Ruxolitinib Cream for Prurigo Nodularis
(TRuE-PN2 Trial)
Recruiting in Palo Alto (17 mi)
+100 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Incyte Corporation
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests the safety and tolerability of a cream for people with Prurigo Nodularis, a condition with itchy skin nodules. The cream works by blocking enzymes that cause inflammation and itching. It has been previously tested for its effects in conditions like atopic dermatitis.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you must stop taking your current medications. However, if you are using any prohibited medications, a washout period may be required.
What data supports the idea that Ruxolitinib Cream for Prurigo Nodularis is an effective treatment?
The available research shows that Ruxolitinib Cream is effective for treating atopic dermatitis, a condition similar to Prurigo Nodularis. In studies, patients using Ruxolitinib Cream had significant improvements in skin condition and itchiness compared to those using a placebo cream. For example, in one study, 93.4% of patients using Ruxolitinib Cream showed improvement, compared to 69% using the placebo. This suggests that Ruxolitinib Cream could also be effective for Prurigo Nodularis, as both conditions involve similar symptoms like itchiness and skin irritation.
12345What safety data is available for Ruxolitinib Cream?
Ruxolitinib Cream, also known as Opzelura, has been evaluated for safety in various studies. In phase III trials for atopic dermatitis, it was well tolerated with a safety profile similar to vehicle cream, showing infrequent application site adverse events like stinging or burning. A review of 24 studies involving 2618 patients across different dermatologic conditions found minimal bioavailability and low rates of mild-to-moderate treatment-related adverse events, indicating a favorable safety profile. Additionally, systemic administration of ruxolitinib has rare skin toxicity, and carcinogenicity studies in animals showed no increased incidence of neoplastic findings, suggesting it is not carcinogenic.
16789Is Ruxolitinib Cream a promising drug for treating Prurigo Nodularis?
Yes, Ruxolitinib Cream is a promising drug. It has shown significant improvements in skin conditions like atopic dermatitis, reducing itchiness and improving quality of life. It is well-tolerated and offers a safer alternative to other treatments.
12356Eligibility Criteria
This trial is for individuals with Prurigo Nodularis who've had it for at least 3 months, have a significant itch score (≥7), and more than six itchy lesions across two body areas. Participants must not be pregnant or planning to become so and should not have used certain medications recently.Inclusion Criteria
Do you have lesions on 2 or more different body areas (such as the right and left leg)?
Baseline PN-related WI-NRS score ≥ 7
I have been diagnosed with peripheral neuropathy for at least 3 months.
+3 more
Exclusion Criteria
Individuals not affiliated with the social security system
I am able to give my consent and am not under legal protection.
Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching
+13 more
Participant Groups
The study tests Ruxolitinib cream's effectiveness in reducing itching and improving skin condition compared to a placebo cream (Vehicle Cream). It aims to determine how safe and tolerable the medication is for people with Prurigo Nodularis.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ruxolitinib 1.5% CreamExperimental Treatment1 Intervention
Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
Group II: Vehicle CreamPlacebo Group1 Intervention
Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
Ruxolitinib Cream is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Opzelura for:
- Atopic Dermatitis
- Vitiligo
🇪🇺 Approved in European Union as Jakavi for:
- Myelofibrosis
- Polycythaemia vera
- Steroid-refractory acute graft-versus-host disease
- Chronic graft-versus-host disease
- Non-segmental vitiligo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical Science Institute Clinical Research Specialists IncSanta Monica, CA
Dermdox Center For DermatologySugarloaf, PA
Diex Recherche Quebec Inc.Quebec, Canada
Dermatology Research AssociatesLos Angeles, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Incyte CorporationLead Sponsor
References
Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]Ruxolitinib cream 1.5% (OPZELURA™) is a topical formulation of ruxolitinib, a potent, selective inhibitor of Janus kinase (JAK)1 and JAK2. The targeting of these kinases is associated with therapeutic benefits in patients with atopic dermatitis (AD). In two identically designed, multinational, phase III studies in patients aged ≥ 12 years with mild to moderate AD, ruxolitinib cream 1.5% improved measures of disease severity, pruritus and sleep disturbance relative to vehicle cream when applied twice daily for 8 weeks. Disease severity was controlled for the next 44 weeks when applied as needed to active lesions. Ruxolitinib cream 1.5% was well tolerated in this patient population; its safety profile was similar to that of vehicle cream over the short term, with the types of treatment-emergent adverse events typical of those seen in the vehicle-controlled period over the longer term. Moreover, application site treatment-emergent adverse events indicative of skin tolerability issues (e.g. stinging/burning sensation) were infrequent and no safety findings suggestive of systemic JAK inhibition were identified. Although further longer-term data would be of use, ruxolitinib cream 1.5% provides an alternative to established topical agents (e.g. corticosteroids and calcineurin inhibitors) for the treatment of mild to moderate AD in adults and adolescents.
A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. [2022]Ruxolitinib cream is a topical formulation of ruxolitinib, an inhibitor of Janus kinase 1 and Janus kinase 2.
Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. [2023]Ruxolitinib cream is a topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor.
