Dupixent might be an effective treatment for post-burn itching?

Research has shown that Dupixent (dupilumab), which participants in this trial may receive, can help reduce itching. In one study, 41% of adults using Dupixent experienced a significant decrease in itchiness, compared to only 12% of those taking a placebo. Another study found that 83% of patients felt less itchy within four weeks of starting Dupixent. By week 24, 58.8% of patients reported a noticeable improvement in their itch. These findings suggest that Dupixent might be an effective option for easing itchiness after a burn. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with post-burn hypertrophic scars that were treated with grafting. Participants should have ongoing itchiness not relieved by standard treatments like antihistamines and neuroleptics, at least four weeks after their last surgery, and must speak English well enough to participate.

Inclusion Criteria

I am 18-60 years old with itchy scars from burns treated with grafting, and treatments haven't helped.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six injections of Dupixent or placebo over 12 weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The study tests Dupixent's effectiveness in relieving persistent itching in burn patients compared to a placebo. It aims to see if Dupixent can improve symptoms better than the usual care involving medications such as antihistamines.

How Is the Trial Designed?

Group I: ARM 1 - Dupixent Active Control 1 Intervention

Two subcutaneous injection of 300mg Dupixent at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two 300 mg doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.

Group II: ARM 2 - Placebo Placebo Group 1 Intervention

Two subcutaneous injection of the placebo at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.

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?

Akron Children's Hospital

Lead Sponsor

Trials

50

Recruited

5,009,000+

Ohio State University Wexner Medical Center

Collaborator

Trials

3

Recruited

620+

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

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

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]

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]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

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]

Patients treated with Dupilumab showed a higher risk of contracting COVID-19, but the infections were generally less severe, suggesting that Dupilumab may have a protective effect against severe disease.

The analysis included data from the WHO global pharmacovigilance database, identifying 109 COVID-19 cases among Dupilumab users, indicating a need for further research to clarify the immunological mechanisms behind these observations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher rates of COVID-19 but less severe infections reported for patients on Dupilumab: a Big Data analysis of the World Health Organization VigiBase. Mahroum, N., Damiani, G., Watad, A., et al.[2022]

Dupilumab is effective and generally well tolerated for treating moderate to severe atopic dermatitis, but patients may experience ocular surface disease more frequently compared to those on placebo.

Real-world data have identified some previously unreported adverse events, such as blood eosinophilia and rosacea-like skin lesions, indicating the need for further long-term studies to clarify their relationship with dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of dupilumab in patients with atopic dermatitis: expert opinion. Francuzik, W., Alexiou, A., Worm, M.[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]

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. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/pruritus-nrs-clinical-trial

Adult Peak Pruritus NRS Efficacy Results 41 % of adults treated with DUPIXENT (n=213) achieved ≥4-point reduction in Peak Pruritus NRS vs 12% with placebo at Week 16 in SOLO 1 (n=212; P<0.001)

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35569006/

Efficacy of dupilumab in chronic prurigo and ... Ninety patients out of 109 (83%) noticed an improvement in pruritus before 4 weeks of dupilumab therapy. At the end of treatment, 18 patients out of 126 (14%) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666328724000683

Dupilumab improves pruritus and skin lesions in patients ... At week 24, 90 (58.8%) dupilumab-treated vs 30 (19.0%) placebo-treated patients achieved clinically meaningful improvement in itch, 71 (46.4%) vs 27 (17.1%) ...

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

Itch Efficacy Results in CSU | DUPIXENT® (dupilumab) Psoriasis: Cases of new-onset psoriasis have been reported with the use of DUPIXENT for the treatment of atopic dermatitis and asthma, including in patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11651321/

Fast Itch Relief during Dupilumab Predicts Clinical Efficacy in ... A total of 8/12 patients (67%) had complete response, and 4/12 patients (33%) had partial response during dupilumab treatment. Notably, a highly significant ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9895771/

Dupilumab for the treatment of prurigo nodularis Dupilumab has been shown to be safer and more effective in controlling patients with PN in combination with other underlying diseases, even HIV infection or ...

8. annallergy.org annallergy.org/article/S1081-1206(25)00203-0/fulltext

Patient outcomes and safety of combination biologic ... 1. A 56-y-old man saw significant eczema improvement within 3 mo of adding dupilumab, discontinued corticosteroids, and reported dry eyes. 2. A ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04417894

NCT04417894 | A Study to Evaluate the Efficacy and ... The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis.

10. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data

Sanofi and Regeneron Report Positive Proof-of-Concept ... Treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms ...