Dupilumab for Prurigo Nodularis
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
Must not be taking: Biologics, Immunosuppressants
Disqualifiers: Atopic dermatitis, Infections, Immunodeficiency, others
No Placebo Group
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 Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.
The study consists of 3 periods:
* Screening period: 2 to 4 weeks.
* Treatment period: 24 weeks.
* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).
The total number of planned study visits for each participant will be 6.
Will I have to stop taking my current medications?
The trial requires that you stop taking biologic therapy or systemic immunosuppressants at least 4 weeks before the screening visit. If you are on these medications, you will need to stop them before joining the study.
What data supports the effectiveness of the drug Dupilumab for treating prurigo nodularis?
Dupilumab has been shown to reduce itching and the number of skin lesions in prurigo nodularis, as demonstrated in two randomized controlled trials. Additionally, case studies and literature reviews indicate that patients with severe prurigo nodularis experienced significant improvement with Dupilumab, and it is generally well-tolerated.
12345Is dupilumab safe for treating prurigo nodularis?
Dupilumab has been generally well-tolerated in studies for prurigo nodularis, with some patients experiencing mild side effects like dry eyes. It has shown good safety in clinical trials for other conditions like atopic dermatitis.
12356How does the drug Dupilumab differ from other treatments for prurigo nodularis?
Dupilumab is unique because it is the first approved therapy specifically for prurigo nodularis, working by blocking certain proteins (IL-4 and IL-13) that cause inflammation, which helps reduce itching and skin lesions. It is administered as an injection under the skin and has shown good safety and effectiveness in clinical trials, unlike other treatments that often have severe side effects.
13567Eligibility Criteria
This clinical trial is for children and teenagers from 6 months to under 18 years old with Prurigo Nodularis, a skin condition causing itchy lumps. They must have been diagnosed at least 3 months prior, have an itch intensity score of ≥7, and lesions on multiple body areas. Participants need to be able to use an e-Diary daily.Inclusion Criteria
I am between 6 months and 18 years old.
Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study
+2 more
Exclusion Criteria
I am expecting to undergo a major surgery during the trial.
I have not needed antibiotics, antivirals, or antifungals for an infection in the last 2 weeks.
Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 to 4 weeks
Treatment
Participants receive dupilumab administered subcutaneously based on weight and age for 24 weeks
24 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
16 weeks
Participant Groups
The study tests Dupilumab's effects on young patients with Prurigo Nodularis over approximately one year. It includes a screening period, a treatment phase lasting six months where the drug is given, followed by four months of observation without treatment.
1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Administered subcutaneously (SC) based on weight and age
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:
MediSearch Clinical Trials (Dermatology) Site Number : 8400004Saint Joseph, MO
Pediatric Center Of Excellence Site Number : 8400005Coral Gables, FL
Mission Dermatology Center Site Number : 8400011Rancho Santa Margarita, CA
Vital Prospects Clinical Research Institute, P.C. Site Number : 8400002Tulsa, OK
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Dupilumab for prurigo nodularis: Case series and review of the literature. [2021]Dupilumab is a recombinant complete human monoclonal antibody modulating the signaling of interleukin-4 and interleukin-13 pathways and has been approved for the treatment of moderate/severe atopic dermatitis. Here, we present three cases of prurigo nodularis treated off-label with dupilumab, and a review of the existing literature. All patients in this study had longstanding severe disease and had tried multiple treatment modalities. They were treated with dupilumab at an initial dose of 600 mg subcutaneously, followed by 300 mg every 2 weeks. Systematic literature searches were performed to identify literature describing the evaluation of the effect of treatment with dupilumab in prurigo nodularis. The physician's assessment of the patients revealed a good or excellent response to the treatment with dupilumab. Patients were evaluated after treatment for 4 and 7 months. Treatment was generally well-tolerated; one in three patients reported dry eyes. Four studies with a total of 11 patients (range: 1-4) were identified by the literature search. Complete response was noted in all 11 patients. Treatment with dupilumab appears to be safe and well-tolerated with clinical benefit in recalcitrant prurigo nodularis. Larger randomized and controlled trials using validated outcome measures are needed before dupilumab could be applied in clinical settings.
Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. [2022]Dupilumab has been shown effective for prurigo nodularis (PN). However, precise data about efficacy of dupilumab as off-label use in PN is missing. We aggregated current evidence to assess efficacy of dupilumab in PN and to identify possible response predictors.
New Dupilumab Indication for Rare Skin Disease. [2023]Dupilumab (Dupixent) has been approved for the treatment of prurigo nodularis, a rare skin disease.Nurses should teach patients how to administer the drug subcutaneously using the prefilled syringe and how to discard the used syringe.
Dupilumab as promising treatment for prurigo nodularis: current evidences. [2022]Prurigo nodularis (PN) is a debilitating chronic disease characterized by intense itching and excoriated hyperkeratotic nodules distributed on the trunk and extremities, especially the extensor surfaces. The pathophysiology includes complex and not yet well-understood mechanisms involving inflammation and dysregulation of the nervous system. Currently, there are no approved therapies by the Food and Drug Administration (FDA) and the few treatment approaches for this condition are often ineffective and related to severe side effects. An emerging therapeutic option is dupilumab, a monoclonal antibody for adults and adolescents with moderate-to-severe atopic dermatitis, that inhibits interleukin-4 receptor alpha subunit (IL4-Rα) and the signaling pathways activated by interleukin (IL)-4 and IL-13. These cytokines seem to be involved in the development and perpetuation of PN and other type-2 inflammation diseases. Data on this topic are limited, but the emergent positive effects of this drug, reported in the literature and summarized in this review, suggest that it can be a safe and efficient therapy in PN.
Dupilumab for the Treatment of Prurigo Nodularis. [2023]Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by the presence of pruritic nodules. Dupilumab was approved by the US Food and Drug Administration in September 2022 and Health Canada in July 2023 for the treatment of PN. Dupilumab is a human monoclonal immunoglobulin G4 antibody that binds the interleukin (IL)-4 receptor alpha subunit, blocking intercellular signalling of IL-4 and IL-13. Inhibition of these cytokines downregulates the inflammatory response and improves disease severity and pruritus. Two randomized controlled trials have shown dupilumab to be effective in reducing pruritus and lesion count in patients with PN. The approval of dupilumab for PN represents the first approved therapy for PN and may indicate a paradigm shift in the way this condition is treated.
The effectiveness and safety of dupilumab in the management of refractory prurigo nodularis in 45 Chinese patients: A real-life observational study. [2023]Prurigo nodularis (PN) is a chronic, pruritic inflammatory skin disease characterized by severe skin itching and hyperkeratotic nodules. The existing treatment options for PN are limited by severe adverse effects. Dupilumab is an approved biological agent for treating atopic dermatitis and other type 2 inflammatory diseases in adults, showing good efficacy and safety in clinical trials. Recently, dupilumab has shown remarkable effects in patients with PN, but the data on Chinese patients are limited. This study aimed to evaluate the safety and efficacy of dupilumab to treat atopic and nonatopic PN in 45 Chinese patients. To our knowledge, this is the largest cohort to date to evaluate the safety and efficacy of dupilumab to treat atopic and nonatopic PN. To achieve this, 45 patients with PN from the department of dermatology of several Grade A hospitals in Shenzhen, China, were treated with off-label prescription dupilumab. We followed-up the patients on weeks 8 and 16, and the pruritus symptoms, changes in lesion color and area, and the quality of sleep and life were evaluated before and after treatment using the Pruritus Peak Numeric Rating Scale (PP-NRS, 0-10), the Dermatology Life Quality Index/Children's Dermatology Life Quality Index (DLQI/CDLQI, 0-30), and the Investigator's Global Assessment Scales for Stage and Activity (IGA/IGAa, 0-4) at weeks 2, 4, 8, 12, and 16. Total serum immunoglobin E and eosinophilic granulocyte levels were the main laboratory indices for patient evaluation. During treatment, the skin lesions and itching symptoms of these 45 patients were relieved remarkably within 2 weeks. All the PP-NRS, DLQI/CDLQI, and IGA/IGAa scores significantly improved from the baseline to 16-week dupilumab treatment (P
[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.