Upadacitinib for Prurigo Nodularis
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Psoriasis Treatment Center of Central New Jersey
Must not be taking: Antibiotics, Antivirals, Antiprotozoals, Antifungals
Disqualifiers: Active infections, Active malignancy, Severe renal, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Upadacitinib for treating prurigo nodularis?
Upadacitinib has shown effectiveness in rapidly reducing itch and improving skin condition in patients with moderate-to-severe atopic dermatitis, a condition characterized by intense itching, which suggests it may also help with prurigo nodularis, another itchy skin condition.
12345How does the drug Upadacitinib differ from other treatments for prurigo nodularis?
Upadacitinib is unique because it is a Janus kinase (JAK) inhibitor, which works by blocking specific pathways involved in inflammation, potentially offering a new approach for treating prurigo nodularis compared to existing treatments that focus on different mechanisms.
678910Eligibility Criteria
Adults aged 18-64 with moderate-to-severe prurigo nodularis, having at least 10 lesions and not responding to certain creams. Women must not be pregnant or breastfeeding and use birth control. Excludes those with severe kidney issues, recent cancers (except some skin cancers), active infections including TB, other skin conditions, or uncontrolled illnesses.Inclusion Criteria
I am not pregnant, not breastfeeding, and using birth control if able to have children.
I have moderate-to-severe itchy bumps on my legs, arms, or trunk.
I've tried strong skin creams for 2 weeks without success or can't use them for health reasons.
+5 more
Exclusion Criteria
I have severe kidney problems or am on dialysis.
I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that's been fully treated.
I do not have active TB, or if I had TB, it was fully treated.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 15mg upadacitinib for 24 weeks, with an option to increase to 30mg at week 8 if necessary
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing Upadacitinib for patients with prurigo nodularis over a period of 24 weeks. It's an open-label study at a single center involving 25 subjects who have had inadequate responses to topical treatments.
1Treatment groups
Experimental Treatment
Group I: UpadacitinibExperimental Treatment1 Intervention
Open-label use of 15mg upadacitinib. Subjects have the option to increase to 30mg at week 8 if the investigator deems it necessary.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Eczema Treatment Center of New JerseyEast Windsor, NJ
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Who Is Running the Clinical Trial?
Psoriasis Treatment Center of Central New JerseyLead Sponsor
AbbVieIndustry Sponsor
References
Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. [2022]Acne is the most frequent adverse event associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis.
Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. [2023]Upadacitinib is a selective reversible Janus kinase (JAK) inhibitor with established efficacy in moderate-to-severe atopic dermatitis (AD).
Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study. [2023]Upadacitinib, an oral, selective Janus kinase inhibitor, is approved in Japan for the treatment of moderate-to-severe atopic dermatitis (AD), a chronic inflammatory skin disease characterized by eczematous morphology and intense itch.
Upadacitinib effectiveness in moderate-to-severe atopic dermatitis: A real-life multicentre and retrospective study. [2023]This was an observational and retrospective multicentre study conducted on adolescents and adults diagnosed with moderate-to-severe atopic dermatitis (AD) and treated with upadacitinib. Disease severity was measured by Eczema Area and Severity Index (EASI), validated investigator global assessment for AD and pruritus Numerical Rating Scale (NRS) at baseline and Weeks 4, 16, 24 and 52 (when available). Twenty-one patients were included. All patients had previously received topical and systemic corticosteroids. Rapid response to upadacitinib was observed: Mean (SD) EASI score was 19.8 (6.5) at baseline, and 3.1 (4.2), 0.9 (1.4), 0.6 (0.6) and 0.6 (0.6) at the Weeks 4, 16, 24 and 52, respectively. Itch was controlled at Week 4 in all patients (mean [SD] NRS score 7.6 [1.9] baseline, 1.5 [1.3] W4). Severe infections or major adverse cardiovascular events were not reported. We highlight effectiveness and rapid response of upadacitinib in achieving itch control even in long-standing recalcitrant cases.
Early itch relief with upadacitinib predicts later skin clearance in Atopic dermatitis. [2023]Though Janus kinase inhibitors such as upadacitinib rapidly relieve itch in atopic dermatitis (AD) patients, how early itch relief impacts later skin clearance is not examined.
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.
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.
A systematic review of evidence-based treatments for prurigo nodularis. [2019]Prurigo nodularis is a chronic dermatologic condition involving the development of multiple cutaneous nodules in the setting of intractable pruritus. Given emerging treatment options for this difficult-to-treat condition, a current review of therapeutics is needed. A systematic review was performed for clinical studies investigating prurigo nodularis treatment published from 1990 to present including ≥5 subjects. A total of 35 articles were assigned a level of evidence according to the Oxford Center for Evidence-based Medicine. All 5 studies investigating topical agents, including corticosteroids, calcineurin inhibitors, calcipotriol, and capsaicin, conveyed some beneficial effect with level of evidence 2b or higher. Six of 8 reports investigating photo- and photochemotherapy achieved levels of evidence 2b or greater and showed good partial response rates. Thalidomide was studied by 6 reports providing evidence of good symptom response, only 2 of which were rated level 2b or greater. Cyclosporine and methotrexate have demonstrated benefit in 4 combined studies, albeit with level 4 evidence. Pregabalin, amitriptyline, paroxetine, fluvoxamine, and neurokinin-1 receptor antagonists have demonstrated promising evidence in 5 level 2b studies. Higher-powered studies and additional randomized controlled trials are needed for the evaluation of safe and efficacious systemic treatment options for prurigo nodularis.
Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. [2023]Prurigo nodularis is a chronic, debilitating, and severely pruritic neuroimmunologic skin disease. Nemolizumab, an interleukin-31 receptor alpha antagonist, down-regulates key pathways in the pathogenesis of prurigo nodularis.