Ruxolitinib Cream for Lichen Planus

No longer recruiting at 24 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must not be taking: Antibiotics, Antivirals, Antifungals, Antiparasitics

Disqualifiers: Immunocompromised, Active skin infection, others

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: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Ruxolitinib cream to determine its effectiveness for cutaneous lichen planus, a skin condition causing itchy, flat-topped bumps. Researchers aim to assess the cream's safety and efficacy by comparing it to a placebo (a cream with no active medicine) over 16 weeks, followed by another 16-week period where all participants use Ruxolitinib cream. Suitable candidates have cutaneous lichen planus with significant itchiness and no other ongoing skin conditions. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a chronic or acute infection requiring treatment with certain medications, you may need to stop those at least 2 weeks before starting the trial.

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 use. A safety study found mild pain at the application site as the most common side effect, occurring in about 2.7% of users, while no one using a placebo cream reported this pain. Serious side effects were rare.

Ruxolitinib cream has been tested for various skin conditions and has shown promising results. For example, some patients experienced significant improvements in their skin problems. While all treatments carry risks, evidence suggests that Ruxolitinib cream is relatively safe for skin use. ^{1 2 3 4 5}

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

Unlike the standard treatments for lichen planus, which often include corticosteroids and immunosuppressants, Ruxolitinib cream offers a novel approach by targeting the JAK pathway. This mechanism of action is different because it directly interferes with the signaling processes that cause inflammation and lesions in lichen planus. Researchers are excited about Ruxolitinib cream because it not only potentially provides a more targeted treatment but is also applied topically, which may reduce systemic side effects compared to oral medications. This targeted, topical approach could lead to more effective management of symptoms with fewer overall risks.

What evidence suggests that Ruxolitinib cream might be an effective treatment for Lichen Planus?

Research has shown that Ruxolitinib cream may help treat skin lichen planus. In this trial, participants will receive either Ruxolitinib cream with a 1.5% concentration or a vehicle cream with no active ingredients for 16 weeks. Previous studies have demonstrated that Ruxolitinib cream significantly improved the condition compared to a cream with no active ingredients. Specifically, another study found that the cream reduced visible symptoms, improved quality of life, and relieved itching. These results suggest that Ruxolitinib cream could be a good option for managing lichen planus symptoms. ^{3 4 6 7 8}

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 a skin condition called Cutaneous Lichen Planus, who experience itching and have moderate to severe symptoms. Participants must not be pregnant or planning pregnancy and should not have other skin infections or inflammatory conditions that could affect the study results.

Inclusion Criteria

If you have an itch score of 4 or higher before starting the treatment.

Willingness to avoid pregnancy or fathering children

You have an itch score of 4 or higher before starting treatment.

Exclusion Criteria

I have a condition that weakens my immune system.

I have not taken antibiotics or antivirals for infections in the last 2 weeks.

I haven't had skin infections like cold sores, shingles, or impetigo in the past week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind, Vehicle-Controlled Treatment

Participants receive either Ruxolitinib 1.5% cream or vehicle cream BID for 16 weeks

16 weeks

Visits at Weeks 2, 4, 8, 12, and 16

Open-Label Extension

All participants receive Ruxolitinib 1.5% cream BID for an additional 16 weeks

16 weeks

Visits at Weeks 18, 20, 24, 28, and 32

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 study tests Ruxolitinib cream's effectiveness and safety against a placebo (Vehicle cream) in treating Cutaneous Lichen Planus. It starts with a 16-week double-blind phase where neither participants nor researchers know who gets which cream, followed by an open-label phase of another 16 weeks.

How Is the Trial Designed?

Group I: Ruxolitinib cream Experimental Treatment 2 Interventions

Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

Group II: Vehicle Cream Placebo Group 1 Intervention

Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

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]

In a phase II study involving 12 patients, topical ruxolitinib significantly reduced the total lesion count in cutaneous lichen planus by a median of 50 lesions after 8 weeks of treatment, indicating its efficacy.

Transcriptomic analysis revealed that cutaneous lichen planus is driven by interferon pathways, and the treatment with ruxolitinib led to downregulation of interferon-stimulated genes, supporting its mechanism of action in targeting this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. Brumfiel, CM., Patel, MH., Severson, KJ., et al.[2022]

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, 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 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 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]

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]

Citations

1. jaad.org jaad.org/article/S0190-9622(25)01499-9/fulltext

61176 Efficacy of Ruxolitinib Cream in Patients With ... In summary, continuous application of 1.5% ruxolitinib cream BID showed substantial improvement in LP disease severity outcomes versus vehicle, with further ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12445295/

Successful Treatment of Childhood Nail Lichen Planus with ... In our patient, the remarkable results suggest topical ruxolitinib cream may be a potential treatment option for childhood NLP. More case ...

3. ajmc.com ajmc.com/view/topical-ruxolitinib-emerges-as-promising-therapy-for-diverse-inflammatory-skin-conditions

Topical Ruxolitinib Emerges as Promising Therapy for ... Ruxolitinib proved effective for a single patient with morphea in a case series, and it improved pruritus, hyperpigmentation, and erythema.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05593445

NCT05593445 | A Study to Evaluate the Efficacy and ... The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X22000835

Ruxolitinib Cream in the Treatment of Cutaneous Lichen ... In this study, topical ruxolitinib was effective in promptly reducing clinically apparent disease activity, improving QoL and pruritus, and normalizing ISGs in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11974361/

Off‐Label Use of Topical Ruxolitinib in Dermatology Part A showed efficacy of 1.5% ruxolitinib cream with a SALT50 (≥ 50% improvement from baseline in SALT) achieved by 50% of patients at week 24.

7. incytemi.com incytemi.com/document/Poster/Fall%20Clinical%202025_Bunick%20CG_Rux%20Cream%20Integrated%20Safety%20Analysis.pdf

Integrated Safety Analysis of Ruxolitinib Cream Mangold AR, et al. Efficacy and safety of ruxolitinib cream in patients with cutaneous lichen planus: results from a phase 2, randomized, ...

8. investor.incyte.com investor.incyte.com/news-releases/news-release-details/update-fda-review-ruxolitinib-cream-opzelurar-children-ages-2-11

Update on FDA Review of Ruxolitinib Cream (Opzelura® ... The most common treatment-related adverse event among patients treated with Opzelura was application site pain (2.7% vs 0% in vehicle arm). These events were ...