Review of Ruxolitinib in the Treatment of Atopic Dermatitis. [2023]To review the pharmacokinetics, efficacy, and safety of a newly approved topical Janus kinase 1 (JAK) inhibitor, ruxolitinib (RUX), in patients with atopic dermatitis (AD).
Clinically relevant improvements in adults and adolescents with atopic dermatitis who did not achieve Investigator's Global Assessment treatment success following 8 weeks of ruxolitinib cream monotherapy. [2023]Ruxolitinib cream is a topical formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and JAK2. In two phase 3 studies in adults and adolescents (aged ≥12 years) with atopic dermatitis (AD; TRuE-AD1/TRuE-AD2), significantly more patients who applied ruxolitinib cream versus vehicle cream achieved Investigator's Global Assessment treatment success (IGA-TS; IGA score of 0/1 with ≥2-point improvement from baseline) at week 8 (primary endpoint). This post hoc analysis evaluated the efficacy, safety, and disease control of ruxolitinib cream in patients with AD who did not achieve IGA-TS at week 8. Patients in TRuE-AD1/TRuE-AD2 (N = 1249) were randomized 2:2:1 to apply twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks followed by a long-term safety period in which patients applied ruxolitinib cream as needed. In this pooled analysis, clinically meaningful response thresholds included ≥50% improvement in the Eczema Area and Severity Index, ≥2-point reduction in the Itch Numerical Rating Scale, ≥4-point improvement in the Dermatology Life Quality Index (DLQI) or ≥6-point improvement in Children's DLQI, and ≥1-point reduction in IGA from baseline. Among patients who did not achieve IGA-TS at week 8 (n = 584), significantly more patients who applied either strength ruxolitinib cream versus vehicle achieved each response threshold at week 8. A response in ≥1 clinically meaningful endpoint was achieved in significantly more patients who applied ruxolitinib cream (93.4%/90.9% for 0.75%/1.5% ruxolitinib cream, respectively) versus vehicle (69.0%, both P
Utilization of Topical Ruxolitinib in Dermatology: A Review. [2023]As systemic administration of Janus kinase-inhibitors is associated with safety concerns, local alternatives, such as topical ruxolitinib, have been developed. This review summarizes utilization of topical ruxolitinib in dermatology. A literature search was performed of studies reporting topical use of ruxolitinib in dermatologic conditions. Twenty-four articles were included, representing 2618 patients. Results show improvement with topical ruxolitinib formulations in atopic dermatitis, vitiligo, psoriasis, and lichen planus. Results are conflicting in alopecia areata. Minimal bioavailability and low rates of mild-to-moderate treatment-related adverse events support a favorable safety profile and higher tolerability of topical ruxolitinib compared to oral Janus kinase-inhibitors.
Erythematous skin lesions with necrotic centers on lower extremities due to the use of ruxolitinib for primary myelofibrosis. [2021]Ruxolitinib is a small molecule JAK-2 inhibitor approved for the treatment of certain myeloproliferative neoplasms. Ruxolitinib-related skin toxicity is extremely rare. We report herein an unusual erythematous skin eruption with necrotic centers involving lower extremities in a patient with primary myelofibrosis treated with ruxolitinib. Awareness of this unusual skin toxicity with ruxolitinib becomes even more important as JAK-2 inhibition might soon find clinical applications in dermatology.
Results from oral gavage carcinogenicity studies of ruxolitinib in Tg.rasH2 mice and Sprague-Dawley (Crl:CD) rats. [2021]Ruxolitinib is a selective and potent inhibitor of Janus kinase (JAK) 1 and JAK2. It is approved for the treatment of patients with intermediate or high-risk myelofibrosis, or those with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. To investigate its carcinogenic potential, ruxolitinib was administered by oral gavage once daily to Tg.rasH2 mice for 6 months at doses of 15, 45 or 125 mg/kg/day, and to Sprague-Dawley (Crl:CD) rats for 2 years at 10, 20 or 60 mg/kg/day. Ruxolitinib had no effect on survival, and did not increase the incidence of any neoplastic findings in either species. Exposure (AUC) was similar to or exceeded that associated with therapeutic use. Lymphoid depletion and a decrease in extramedullary hematopoiesis in the spleen occurred in rats, which were attributed to the pharmacologic activity of ruxolitinib. In Tg.rasH2 mice, increased inflammation in the nasal cavity was observed. Dose-dependent decreases in a number of spontaneous neoplastic/preneoplastic lesions were observed in rats, including mammary tumors in females, adrenal pheochromocytomas in males, hepatocellular adenomas/carcinomas in males, and hepatic basophilic (males and females) and eosinophilic (males) foci. Peribiliary fibrosis was also decreased. Clear cell foci in the liver were increased in females. Based on the results of these studies, ruxolitinib is not considered to be carcinogenic.
Off-label Studies on the Use of Ruxolitinib in Dermatology. [2021]Ruxolitinib (Jakafi) is a Janus kinase 1 and 2 small molecule inhibitor that the Food and Drug Administration approved for myelofibrosis and polycythemia vera. It has been expanded to off-label treatment for a variety of dermatologic conditions, with several clinical trials ongoing. A review of available studies and cases of off-label uses was performed to guide clinicians seeking evidence on the efficacy of this Janus kinase inhibitor for dermatologic disorders.