Ruxolitinib Cream for Hand Eczema

Recruiting at 39 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

Trial Summary

What is the purpose of this trial?

This trial is testing a cream called ruxolitinib for adults with chronic hand eczema that is moderate to severe. The cream works by blocking enzymes that cause inflammation, which may help reduce eczema symptoms. The goal is to see if this treatment is safe and effective for these patients.

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.

What data supports the effectiveness of the drug Ruxolitinib cream for hand eczema?

Ruxolitinib cream has shown effectiveness in reducing symptoms of atopic dermatitis, a condition similar to eczema, by significantly improving skin condition and reducing itchiness in patients. This suggests it may also be effective for hand eczema, as both conditions involve inflammation and skin irritation. ^{1 2 3 4 5}

Is Ruxolitinib cream safe for use in humans?

Ruxolitinib cream has been shown to be well tolerated in patients with atopic dermatitis, with a safety profile similar to that of a placebo cream over the short term. Skin-related side effects like stinging or burning were infrequent, and no systemic safety issues were identified. ^{2 4 5 6 7}

How does the drug Ruxolitinib cream differ from other treatments for hand eczema?

Ruxolitinib cream is unique because it is a topical formulation that specifically inhibits Janus kinase (JAK) 1 and JAK2, which are involved in the inflammatory process. This mechanism of action is different from traditional treatments like corticosteroids, offering a targeted approach to reducing inflammation and itchiness in conditions like eczema. ^{1 2 3 4 7}

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

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.

Your skin condition is assessed as moderate to severe.

You have severe itching before starting the study.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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, 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2023]

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

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

4. England 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. [2022]

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

Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. [2022]

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

Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib. [2022]

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

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