Trial Summary
What is the purpose of this trial?This trial tests a medication that reduces skin inflammation and itching in adults with severe, unexplained itching. It works by blocking proteins that cause these symptoms. The medication has shown promise in treating conditions like atopic dermatitis and asthma.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, you will be required to take a non-sedative antihistamine and a moisturizer during the trial.
What data supports the effectiveness of the drug Dupilumab for itching?
Dupilumab is effective in reducing itching because it blocks certain proteins (IL-4 and IL-13) involved in the itching process, and it is already approved for treating atopic dermatitis, a condition where itching is a major symptom.
12345What safety data exists for Dupilumab (Dupixent) in humans?
Dupilumab, used for conditions like atopic dermatitis, has been associated with some side effects, including injection site reactions, conjunctivitis (eye inflammation), headaches, and nasopharyngitis (cold-like symptoms). Some patients have experienced facial redness and neck dermatitis, and there is a risk of ocular (eye-related) adverse reactions, which need prompt management.
13678What makes the drug Dupilumab unique for treating itching?
Dupilumab is unique because it is a monoclonal antibody that targets the interleukin-4 receptor, blocking signals from IL-4 and IL-13, which are involved in allergic responses. This mechanism is different from typical treatments that may not specifically target these pathways.
1391011Eligibility Criteria
Adults aged 18-90 with severe, chronic itching of unknown origin that affects at least two body areas (legs, arms, or trunk) and have not found relief from previous treatments. Participants must score 'severe' on itch severity scales and be in good health otherwise. Those with certain infections, immune deficiencies, severe kidney failure, hypersensitivity to antihistamines or a history of cancer within the last five years are excluded.Inclusion Criteria
I am between 18 and 90 years old.
I have severe itching with a score of 7 or more and consider my itching to be severe.
My severe itching has not improved with past treatments.
Exclusion Criteria
I have previously participated in a dupilumab study or used dupilumab.
I am HIV positive.
I am on dialysis for severe kidney failure.
Participant Groups
The trial is testing Dupilumab's effectiveness for treating chronic itching without a known cause over a period of either 12 or 24 weeks. It involves two parallel studies where participants also use non-sedative antihistamines and moisturizers. They're randomly assigned to receive either Dupilumab or a placebo in addition to their current regimen.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment3 Interventions
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer
Group II: PlaceboPlacebo Group3 Interventions
Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer
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:
Dawes Fretzin Clinical Research Group, LLC-Site Number:8400007Indianapolis, IN
Investigational Site Number :1240003Markham, Canada
Investigational Site Number :1240002London, Canada
University of Miami-Site Number:8400011Miami, FL
More Trial Locations
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Who is running the clinical trial?
SanofiLead Sponsor
References
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 for cancer-associated refractory pruritus. [2023]Pruritus can be an intolerable symptom in patients with cancer. Type 2 inflammation, and specifically, the cytokines IL-4, IL-13, and IL-31, play major roles in the itching process. Dupilumab is an antibody against IL-4Rα, which is a common IL-4 and IL-13 receptor subunit. Blocking IL-4 and IL-13 activity reduces the synthesis of IL-31, the "itch cytokine," and receptors for these 3 cytokines are expressed on itch nerves. Dupilumab is approved for treating moderate-to-severe atopic dermatitis, of which itching is a significant symptom.
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.
[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. [2023]Dupilumab is a humanized IgG4 monoclonal antibody that targets the IL-4 receptor inhibiting the signaling of interleukin-4 and interleukin-13, two major cytokines in type 2 inflammatory diseases such as atopic dermatitis, asthma and nasosinusal polyposis. Since its approval for atopic dermatitis in 2017, the molecule has occasionally been used off-label in several dermatological conditions where standard treatments are often disappointing.Furthermore, what emerges from the data currently in the literature is a favourable safety profile with few, reversible side effects.
Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]Dupilumab (Dupixent) for atopic dermatitis.
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.
Dupilumab facial redness: histologic characterization on a series of four cases. [2022]Dupilumab-related head and neck dermatitis is an increasingly reported clinical manifestation occurring in 4-10% of patients on dupilumab that was apparently not reported in clinical trials. Out of 62 adult patients treated with dupilumab for atopic dermatitis in the authors' center, four cases (6%) of head and neck dermatitis were observed, for which a skin biopsy was obtained. Onset occurred between 8 and 24 weeks after initiation of dupilumab, and the reaction resolved after 8-12 weeks. Histopathology and immunohistochemical findings support the authors' hypothesis that facial redness may be a toxic effect induced by dupilumab, although its pathogenesis still requires further investigation.
Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]Dupilumab is a monoclonal antibody against the IL-4/IL-13 receptor-subunit approved for the treatment of moderate-severe atopic dermatitis (AD). Some attempts to increase dose interval have been described in both trial and real-world settings.
Facial erythema after the treatment of dupilumab in SLE patient. [2022]Dupilumab is a receptor antagonist binding to the alpha subunit of the interleukin-4 receptor. Through binding to it, dupilumab inhibits signaling of both IL-4 and IL-13, the representative Th2 biomarkers. Recently, in addition to the treatment effects for atopic dermatitis (AD), there is an emerging adverse event as facial erythema.
The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study. [2022]Dupilumab is an antibody against interleukin-4 receptor α, used in the treatment of atopic dermatitis (AD).