Ruxolitinib Cream for Prurigo Nodularis

(TRuE-PN2 Trial)

No longer recruiting at 116 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: Chronic pruritus, Active dermatitis, 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 tests a cream called Ruxolitinib to determine its safety and effectiveness for people with Prurigo Nodularis (PN), a skin condition that causes itchy bumps. Participants will apply either the Ruxolitinib cream or a placebo (a look-alike cream with no active ingredient) to their skin for 12 weeks. It suits those who have had PN for at least three months with at least six itchy spots on their body. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Do I need to stop my current medications for the trial?

The trial protocol mentions that certain medications are prohibited unless a washout period (time without taking certain medications) is completed. It is best to discuss your current medications with the trial team to see if they are allowed.

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

Research shows that Ruxolitinib cream is generally safe for treating skin conditions like prurigo nodularis. Studies have found that it rarely causes issues such as redness or irritation at the application site. Importantly, recent research has not identified any new safety concerns. Long-term studies also indicate that the cream is usually well-tolerated, with few negative effects. This suggests that Ruxolitinib cream could be a safe choice for many considering participation in a trial. ^{1 2 3 4 5}

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

Unlike standard treatments for prurigo nodularis, which often include corticosteroids or antihistamines, Ruxolitinib cream works by targeting specific pathways in the immune system. This cream contains ruxolitinib, a Janus kinase (JAK) inhibitor, which can reduce inflammation and itching by blocking the signals that cause these symptoms. Researchers are excited about this treatment because it offers a novel mechanism of action that could provide relief for patients who do not respond well to existing therapies. Additionally, being a topical cream, it offers a more targeted approach with potentially fewer systemic side effects compared to oral medications.

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

Research shows that ruxolitinib cream, which participants in this trial may receive, effectively treats prurigo nodularis (PN), a condition causing itchy skin bumps. Studies have found that this cream significantly reduces itching in PN patients, with improvements starting as soon as Day 7. Specifically, 22.4% of patients experienced itch relief compared to 8% who used a placebo cream, another treatment arm in this trial. The cream also provides lasting benefits, helping to control symptoms over time. Additionally, ruxolitinib cream has been safely used for similar skin conditions like atopic dermatitis, with few side effects. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

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

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

Regular visits for assessment

Open-Label Extension

Participants who completed the double-blind period continue treatment with ruxolitinib cream for up to 40 weeks

40 weeks

Regular visits for assessment

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 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.

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 enter the open label extension (OLE) period for up to 40 weeks.

Group II: Vehicle Cream 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 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

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 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 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 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]

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]

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]

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 JAK1 and JAK2 inhibitor used for myelofibrosis and polycythemia vera, showed no carcinogenic potential in long-term studies with Tg.rasH2 mice and Sprague-Dawley rats, indicating it does not increase cancer risk.

Despite some pharmacological effects like lymphoid depletion and inflammation, ruxolitinib did not affect survival rates or increase neoplastic findings, suggesting it is safe for therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from oral gavage carcinogenicity studies of ruxolitinib in Tg.rasH2 mice and Sprague-Dawley (Crl:CD) rats. Shuey, DL., Oliver, J., Zhou, G., et al.[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]

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. hcplive.com hcplive.com/view/pooled-phase-3-data-on-ruxolitinib-highlights-benefit-in-prurigo-nodularis

Pooled Phase 3 Data on Ruxolitinib Highlights Benefit in ... Ruxolitinib cream demonstrated significant early and sustained improvements in prurigo nodularis symptoms through week 24 in phase 3 trials.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05755438?term=AREA%5BConditionSearch%5D(%22Prurigo%22)&rank=3

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 ...