Dupilumab for Eczema
(PELISTAD-EX2 Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Sanofi
Must be taking: Dupixent
Must not be taking: Systemic corticosteroids, JAK inhibitors
Disqualifiers: Severe illness, Skin conditions, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and \<15 years at study entry) with moderate-to-severe AD. All eligible participants with AD will be treated with Dupixent® for 104 weeks according to locally approved Dupixent® product label (in country/region where the study is conducted). After the 104-week treatment phase and the last assessment at the End of Treatment (EoT), participants will be followed-up for 4 weeks and an End-of-Study (EoS) visit by telephone at 4 weeks after the EoT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period).
The study population will include approximately 48 pediatric participants with AD for long-term treatment with dupilumab:
* Treatment cohort 1 - newly recruited participants with AD (aged ≥6 to \<12 years at study entry)
* Treatment cohort 2 - any former PELISTAD participants (from the previous 16-week treatment study \[PELISTAD/LPS16764\] who consent to participate in this long-term study; aged ≥6 to \<15 years at entry to this study)
Will I have to stop taking my current medications?
Yes, you will need to stop certain medications before joining the trial. Systemic treatments for eczema and some topical treatments must be stopped 4 weeks and 1 week before the trial starts, respectively. However, face and neck can be treated with topical steroids during the washout period if approved by the Investigator.
What data supports the effectiveness of the drug Dupilumab for eczema?
Dupilumab has been shown to improve symptoms of moderate-to-severe eczema, such as skin inflammation, itching, and sleep disturbances, in adults who did not respond well to other treatments. It is generally well tolerated and provides long-term benefits when used alone or with topical corticosteroids.
12345Is Dupilumab safe for treating eczema?
Dupilumab is generally considered safe for treating eczema, with common side effects including injection site reactions, conjunctivitis (eye inflammation), headache, and nasopharyngitis (cold-like symptoms). Some rare side effects have been reported, such as increased sweating and certain eye conditions, but overall, its safety profile is comparable to a placebo.
56789How is the drug Dupilumab unique for treating eczema?
Dupilumab is unique because it is the first FDA-approved biological therapy for moderate-to-severe eczema that works by blocking the IL-4 receptor, which helps reduce inflammation. Unlike traditional topical treatments, it is administered as an injection and is specifically designed for patients whose eczema is not well-controlled with topical therapies.
4591011Eligibility Criteria
This trial is for children aged 6 to under 15 with moderate-to-severe atopic dermatitis (eczema). They must meet specific criteria including having had the condition for at least a year and, if new participants, have certain severity in skin lesions. Participants need to be able to avoid topical medications on target areas during the study unless absolutely needed.Inclusion Criteria
My disease type matches the study's requirements.
The participant should have an unblemished skin area situated 4 cm away from the edge of the affected region
My eczema is moderate to severe, depending on where I live.
+14 more
Exclusion Criteria
I haven't taken specific immune system medications or undergone phototherapy in the last 4 weeks.
Hypersensitivity to the active substance or to any of the excipients of dupilumab.
I haven't taken any experimental drugs recently, except for dupilumab.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Treatment
Participants receive open-label dupilumab treatment for 104 weeks
104 weeks
Regular visits according to local prescribing label
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (telephone)
Participant Groups
The trial tests Dupilumab's long-term effects on skin barrier function in pediatric patients with eczema over a period of two years. It measures how well the skin retains moisture before and after a procedure that stresses the skin. All participants will receive Dupilumab according to local guidelines.
1Treatment groups
Experimental Treatment
Group I: Pediatric AD participantsExperimental Treatment1 Intervention
Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Louis University SLUCare Academic Pavilion Site Number : 8400006Saint Louis, MO
New York University Langone Health Site Number : 8400004New York, NY
National Jewish Center Site Number : 8400001Denver, CO
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. [2019]Dupilumab (Dupixent®), a subcutaneously administered, fully human IgG4 monoclonal antibody directed against the IL (interleukin)-4 receptor α subunit, blocks the signalling of IL-4 and IL-13, two T helper cell type 2 cytokines implicated in the immunopathology of atopic dermatitis (AD). It is the first biologic therapy to have been approved for the treatment of adult patients with moderate-to-severe AD in the EU and USA. In phase III trials in adults with moderate-to-severe AD who were inadequately controlled with topical medications and/or systemic treatments, such as ciclosporin, or for whom these therapies were not advisable, 16 weeks' treatment with dupilumab as monotherapy or in combination with topical corticosteroids (TCS) improved multiple measures of disease severity, pruritus, sleep disturbance, anxiety and depression, and quality of life compared with placebo. Moreover, the benefits of combination therapy at week 16 were maintained during long-term treatment for up to 1 year. Dupilumab, alone or added to TCS, was generally well tolerated, with low rates of serious adverse events and treatment discontinuations due to adverse events. Common adverse reactions included conjunctivitis, injection-site reactions and oral herpes. Thus, dupilumab represents a valuable new treatment option for adults with moderate-to-severe AD deemed appropriate for systemic therapy, a patient population for whom historically there has been a lack of safe and effective long-term treatments.
Dupixent, a New Entrant In the Asthma Lists. [2019]Sanofi and Regeneron's Dupixent (dupilumab)-which is already approved for atopic dermatitis-has an FDA action date of October 20 for its asthma indication. It will join Nucala, (mepolizumab), Cinqair (reslizumab), and Fasenra (benralizumab) as a monoclonal antibody approved as a treatment for the type 2 inflammation phenotype in severe asthma.
