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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 belowSelect...
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
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 • NCT048393806%
COVID-19
4%
Back pain
4%
Headache
4%
Nasopharyngitis
4%
Upper respiratory tract infection
2%
Acne
2%
Concussion
2%
Urinary tract infection
2%
Epistaxis
2%
Eye pruritus
2%
Gastroenteritis
2%
Molluscum contagiosum
2%
Rhinitis allergic
2%
Wound haemorrhage
100%
80%
60%
40%
20%
0%
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
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.
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
388 Previous Clinical Trials
63,535 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My itchiness level is 4 or higher.I have been diagnosed with active atopic dermatitis.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.I have had PUVA treatment within the last 4 weeks.3-20% of my skin, except my scalp, is affected by atopic dermatitis.I stopped taking a JAK inhibitor due to side effects or intolerance.I have had Alzheimer's disease for at least 2 years.I have not used JAK inhibitors in the last 4 weeks.You have a score of 2 or higher on the IGA test during screening and baseline visits.I have not used UVB phototherapy or excimer laser in the last 4 weeks.I am willing to record my daily itch levels at the same time every day during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group: Ruxolitinib
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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