Ruxolitinib Cream for Prurigo

No longer recruiting at 22 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Disqualifiers: Chronic pruritus, Active AD lesions, HBV, HCV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called ruxolitinib to determine its safety and ease of use for individuals with Prurigo Nodularis (PN), a skin condition that causes itchy, bumpy spots. Participants will apply the cream to affected areas twice daily. The trial seeks individuals who have had PN for at least three months and have itchy spots on at least two different body parts. The study aims to ensure the cream's effectiveness without causing problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ruxolitinib cream is likely to be safe for humans?

Research has shown that ruxolitinib cream is generally safe for skin application. In studies involving individuals with atopic dermatitis (a type of eczema) and prurigo nodularis (a skin condition with itchy bumps), the cream caused few side effects. Importantly, researchers have not identified any new or serious safety issues. Some users might experience mild reactions at the application site, but these are uncommon. Overall, the safety data suggests that ruxolitinib cream is well-tolerated, making it a promising option for treating prurigo nodularis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Prurigo?

Unlike the standard treatments for prurigo, which often include oral antihistamines and corticosteroids, Ruxolitinib cream offers a novel approach by targeting the JAK-STAT pathway directly in the skin. This pathway is involved in the inflammation and itchiness associated with prurigo, so applying Ruxolitinib cream directly to the skin can potentially reduce symptoms more effectively and with fewer systemic side effects. Researchers are excited about this cream because it not only provides targeted relief but also allows for a more localized treatment option, potentially improving patient compliance and outcomes.

What evidence suggests that ruxolitinib cream might be an effective treatment for Prurigo Nodularis?

Studies have shown that ruxolitinib cream effectively treats prurigo nodularis (PN), a condition causing itchy skin bumps. Earlier research demonstrated significant improvement in itching, with noticeable benefits as soon as one week after starting treatment. Patients using the cream experienced much less itchiness compared to those using a non-medicated cream. The cream is also considered safe for long-term use, making it a promising option for people with PN. Overall, it improves the condition while maintaining low side effects. ^{1 4 5 6 7}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with skin conditions like Prurigo, Prurigo Nodularis, or Atopic Dermatitis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors such as other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

IGA-CPG-S score of ≥ 2 at screening and baseline

Over 25% of my body, excluding my head, is affected and needs treatment.

My average pain score is 7 or higher over the past week.

Exclusion Criteria

I have long-lasting or sudden itchiness not caused by nerve damage.

Acute or chronic active HBV or HCV infection

My condition related to nerve pain is not stable before starting the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply ruxolitinib 1.5% cream BID to pruriginous lesions for 4 weeks

4 weeks

Optional Treatment Extension

Participants may continue applying ruxolitinib 1.5% cream BID for an additional 4 weeks if no safety concerns are present

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib Cream

Trial Overview

The trial is testing Ruxolitinib Cream at a concentration of 1.5% to see how safe and tolerable it is when used to its maximum recommended amount by people with Prurigo Nodularis (PN).

How Is the Trial Designed?

Group I: Maximal Use Ruxolitinib 1.5% Experimental Treatment 1 Intervention

Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.

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

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Published Research Related to This Trial

Ruxolitinib cream, a topical treatment for atopic dermatitis, was found to be generally well tolerated in a study of 41 patients aged 12 to 65, with only 31.7% experiencing treatment-emergent adverse events, and only 9.8% reporting treatment-related adverse events.

The cream demonstrated high efficacy, with 94.6% of patients achieving at least a 75% improvement in their eczema severity after 56 days of treatment, while the mean plasma concentration of the drug remained well below levels that could cause harmful effects on bone marrow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. Bissonnette, R., Call, RS., Raoof, T., et al.[2022]

In phase II clinical trials, patients using 1.5% topical ruxolitinib (RUX) showed a significant improvement in Eczema Area and Severity Index (EASI) scores after 4 weeks, with a mean improvement of 71.6% compared to only 15.5% for the placebo group (P < 0.001).

Phase III trials demonstrated that a higher percentage of patients treated with 0.75% and 1.5% topical RUX achieved clear or almost clear skin (IGA score of 0 or 1) after 8 weeks, significantly outperforming the placebo (15.1% and 7.6% respectively, P < 0.001), indicating its efficacy in managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Ruxolitinib in the Treatment of Atopic Dermatitis. Mohney, LA., Singh, R., Feldman, SR.[2023]

In two phase 3 trials involving 1249 patients with atopic dermatitis, ruxolitinib cream showed rapid and significant reductions in itch, with over 16% of patients experiencing a 2-point reduction within 12 hours compared to only 6.9% with the vehicle cream.

