Ruxolitinib Cream for Prurigo

(TRuE-PN1 Trial)

No longer recruiting at 113 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Psoralen, Ultraviolet therapy

Disqualifiers: Active dermatitis, Uncontrolled thyroid, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a cream called Ruxolitinib for individuals with Prurigo Nodularis (PN), a skin condition that causes itchy, hard bumps. Participants will use either the Ruxolitinib cream or a placebo to determine its effectiveness in reducing symptoms. It suits those who have had PN for at least three months and have six or more itchy bumps on at least two different body parts. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that certain prohibited medications require a washout period (time without taking them) before participating. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Ruxolitinib cream is generally safe for use. Studies have found that this cream rarely causes serious side effects when used for skin conditions like atopic dermatitis (a type of eczema) and prurigo nodularis (itchy skin lumps).

Past reports noted only mild reactions at the application site, and no new safety issues emerged. The safety profile of the 1.5% Ruxolitinib cream aligns with earlier results, indicating it is well-tolerated over time.

These findings reassure those considering participation in a clinical trial for Ruxolitinib cream. ^{1 2 3 4 5}

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

Unlike traditional treatments for prurigo, which often involve systemic medications or topical steroids, Ruxolitinib cream offers a targeted approach by directly applying a Janus kinase (JAK) inhibitor to the affected skin areas. This method focuses on reducing inflammation and itchiness at the source, potentially providing relief with fewer side effects than oral medications. Researchers are excited because this topical delivery could mean fewer systemic side effects and a more convenient treatment option for patients, especially those who are concerned about long-term steroid use.

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

Research has shown that Ruxolitinib cream, which participants in this trial may receive, can help reduce itching in people with prurigo nodularis. One study found noticeable itch relief by Day 7, with 22.4% of users feeling better compared to only 8% using a placebo cream. The cream has proven safe and effective for long-term use in conditions like atopic dermatitis and prurigo nodularis, with few side effects. Many patients experienced quick itch relief that continued with ongoing use. These findings suggest that Ruxolitinib cream could be a promising option for managing symptoms of prurigo nodularis. ^{1 2 3 5 6}

Who Is on the Research Team?

Haq Nawaz, md

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with Prurigo Nodularis (PN) who've had it for at least 3 months, have a moderate to severe itchiness score, and multiple itchy lesions in different body areas. Participants must not be pregnant or planning pregnancy and should avoid excessive UV exposure. Those with other skin conditions, uncontrolled thyroid issues, recent drug addiction history, or taking certain medications are excluded.

Inclusion Criteria

I have been diagnosed with peripheral neuropathy for at least 3 months.

You have a score of 2 or higher on the IGA-CPG-S test at the initial and follow-up screenings.

Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Over 20% of my body, excluding my head, needs treatment.

My thyroid function is not under control.

Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants apply ruxolitinib or vehicle cream to affected areas twice daily for 12 weeks

12 weeks

Open-Label Extension

Participants apply ruxolitinib cream to active PN-affected areas for up to 40 weeks

40 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
• Vehicle Cream

Trial Overview The study is testing Ruxolitinib cream's safety and effectiveness against a placebo (Vehicle Cream) in treating PN. Participants will apply the creams to see if there's an improvement in their condition compared to those using the non-active cream.

How Is the Trial Designed?

Group I: Ruxolitinib 1.5% Cream Experimental Treatment 1 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 apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.

Group II: Vehicle Cream BID Placebo Group 1 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 apply ruxolitinib 1.5% cream topically during 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

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, 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]

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 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]

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]

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]

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 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]

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-results-phase-3-clinical-trials-evaluating

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

3. dermatologytimes.com dermatologytimes.com/view/ruxolitinib-cream-shows-promise-in-prurigo-nodularis-at-eadv-2025

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 ...

4. incytemi.com incytemi.com/document/Poster/EADV%202025_St%C3%A4nder_Wk%2024%20TRuE-PN1%20TRuE-PN2%20Pooled%20Results.pdf

Efficacy and Safety of Ruxolitinib Cream in Patients With ... Efficacy and safety of ruxolitinib cream in patients with prurigo nodularis: results from a phase. 3, randomized, vehicle-controlled study ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05764161?term=OPZELURA&rank=7

A Study to Evaluate the Efficacy and Safety 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 ...

6. 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 ... ○ The overall safety profile of 1.5% ruxolitinib cream in the TRuE-PN clinical trial program was consistent with previous data, and no new ...