Trial Summary
What is the purpose of this trial?To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
What data supports the idea that Dupilumab for Severe Chronic Itching is an effective drug?The available research shows that Dupilumab is effective in treating severe chronic itching, particularly in conditions like atopic dermatitis. It works by blocking certain proteins that cause inflammation and itching. Although the research primarily focuses on atopic dermatitis, where itching is a major symptom, it suggests that Dupilumab can significantly reduce itching by targeting the proteins involved in the itch process. This makes it a promising option for those suffering from severe chronic itching.145610
Do I have to stop taking my current medications?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using selective opioid antagonists.
What safety data exists for Dupilumab?Dupilumab, approved for moderate to severe atopic dermatitis, has been associated with several adverse effects. Commonly reported side effects include injection site reactions, conjunctivitis, headache, and nasopharyngitis. Rare effects include alopecia areata and cicatricial ectropion. Facial redness and head and neck dermatitis have been observed in 4-10% of patients, although not initially reported in clinical trials. Ocular adverse reactions are noted, requiring prompt management. Real-world data suggest additional adverse events like blood eosinophilia, rosacea-like skin lesions, and weight gain, but their direct link to dupilumab is unclear. Overall, dupilumab is considered well-tolerated, but long-term safety data and registries are needed to monitor future adverse events.13789
Eligibility Criteria
This trial is for adults over 18 with moderate to severe itching due to liver disease lasting more than 6 weeks. Participants must be able to follow the trial procedures and not have a history of certain conditions like liver malignancy, past liver transplants, or specific types of pruritus. Pregnant individuals and those with severe asthma or allergies to dupilumab are excluded.Inclusion Criteria
I am 18 or older with long-term severe itching due to liver disease.
Exclusion Criteria
I have itching due to skin inflammation or a psychological condition.
I experience chronic itching due to liver-related cancer.
I have received a liver transplant.
I am under 18 years old.
I have a known worm infection.
I do not have severe asthma that needs high-dose steroids.
I am currently taking selective opioid antagonists.
Treatment Details
The trial is testing Dupilumab, an injectable medication, for its effectiveness in treating chronic itching associated with liver disease. The goal is to see if this drug can provide relief from persistent and intense itching.
1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
Dupilumab is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Dupixent for:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
๐ช๐บ 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:
Mayo Clinic FloridaJacksonville, FL
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
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 (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]Dupilumab (Dupixent) for atopic dermatitis.
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.
Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial. [2021]The dupilumab regimen of 300 mg every 2 weeks is approved for uncontrolled, moderate to severe atopic dermatitis (AD).
[Psoriasis in dupilumab-treated atopic dermatitis]. [2020]Dupilumab is a monoclonal antibody that binds to the common alpha chain of the ILโ4 and IL-13 receptor and blocks the Th2 signaling pathway, which plays a key role in the development of atopic dermatitis. We report on the case of a 40-year-old man, who developed histologically confirmed psoriasis after 6 weeks of dupilumab therapy. The arbitrary, abrupt stopping of the unusual, not guideline-based oral steroid therapy, together with the blockade of the Th2 signaling pathway by dupilumab were apparently the relevant trigger factors for the newly developed psoriasis in our patient.
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%.
Safety of dupilumab in patients with atopic dermatitis: expert opinion. [2021]Introduction: Dupilumab, the first biologic drug to be approved for the treatment of moderate to severe atopic dermatitis in adolescents and adults, has shown efficacy and safety in clinical trials. Data on long-term safety is limited but crucial for pharmacovigilance. Therefore, we performed this review to evaluate available real-world data on the long-term safety of dupilumab in atopic dermatitis.Areas covered: PubMed and Google Scholar databases were searched for randomized controlled clinical trials (RCTs), observational studies, case series, and case reports regarding the use of dupilumab for the treatment of atopic dermatitis. Adverse events were summarized and critically evaluated.Expert opinion: Atopic dermatitis patients receiving dupilumab reported ocular surface disease more often than patients receiving placebo. Real-world data show previously unreported adverse events (blood eosinophilia, rosacea-like skin lesions, weight gain), but their mechanistic association to dupilumab treatment still requires clarification. Cutaneous T-cell lymphomas occurring under the therapy with dupilumab might be unrelated to the drug use itself but long-term follow-up data of large patient cohorts is necessary to rule out such possibility. Real-world data show that dupilumab is well tolerated in atopic dermatitis; however, ocular adverse events are not rare. Registries are needed to monitor future adverse events.
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.
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 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-4Rฮฑ, 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 Treatment Efficacy and Impact on Clinical Scores, Serum Biomarkers, and Itch in Adult Patients with Atopic Dermatitis: A Retrospective Analysis. [2023]Dupilumab, a fully human monoclonal antibody that inhibits the signaling pathways of interleukin (IL)-4 and IL-13, has demonstrated remarkable efficacy in the treatment of atopic dermatitis (AD). Dupilumab has been reported to attenuate itch and reduce several serum markers, including blood lactate dehydrogenase (LDH), blood eosinophil count, and serum total immunoglobulin E (IgE).