Dupilumab for the treatment of adolescents with atopic dermatitis. [2021]Dupilumab is a treatment option newly licensed for adolescents with moderate to severe atopic dermatitis (AD). It reduces type 2 inflammation by blocking the shared receptor subunit for IL-4/-13. Dupilumab affects three disease mechanisms in atopic dermatitis: the skin barrier, the Th2-cell differentiation and the class switch to IgE. This report is based on a systematic literature search of the PubMed Database.
Dupilumab: First Global Approval. [2022]Dupilumab (Dupixent®) is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α (IL-4Rα) subunit. Dupilumab inhibits the signalling of the type 2 cytokines IL-4 and IL-13 and was co-developed by Regeneron Pharmaceuticals and Sanofi as a potential therapeutic agent for the treatment of atopic or allergic diseases. In March 2017 dupilumab received its first global approval, in the USA, for use in the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab is in preregistration for this indication in the EU. In addition, dupilumab is currently under phase III development across the world for the treatment of asthma and nasal polyposis as well as for atopic dermatitis in paediatric patients. The agent has also entered phase II development in the USA for the treatment of eosinophilic oesophagitis. This article summarizes the milestones in the development of dupilumab leading to this first approval for the treatment of moderate-to-severe atopic dermatitis in adults.
Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. [2022]Atopic dermatitis (AD, eczema) is familial chronic inflammatory skin disease of complex etiology and increasing prevalence. Dupilumab is an IL-4 receptor subunit alpha (IL-4Rα) antagonist that is the first Food and Drug Administration-approved biological therapy for moderate-to-severe adult AD inadequately controlled with topical therapies. Adverse effects reported in the literature include injection site reactions, conjunctivitis, headache, and nasopharyngitis.
Safety update: dupilumab and ocular adverse reactions. [2022]Overview of: Medicines and Healthcare products Regulatory Agency. Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management. Drug Safety Update 2022;16(4): 1.
Dupilumab side effect in a patient with atopic dermatitis: a case report study. [2020]Atopic dermatitis (eczema) is a common chronic disease that is described as severe itching associated with recurrent eczematous lesions. In 2017 the US Food and Drug Administration approved dupilumab for treatment of adults with moderate to severe atopic dermatitis not well controlled with topical therapies or when other therapies are inadvisable. Dupilumab is a monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling by specifically binding to the IL-4R-alpha subunit shared by the IL-4 and IL-13 receptor complexes. There are many adverse effects reported after dupilumab therapy; commonly reported adverse effects include local injection site reactions, conjunctivitis, headache, and nasopharyngitis. Some adverse effects are rare, eg, alopecia areata and cicatricial extropion. We report a new case of a 28-year-old female who experienced face and neck rash after dupilumab injection.
Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. [2022]Atopic dermatitis (AD) is a type 2 chronic skin disorder associated with systemic and psychosocial comorbidities decreasing the quality of life for many patients. Dupilumab, a human monoclonal antibody that blocks interleukins IL-4 and IL-13, is a recently added systematic treatment option with an emerging evidence base. Here, we assessed the safety and efficacy of dupilumab in patients with AD. We conducted a systematic review and meta-analysis of placebo-controlled randomized clinical trials evaluating the safety and efficacy of dupilumab on AD-related outcomes including clinical symptoms, quality of life and adverse events (AE). Subgroup analysis was further performed in adults and children/adolescents. Fourteen trials were included: twelve in adults (n = 3,817) and two in children/adolescents (n = 618). Dupilumab decreased the Eczema Area Severity Index (EASI) score [standardized mean difference (SMD) = -0.98; 95% confidence interval (95% CI) = (-1.09, -0.88)], the percent change difference in Scoring Atopic Dermatitis (SCORAD) [mean difference (MD) = -31.56, 95% CI = (-33.75, -29.36)], and in pruritus Numeric Rating Scale (pNRS) [MD = -29.24, 95% CI = (-32.11, -26.37)]. It also achieved a reduction of at least ≥75% in the EASI score [Risk Ratio (RR) = 2.89, 95% CI = (2.47, 3.38)], the Investigator's Global Assessment (IGA) score ≤1 [RR = 3.47, 95% CI = (2.96, 4.06)] and eight additional endpoints with no signs of increased AE compared to placebo. In subgroup analysis, the results were concordant for both groups. Dupilumab improved clinical symptoms and quality of life in adults and children/adolescents with a safety profile comparable to placebo.
Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]Dupilumab is the first human monoclonal antibody approved for the treatment of atopic dermatitis (AD). Clinical trials have reported an increase of ocular side effects in patients who receive dupilumab, with a prevalence of 5-37%.
Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]Dupilumab (Dupixent) for atopic dermatitis.
Dupilumab in pediatric dermatology. [2022]Dupilumab is a monoclonal antibody that targets the interleukin (IL)-4 receptor alpha subunit of the IL-4 and IL-13 receptor. This novel agent has received a license for the treatment of moderate-to-severe atopic dermatitis in patients aged ≥12 years. However, data on the dupilumab use in the pediatric population are still extremely limited. This report aims to summarize the existing data on the on- and off-label use of dupilumab for dermatologic conditions in children and adolescents.