Ruxolitinib Cream for Lichen Planus

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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the effectiveness and safety of Ruxolitinib cream for people with Cutaneous Lichen Planus. The cream is applied to the skin and works by blocking enzymes that cause inflammation. The study will compare the cream to another treatment over several months, followed by a period where all participants use the cream. Ruxolitinib cream has been previously tested and shown potent anti-inflammatory and antipruritic efficacy in atopic dermatitis.

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.

What data supports the effectiveness of the drug Ruxolitinib Cream for treating lichen planus?

A study showed that Ruxolitinib Cream, which blocks certain proteins involved in inflammation, reduced the number of skin lesions in patients with lichen planus after 8 weeks of use. Additionally, Ruxolitinib Cream has been effective in reducing symptoms in other skin conditions like atopic dermatitis, suggesting it may help with lichen planus as well. ^{1 2 3 4 5}

Is Ruxolitinib Cream safe for use in humans?

Ruxolitinib cream has been used safely in various skin conditions like atopic dermatitis and lichen planus, with minimal side effects such as occasional mild skin irritation. It is generally well-tolerated, with a safety profile similar to other topical treatments, and serious side effects are rare. ^{1 3 4 6 7}

How is ruxolitinib cream different from other drugs for lichen planus?

Ruxolitinib cream is unique because it is a topical treatment that specifically targets Janus kinase 1 and 2, which are involved in the inflammation process of lichen planus. This makes it different from other treatments like corticosteroids, as it directly blocks the signals that cause inflammation, potentially offering a more targeted approach with fewer systemic side effects. ^{1 2 3 5 7}

Research Team

Haq Nawaz, MD

Principal Investigator

Incyte Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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, 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Off-label Studies on the Use of Ruxolitinib in Dermatology. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Canada pubmed.ncbi.nlm.nih.gov

Utilization of Topical Ruxolitinib in Dermatology: A Review. [2023]