Ruxolitinib Cream for Atopic Dermatitis/Eczema

(MORPHEUS Trial)

No longer recruiting at 39 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called ruxolitinib to determine if it can help people with atopic dermatitis (a type of eczema) sleep better. Researchers aim to find out if applying this cream twice daily can reduce sleep disturbances related to this skin condition. Individuals who have had eczema for at least two years and experience itching may be suitable for this study. Participants must follow a regular sleep schedule and refrain from using sleep-tracking devices during the trial. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Ruxolitinib Cream?

Research shows that ruxolitinib cream is generally safe and effective. It has proven effective in treating atopic dermatitis, a common form of eczema. In some studies, participants used the cream for 8 weeks without major safety issues.

In another study, more than half of those with nonatopic hand eczema improved, indicating the cream's safety for various eczema types. Another study highlighted its particular safety for mild to moderate eczema.

Since this trial is in a later stage, the cream has already undergone extensive testing, which supports its safety. Always consult a healthcare provider before joining a clinical trial to ensure it is the right choice. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ruxolitinib cream is unique because it offers a targeted approach to treating atopic dermatitis, a condition typically managed with topical corticosteroids or calcineurin inhibitors. Unlike these standard treatments, ruxolitinib is a Janus kinase (JAK) inhibitor, which directly interferes with specific pathways involved in inflammatory responses. This targeted action may reduce inflammation and itching with potentially fewer side effects than broad-spectrum treatments. Researchers are excited about this cream because it could provide faster and more efficient relief for eczema sufferers, possibly improving skin condition in just a few days.

What is the effectiveness track record for Ruxolitinib Cream in treating atopic dermatitis?

Research shows that ruxolitinib cream effectively treats atopic dermatitis, a common form of eczema. Studies have found that this cream can clear up the skin and improve symptoms quickly, often by the second week. Many people notice a significant reduction in itching and an improved quality of life. These benefits can last up to a year with regular use. Participants in this trial will receive ruxolitinib cream, already approved for treating atopic dermatitis, confirming its effectiveness in managing this condition. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-new-data-phase-3b-true-ad4-trial-opzelurar

Incyte Announces New Data from Phase 3b TRuE-AD4 ... Eight-week results from the TRuE-AD4 trial demonstrate treatment with Opzelura® (ruxolitinib cream) significantly improved the clinical ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39546129/

Ruxolitinib Cream Monotherapy Improved Symptoms and ... Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks.

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

Efficacy and safety of ruxolitinib cream for the treatment ... The majority of patients who applied ruxolitinib cream achieved clear or almost clear skin (IGA-CHE 0/1) accompanied by a ≥2-grade improvement ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950312425000028

Therapeutic efficacy and safety of topical ruxolitinib in mild- ... Ruxolitinib significantly improves atopic dermatitis symptoms. It is a safe and effective treatment, especially for patients with mild-to-moderate disease ...

5. link.springer.com link.springer.com/article/10.1007/s13555-024-01272-3

Efficacy and Safety of Ruxolitinib Cream in Atopic ... Ruxolitinib cream monotherapy was associated with rapid reductions in signs and symptoms of mild to moderate AD and long-term disease control, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36574595/

Long-term safety and disease control with ruxolitinib cream ... Ruxolitinib cream demonstrated safety and efficacy over 8 weeks in 2 double-blind phase 3 atopic dermatitis studies.

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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06238817

NCT06238817 | A Study to Evaluate the Efficacy, and ... A study to evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis ...