Dupilumab for Atopic Dermatitis

Overseen By Nicole Nechiporchik

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must be taking: Dupilumab

Must not be taking: Antibiotics, Antivirals, Antiparasitics, Antifungals

Disqualifiers: Asthma, COPD, Infections, Cancer, others

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

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: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how patients from different ethnic backgrounds respond to dupilumab, a medication for atopic dermatitis (AD), which causes red and itchy patches. It aims to understand differences in inflammatory reactions among Caucasian, Asian, and African American patients. Participants should have experienced moderate-to-severe AD for at least two years, affecting more than 10% of their body. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a cutaneous infection or are taking certain antibiotics, antivirals, antiparasitics, or antifungals, you may need to wait before joining the trial.

What is the safety track record for dupilumab?

Research has shown that dupilumab is generally safe for individuals with atopic dermatitis (AD). One study found that adults using only dupilumab, without other treatments, did not experience major safety issues. Another study involving younger patients, aged 6 to 18, also confirmed the safety of dupilumab for this age group.

When combined with topical corticosteroids (creams or ointments that reduce skin inflammation), patients with moderate to severe AD responded well and did not encounter any unexpected side effects.

Overall, these findings suggest that dupilumab is a safe treatment option for people with AD. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets and blocks the activity of certain proteins involved in the inflammatory process of atopic dermatitis, specifically interleukin-4 (IL-4) and interleukin-13 (IL-13). Unlike standard treatments like topical corticosteroids and calcineurin inhibitors, which mainly address surface symptoms, Dupilumab works at a deeper, immunological level to reduce inflammation. Researchers are excited about Dupilumab because it offers a targeted approach, potentially leading to better control of symptoms and improved skin health for those with atopic dermatitis.

What is the effectiveness track record for dupilumab in treating atopic dermatitis?

Research has shown that dupilumab effectively treats moderate-to-severe atopic dermatitis (AD). One study found that dupilumab quickly reduces harmful skin inflammation by blocking certain signals in the body. Another study demonstrated that dupilumab improves skin condition and reduces itching in adults with AD. Various studies have also shown that it is safe and effective over the long term. This treatment is already approved for AD, proving its effectiveness for many patients. ^{4 6 7 8 9}

Who Is on the Research Team?

Johann Gudjonsson, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe eczema (AD) covering more than 10% of their body. They must have had AD for at least two years and agree to use contraception or abstain from sex if they can have children. People with recent severe asthma, immune issues, certain infections including COVID-19, a history of cancer (except some skin cancers), substance abuse, or those on other trials can't join.

Inclusion Criteria

My skin condition affects more than 10% of my body and is moderately to severely bad.

Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol

I have been diagnosed with atopic dermatitis for over 2 years.

Exclusion Criteria

I have a history of poor wound healing or keloid formation.

I have or might have had COVID-19 in the last 4 weeks.

I haven't had cancer, except for specific skin or cervical cancers, in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab to assess differences in inflammatory responses among ethnic groups

12 weeks

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 how different ethnic groups (Caucasian, Asian, African American) respond to Dupilumab for treating eczema. It explores whether ethnicity affects inflammation and response to the drug that blocks a specific part of the immune system involved in allergic reactions.

How Is the Trial Designed?

Group I: Dupilumab Experimental Treatment 1 Intervention

The 3 groups of patients (Asian, African American, and Caucasian) will all receive the same intervention.

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?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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 review of 22 studies involving 3303 patients, dupilumab demonstrated significant efficacy in treating atopic dermatitis, with 85.1% of patients achieving at least a 50% improvement in their Eczema Area and Severity Index (EASI) score after 16 weeks of treatment.

While dupilumab is generally well-tolerated, conjunctivitis was the most common side effect, occurring in 26.1% of patients, highlighting the need for ongoing monitoring of adverse events in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis. Halling, AS., Loft, N., Silverberg, JI., et al.[2021]

Dupilumab effectively improves signs, symptoms, and quality of life in adolescents with moderate to severe atopic dermatitis (AD) by targeting key inflammatory pathways, specifically blocking IL-4 and IL-13 receptors.

The safety profile of dupilumab in adolescents is similar to that in adults, with common side effects including injection-site reactions and conjunctivitis, while skin infections were less frequent compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of adolescents with atopic dermatitis. Senner, S., Seegräber, M., Frey, S., et al.[2021]

In a real-life study of 241 adults with atopic dermatitis treated with dupilumab, significant improvements were observed in skin severity scores after 3 months, with 48.8% of patients achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI).

However, the study also found a higher incidence of conjunctivitis (38.2% of patients) and increased eosinophilia (57% during follow-up) compared to baseline, indicating potential safety concerns associated with dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. Faiz, S., Giovannelli, J., Podevin, C., et al.[2019]

In a study of 95 patients with moderate-to-severe atopic dermatitis treated with dupilumab for at least 12 weeks, significant improvements were observed in both physician-reported and patient-reported outcome measures, aligning with previous clinical trial results.

While dupilumab was generally well-tolerated, common side effects included eye symptoms in 62% of patients and orofacial herpes simplex virus reactivation in 8%, but no major safety concerns were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. de Wijs, LEM., Bosma, AL., Erler, NS., 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]

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 effectively treats moderate-to-severe atopic dermatitis by blocking IL-4/IL-13 signaling, leading to significant improvements in clinical measures like SCORAD and EASI, as well as patient-reported outcomes such as itch severity.

The safety profile of dupilumab is better than traditional immunosuppressive drugs, with fewer skin infections reported compared to placebo, although it can cause injection-site reactions and conjunctivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for treatment of atopic dermatitis. Seegräber, M., Srour, J., Walter, A., et al.[2019]

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 is the first biological medication approved for treating moderate-to-severe atopic dermatitis, demonstrating significant effectiveness and a favorable safety profile.

Despite its overall safety, there have been rare cases of local Staphylococcus aureus infections reported in patients undergoing dupilumab treatment for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Dupilumab leads to an increased chance of head and neck Staphylococcus aureus infection in atopic dermatitis patients. Chen, M., Gao, K., Ali, K., et al.[2023]

In a study of 1775 patients with atopic dermatitis using dupilumab, there was a 6-month risk of conjunctivitis of 6.5%, which is significantly higher compared to other treatments like methotrexate (3.3%) and mycophenolate (1.2%).

Dupilumab was associated with a low risk of serious infections (0.6%), similar to methotrexate (1.0%), indicating that while it is effective, the increased risk of conjunctivitis should be monitored and managed in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab and the risk of conjunctivitis and serious infection in patients with atopic dermatitis: A propensity score-matched cohort study. Schneeweiss, MC., Kim, SC., Wyss, R., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223 ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy000000185DEAQ/nct02260986

Study to Assess the Efficacy and Long-term Safety of ... Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5655850/

Exploratory Population PK Analysis of Dupilumab, a Fully ... An exploratory population pharmacokinetic model for functional dupilumab was developed. Data from healthy volunteers and patients with atopic dermatitis (AD)

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1314768

Dupilumab Treatment in Adults with Moderate-to-Severe ... Blocking IL-4Rα signaling with REGN668/SAR231893 rapidly suppresses major pathogenic pathways in severe atopic dermatitis. J Invest Dermatol ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01639040

NCT01639040 | Study to Assess the Safety of Dupilumab ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...

6. 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02407756

NCT02407756 | A Study to Determine the Safety and ... A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/​SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema).

8. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019m2EAA/nct01639040

Study to Assess the Safety of Dupilumab (REGN668 ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...

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

Patient outcomes and safety of combination biologic ... Combination biologic therapy with dupilumab is well-tolerated in select patients, suggesting promising efficacy in addressing comorbid conditions, refractory ...