Dupilumab for Chronic Itch
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
Disqualifiers: Prurigo nodularis, Atopic dermatitis, Psoriasis, others
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC. Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
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, but it mentions a 'washout period' for those who have had systemic treatment for LSC in the past 6 months. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Dupilumab for treating chronic itch?
Dupilumab has shown significant effectiveness in reducing chronic itch, particularly in conditions like atopic dermatitis, where it greatly reduces itch severity. In a study, 89% of patients experienced a significant reduction in itch severity, and 83% noticed improvement within four weeks of starting treatment.12345
Is dupilumab generally safe for humans?
Dupilumab is generally considered safe, but common side effects include injection site reactions, conjunctivitis (eye inflammation), and nasopharyngitis (cold-like symptoms). Some patients may experience head and neck dermatitis, facial redness, or rare conditions like alopecia areata (hair loss) and cicatricial ectropion (eyelid turning outwards). Most side effects are mild and do not require stopping the treatment.16789
How is the drug Dupilumab unique for treating chronic itch?
Eligibility Criteria
This trial is for adults with Lichen Simplex Chronicus (LSC) who have at least two lesions, one severe lesion, and a history of the condition for six months or more. Participants must have tried and failed a course of topical treatments within the last six months or be unable to use them. They should not be on systemic treatments other than antihistamines.Inclusion Criteria
I am at least 18 years old or the legal age of consent where the study is conducted.
I have at least one lesion in the genital or anal area.
I have at least two tumors, with one being 3 cm or larger.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive dupilumab or placebo subcutaneous injections to measure improvement in pruritus
24 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Treatment Details
Interventions
- Dupilumab (Monoclonal Antibodies)
Trial OverviewThe study compares Dupilumab injections against placebo in treating pruritus (itchiness) associated with LSC. It's a Phase 3 trial where participants will receive treatment for up to 24 weeks and then be followed up for another 12 weeks over six visits.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Dupilumab subcutaneous injection as per protocol
Group II: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injection as per protocol
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:
Investigational Site Number : 1240001London, Canada
Investigational Site Number : 1240002Saskatoon, Canada
Dermatology Research Associates - Los Angeles- Site Number : 8400004Los Angeles, CA
Equity Medical- Site Number : 8400017New York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead 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.
Efficacy of dupilumab in chronic prurigo and chronic idiopathic pruritus: a systematic review of current evidence and analysis of response predictors. [2022]Dupilumab has demonstrated a great reduction in chronic pruritus that is the hallmark of atopic dermatitis (AD). Underscoring relevant pathogenesis similarities emerging from AD, chronic idiopathic pruritus (CIP) and chronic prurigo (CP), several authors suggested the beneficial role of dupilumab in these conditions. The evidence on this subject is limited with no precise data available. In this study, we carried out a systematic literature review in order to evaluate the efficacy of dupilumab on both pruritus and skin manifestations in the two largest retrospective cohorts of patients with CP and CIP and tried to identify potential response predictors. Electronic searches were conducted on 4 databases. Our primary outcome was the improvement in pruritus measured by a reduction in the patient's reported numerical rating scale of itch (NRSI) by >4. Secondary outcomes included the proportion of patients with a complete response at the end of treatment, reduction in the number of lesions by the Investigator Global Assessment (IGA), improvement in numerical rating scale of sleep (NRSS), improvement in quality of life measured by the Dermatology Life Quality Index (DLQI), time until patient perceived any improvement (Time-First) and time until the patient-reported absence of pruritus (Time-Final). Descriptive statistics were calculated for each demographic and clinical variable. Univariate logistic regression analyses were conducted to explore the association between response to dupilumab and potential predictive factors. We included 25 articles in the analysis, counting a total of 153 patients. Based on CP patients' cohort (n = 132), the mean NRSI at baseline was 8.79 ± 0.86 and the NRSI final was 2.32 ± 1.27. The mean time to first improvement was 5.18 ± 3.13 weeks, while the time to complete improvement of pruritus (Time-final) was 13.6 ± 12.0 weeks. 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%) had a complete remission of pruritus and 110 patients out of 123 (89%) had a reduction of NRSI >4. The reduction in NRSI was significantly greater in patients improving before 4 weeks of treatment (6.57 ± 1.71) compared with patients improving in more than 4 weeks (5.49 ± 1.39, P 4. No serious treatment-emergent adverse events were reported. The most common adverse event was mild conjunctivitis (13 cases). We highlight the importance of one early sign of improvement as a predictor of the future response to dupilumab: the improvement before 4 weeks of treatment that leads significantly to a greater final reduction in NRSI. Furthermore, patients with the presence or history of atopy appear to be less responsive to dupilumab than nonatopic patients and develop more side effects, in particular conjunctivitis.
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 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).
[Psoriasis in dupilumab-treated atopic dermatitis]. [2020]Dupilumab is a monoclonal antibody that binds to the common alpha chain of the IL‑4 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.
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.
Long-term real-world experience of the side effects of dupilumab in 128 patients with atopic dermatitis and related conditions aged 6 years and above: Retrospective chart analysis from a single tertiary care center. [2022]Dupilumab is a monoclonal antibody against interleukins 4 and 13 currently FDA approved for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents and severe AD in children aged 6-11 years. It is reported to be safe with the most common side effects described from clinical trials being conjunctivitis, nasopharyngitis and injection site reactions. Outside the clinical trial setting, there is insufficient data on the side effects of dupilumab in adults with AD, and much less among children and adolescents. The aim of this study was to analyze the spectrum of side effects in all patients receiving dupilumab for the treatment of AD and related conditions in a real-world setting at a single tertiary referral center, and correlate any risk factors for the development of these side effects. A retrospective review of electronic medical records was conducted for all patients who had received dupilumab for a minimum of 2 months for the treatment of AD and related conditions in the department of dermatology at Rashid hospital, Dubai from February 2018 to November 2021. We analyzed the medical records of 128 patients who received dupilumab according to standard age-related dosing. This included 78 adults (age range 18-81 years) and 50 children and adolescents (aged 6-17 years). There were 73 males and 55 females. The mean duration of dupilumab treatment was 14.9 months. The most common side effects encountered during dupilumab therapy were head and neck dermatitis in 25 (19.5%), conjunctivitis in 20 (15.6%), erythema, pruritus and peeling of skin in 14 (10.9%) and dryness of eyes in 10 (7.8%) patients, respectively. Overall, dupilumab was well-tolerated in our patient population. Most of the side effects were mild and did not require discontinuation of dupilumab. These findings would enable dermatologists understand the side effects of dupilumab better, resulting in improved treatment plan decisions in clinical practice.
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.
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%.