What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and JAK inhibitors (such as Ruxolitinib). Topical corticosteroids can cause skin thinning, stretch marks, and increased risk of skin infections. Calcineurin inhibitors may lead to burning sensations, itching, and increased risk of skin infections. JAK inhibitors, like Ruxolitinib, can cause mild side effects such as application site reactions, headaches, and increased blood creatine phosphokinase levels. More severe but less common side effects include infections and changes in blood cell counts.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, including topical corticosteroids, calcineurin inhibitors like tacrolimus and pimecrolimus, and more recently, biologics such as dupilumab, which targets the IL-4 receptor. In the realm of Janus kinase (JAK) inhibitors, which include Ruxolitinib Cream, the FDA has approved topical delgocitinib and oral JAK inhibitors like upadacitinib and abrocitinib for moderate-to-severe Atopic Dermatitis. These treatments work by modulating the immune response to reduce inflammation and alleviate symptoms.

What other types of research exist?

Promising novel alternatives to Ruxolitinib Cream for Atopic Dermatitis patients include Abrocitinib and Upadacitinib, both of which are JAK inhibitors. Additionally, biologics such as Tralokinumab and Dupilumab have shown efficacy in recent clinical trials.

← Back to Search

Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Atopic Dermatitis/Eczema (MORPHEUS Trial)

Phase 4

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an Itch NRS score ≥ 4 at the screening and baseline visits.

Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria.

Must not have

Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study.

Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, Ruxolitinib may commonly cause application site reactions such as itching or redness, potential infection risk increase due to immune response alteration, headaches, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My itchiness level is 4 or higher.

Select...

I have been diagnosed with active atopic dermatitis.

Select...

3-20% of my skin, except my scalp, is affected by atopic dermatitis.

Select...

I have had Alzheimer's disease for at least 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had PUVA treatment within the last 4 weeks.

Select...

I stopped taking a JAK inhibitor due to side effects or intolerance.

Select...

I have not used JAK inhibitors in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Total Sleep Time (TST)

Secondary study objectives

Change from baseline in PROMIS Sleep Disturbance

Side effects data

From 2022 Phase 2 trial • 49 Patients • NCT04839380

COVID-19

Back pain

Headache

Nasopharyngitis

Upper respiratory tract infection

Acne

Concussion

Urinary tract infection

Epistaxis

Eye pruritus

Gastroenteritis

Molluscum contagiosum

Rhinitis allergic

Wound haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 1.5% Cream BID

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment Group: RuxolitinibExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ruxolitinib cream

2021

Completed Phase 2

~50

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atopic Dermatitis (AD) treatments target the underlying inflammation and immune dysregulation. JAK inhibitors like Ruxolitinib block Janus kinase pathways, reducing cytokine signaling involved in inflammation. Corticosteroids suppress a broad range of inflammatory responses by inhibiting multiple cytokines. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, specifically inhibit T-cell activation, reducing inflammation. Biologics like Dupilumab target specific interleukins (IL-4 and IL-13) involved in the inflammatory process. These treatments are crucial for AD patients as they help control severe symptoms, reduce flare-ups, and improve quality of life by addressing the root causes of inflammation.