By Day 2, a greater percentage of patients using ruxolitinib cream achieved a 4-point reduction in itch severity, with sustained improvements observed over the 8-week treatment period, indicating both efficacy and a quick onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. Blauvelt, A., Kircik, L., Papp, KA., et al.[2023]

In two phase 3 studies involving 1249 patients with atopic dermatitis, ruxolitinib cream significantly improved treatment outcomes compared to a vehicle cream, with 93.4% of patients using the 0.75% formulation and 90.9% using the 1.5% formulation achieving clinically meaningful responses by week 8.

Patients who continued using ruxolitinib cream beyond 8 weeks showed progressive improvements, with over half achieving treatment success by week 52, indicating that extended therapy can provide additional benefits and that the cream was well tolerated throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Simpson, EL., Kircik, L., Blauvelt, A., et al.[2023]

Topical ruxolitinib has been shown to improve various dermatological conditions, including atopic dermatitis, vitiligo, psoriasis, and lichen planus, based on a review of 24 studies involving 2618 patients.

The safety profile of topical ruxolitinib is favorable, with minimal bioavailability and low rates of mild-to-moderate side effects, making it a more tolerable option compared to systemic Janus kinase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Topical Ruxolitinib in Dermatology: A Review. Kashetsky, N., Turchin, I.[2023]

Ruxolitinib, a Janus kinase inhibitor approved for myelofibrosis and polycythemia vera, shows promising efficacy in treating dermatologic conditions like atopic dermatitis, psoriasis, and vitiligo, based on data from clinical trials.

The evidence for ruxolitinib's effectiveness in alopecia areata is mixed, varying between topical and oral formulations, indicating the need for further research to clarify its role in treating various skin disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-label Studies on the Use of Ruxolitinib in Dermatology. Tegtmeyer, K., Ravi, M., Zhao, J., et al.[2021]

Ruxolitinib cream 1.5% significantly improved disease severity, itching, and sleep disturbance in patients aged 12 and older with mild to moderate atopic dermatitis after 8 weeks of treatment, and continued to control symptoms for an additional 44 weeks when applied as needed.

The cream was well tolerated, with a safety profile similar to that of a placebo, and infrequent local side effects, making it a promising alternative to traditional treatments like corticosteroids for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. Hoy, SM.[2023]

Ruxolitinib, a JAK-2 inhibitor used for treating myeloproliferative neoplasms, is generally associated with very rare skin toxicity, but an unusual case of erythematous skin eruption with necrotic centers was observed in a patient with primary myelofibrosis.

This case highlights the need for increased awareness of potential skin side effects from ruxolitinib, especially as JAK-2 inhibitors may be used more widely in dermatological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erythematous skin lesions with necrotic centers on lower extremities due to the use of ruxolitinib for primary myelofibrosis. Dasanu, CA.[2021]

Citations

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Incyte Announces Results of Phase 3 Clinical Trials ...

Significant itch improvements were observed with ruxolitinib cream 1.5% versus vehicle control at Day 7 (22.4% vs 8.0%; P=0.0064), with ...

2.

ajmc.com

ajmc.com/view/ruxolitinib-cream-shows-long-term-safety-in-ad-potential-for-pn-treatment

Ruxolitinib Cream Shows Long-Term Safety in AD ...

Ruxolitinib cream is effective for atopic dermatitis and prurigo nodularis, with low adverse event rates in long-term use. The cream reduces the ...

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incytemi.com

incytemi.com/document/Poster/AAD%202025_Kwatra_TRuE-PN1_Rux%20Cream%20in%20PN%20Phase%203%20Results%20(1).pdf

Efficacy and Safety of Ruxolitinib Cream in Patients With ...

... Prurigo; IGA-CPG-S-TS, IGA-CPG-S treatment success (IGA-CPG-S score of 0 or 1 with a ≥2-grade improvement from baseline); OLE, open-label ...

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Ruxolitinib Cream Shows Promise in Prurigo Nodularis at ...

Ruxolitinib cream demonstrated significant itch reduction in TRuE-PN1, with early benefits and sustained improvements in the open-label ...

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Ruxolitinib Cream Is Effective, Safe for Early Treatment of ...

Topical ruxolitinib cream 1.5% for 24 weeks was significantly associated with disease improvement among patients with prurigo nodularis.

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investor.incyte.com

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The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data, and no new safety signals were observed. No serious infections, ...

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A Study to Evaluate the Safety and Efficacy of Ruxolitinib ...

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN). Detailed Description. The ...