Ruxolitinib Cream for Hand Eczema

Recruiting at 40 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Disqualifiers: Serious illness, Pregnancy, Psychiatric condition, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of ruxolitinib cream for individuals with chronic hand eczema, a condition causing dry, itchy, and inflamed skin on the hands. Participants will use either the ruxolitinib cream or a placebo cream for 16 weeks, with an option to switch to the ruxolitinib cream later. The trial suits those who have had hand eczema for at least six months and have tried at least one other prescription treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial mentions a 'washout period' (time without taking certain medications) for some treatments before starting the study, but it doesn't specify which medications. It's best to discuss your current medications with the study team to see if any need to be paused.

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 people with chronic hand eczema. Studies found no new safety issues, indicating that side effects were expected and manageable. Most patients did not experience serious problems and noticed improvements in skin pain and quality of life. This suggests the cream is safe for treating hand eczema. ^{1 2 3 4 5}

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

Ruxolitinib cream is unique for treating hand eczema because it targets the Janus kinase (JAK) pathway, which plays a key role in inflammation. Unlike standard treatments like topical corticosteroids or calcineurin inhibitors, which can have side effects with long-term use, ruxolitinib offers a targeted approach that may reduce such risks. Researchers are excited about its potential to deliver effective results without the drawbacks of traditional therapies, offering a promising new option for managing this condition.

What evidence suggests that ruxolitinib cream might be an effective treatment for hand eczema?

Research has shown that ruxolitinib cream could help treat chronic hand eczema. In this trial, one group of participants will receive ruxolitinib cream. In previous studies, 53.2% of those using the cream achieved clear or almost clear skin. Participants also experienced less skin pain and reported an improved quality of life. The treatment was well tolerated, with no new safety issues. Early evidence suggests this cream might be a safe and effective option for those with moderate to severe symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

Adults with chronic hand eczema (CHE) for at least 6 months, experiencing moderate to severe symptoms. Participants must have had previous CHE treatments or been advised against them and agree to prevent pregnancy or fathering children during the trial. Those with known CHE triggers that can't be avoided, serious health conditions, abnormal lab values, recent use of excluded treatments, or UV therapy on hands are not eligible.

Inclusion Criteria

I have been diagnosed with chronic hand eczema for at least 6 months.

You have severe itching before starting the study.

Your skin condition is assessed as moderate to severe.

Exclusion Criteria

You have known allergic or irritant triggers that cannot be avoided during the study.

Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

Your lab test results don't meet the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ruxolitinib cream 1.5% BID or vehicle cream for 16 weeks

16 weeks

Open-label extension

Participants receive ruxolitinib cream 1.5% BID for an additional 16 weeks

16 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 study is testing Ruxolitinib cream's effectiveness and safety compared to a placebo (vehicle) in adults with chronic hand eczema. The goal is to see if this cream can reduce the severity of their skin condition.

How Is the Trial Designed?

Group I: Ruxolitinib Experimental Treatment 1 Intervention

Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.

Group II: Vehicle Placebo Group 1 Intervention

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

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

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]

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 1.5% cream is the first FDA-approved topical JAK inhibitor for atopic dermatitis (AD), showing high efficacy in treating this chronic skin condition.

The cream has a favorable safety profile, making it a promising new option for patients suffering from the pruritic and inflammatory symptoms of AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib. Owji, S., Caldas, SA., Ungar, B.[2022]

In a pilot study involving 10 patients with mild atopic dermatitis, a topical emulgel containing ruxolitinib significantly improved skin condition, reducing symptoms like itching and burning after four weeks of treatment.

The treatment also enhanced skin hydration and density, indicating good short-term efficacy and tolerability for patients with mild atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of tolerability and efficacy of a topical emulgel containing nanoliposomal ruxolitinib phosphate in the treatment of mild atopic dermatitis: a before-after single group pilot study. Naeimifar, A., Ahmad Nasrollahi, S., Samadi, A., et al.[2022]

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. jaad.org jaad.org/article/S0190-9622(25)02717-3/fulltext

Efficacy and safety of ruxolitinib cream for the treatment ... In this first randomized controlled trial of ruxolitinib cream in chronic, nonatopic hand eczema, most (53.2%) patients achieved clear/almost ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40889714/

Efficacy and safety of ruxolitinib cream for the treatment ... Improvements in skin pain and quality of life were reported during the study. Ruxolitinib cream was well tolerated, with no new safety signals ...

3. academic.oup.com academic.oup.com/bjd/article-abstract/188/Supplement_3/ljad162.012/7202480

384 Ruxolitinib 1.5% cream efficacy data for moderate-to ... Data from 4 weeks interim analysis are encouraging and suggest that ruxolitinib 1.5% may be an effective and well-tolerated treatment for moderate-severe CHD.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05906628

Topical Ruxolitinib Evaluation in Chronic Hand Eczema The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and ...

5. incytemi.com incytemi.com/document/Poster/Fall%20Clinical%202025_Stein%20Gold%20LF_Phase%202%20Rux%20Cream%20CHE%2032-Week%20Data.pdf

Efficacy and Safety of Ruxolitinib Cream for the Treatment ... In patients with nonatopic CHE, 1.5% ruxolitinib cream. BID substantially improved clinical signs, symptoms,.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962225027173

Efficacy and Safety of Ruxolitinib Cream for the Treatment ... Improvements in skin pain and quality of life were reported during the study. Ruxolitinib cream was well tolerated, with no new safety signals ...

7. jaad.org jaad.org/article/S0190-9622(25)02717-3/pdf

Efficacy and safety of ruxolitinib cream for the treatment of ... In this first randomized controlled trial of ruxolitinib cream in chronic, nonatopic hand eczema, most (53.2%) patients achieved clear/almost ...