Ruxolitinib Cream for Atopic Dermatitis/Eczema

(MORPHEUS Trial)

Recruiting at 37 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Incyte Corporation

Must not be taking: JAK inhibitors

Disqualifiers: Nighttime work, Unstable AD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Duration: 8 weeks

47 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a skin cream called ruxolitinib to see if it can help people with Atopic Dermatitis sleep better by reducing inflammation and itching. Ruxolitinib cream is used to treat inflammatory skin diseases like atopic dermatitis.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you have had significant changes in your AD medications in the last 4 weeks, you may not be eligible.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using JAK inhibitors or have had significant changes in your medications recently, you may not be eligible to participate.

What data supports the idea that Ruxolitinib Cream for Atopic Dermatitis/Eczema is an effective treatment?

The available research shows that Ruxolitinib Cream is effective for treating atopic dermatitis. In two large studies, patients aged 12 and older with mild to moderate atopic dermatitis who used Ruxolitinib Cream saw improvements in their condition, including less severe symptoms, reduced itching, and better sleep, compared to those using a non-medicated cream. These benefits lasted for 44 weeks when the cream was used as needed. Additionally, the cream was well tolerated, with few side effects like stinging or burning. Compared to other treatments like corticosteroids, Ruxolitinib Cream offers a new option with a good safety profile. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Ruxolitinib Cream for treating atopic dermatitis?

Research shows that Ruxolitinib Cream, a topical medication, significantly improved skin condition, itching, and sleep issues in people with mild to moderate atopic dermatitis when used for 8 weeks. It was well tolerated and provided an alternative to other topical treatments like corticosteroids. ^{1 2 3 4 5}

What safety data exists for Ruxolitinib Cream in treating atopic dermatitis?

Ruxolitinib cream 1.5% has been evaluated in phase III studies for mild to moderate atopic dermatitis, showing it is well tolerated with a safety profile similar to vehicle cream. Adverse events were typical and infrequent, with no systemic JAK inhibition safety concerns identified. It is considered to have a favorable safety profile for treating atopic dermatitis. ^{1 2 3 4 6}

Is Ruxolitinib Cream safe for use in humans?

Ruxolitinib cream has been shown to be generally safe for humans, with a safety profile similar to a placebo cream in studies for atopic dermatitis. Some mild skin reactions like stinging or burning were infrequent, and no serious safety concerns were identified. ^{1 2 3 4 6}

Is Ruxolitinib Cream a promising drug for treating atopic dermatitis?

Yes, Ruxolitinib Cream is a promising drug for treating atopic dermatitis. It has shown to improve skin condition, reduce itching, and help with sleep problems in people with mild to moderate atopic dermatitis. It works well and is safe to use, providing an alternative to other treatments like corticosteroids. ^{1 2 3 4 5}

How is the drug Ruxolitinib Cream different from other treatments for atopic dermatitis?

Ruxolitinib Cream is unique because it is the first FDA-approved topical JAK inhibitor specifically for atopic dermatitis, targeting specific enzymes (JAK1 and JAK2) involved in the inflammation process, which is different from traditional treatments like corticosteroids and calcineurin inhibitors. ^{1 2 3 4 5}

Eligibility Criteria

Adults with a history of Atopic Dermatitis (AD) for at least 2 years, experiencing sleep disturbances due to AD. They must have an affected body surface area of 3%-20% and an Itch score ≥4. Participants should not have had significant AD flares or treatment changes in the past month, no recent JAK inhibitor use, and cannot work night shifts.

Inclusion Criteria

My itchiness level is 4 or higher.

I have been diagnosed with active atopic dermatitis.

Agrees to maintain a regular sleep schedule during the study period.

Exclusion Criteria

I have not used any experimental drugs or devices in the last 4 weeks.

My skin condition has significantly worsened or needed medication changes in the last 4 weeks.

Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply ruxolitinib cream 1.5% twice daily as a thin film

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ruxolitinib Cream

Trial Overview The trial is testing Ruxolitinib cream's effectiveness on improving sleep in adults with Atopic Dermatitis. The study requires participants to maintain a regular sleep schedule and follow procedures for measuring their sleep throughout the study period.

Participant Groups

Group I: Treatment Group: Ruxolitinib Experimental Treatment 1 Intervention

ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.

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 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]

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]

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, 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]

References

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

Review of Ruxolitinib in the Treatment of Atopic Dermatitis. [2023]

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

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

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

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

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

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