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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

MORPHEUS Trial Summary

This trial tests a cream to see if it helps people with Atopic Dermatitis get better sleep.

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.Check my eligibility
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.See study design
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.

MORPHEUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My itchiness level is 4 or higher.
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I have been diagnosed with active atopic dermatitis.
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3-20% of my skin, except my scalp, is affected by atopic dermatitis.
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I have had Alzheimer's disease for at least 2 years.
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I am willing to record my daily itch levels at the same time every day during the study.

MORPHEUS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Total Sleep Time (TST)
Secondary outcome measures
Change from baseline in PROMIS Sleep Disturbance

Side effects data

From 2022 Phase 2 trial • 49 Patients • NCT04839380
6%
COVID-19
4%
Headache
4%
Nasopharyngitis
4%
Back pain
4%
Upper respiratory tract infection
2%
Eye pruritus
2%
Urinary tract infection
2%
Molluscum contagiosum
2%
Acne
2%
Gastroenteritis
2%
Concussion
2%
Epistaxis
2%
Rhinitis allergic
2%
Wound haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 1.5% Cream BID

MORPHEUS 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

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
362 Previous Clinical Trials
54,983 Total Patients Enrolled

Media Library

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05696392 — Phase 4
Atopic Dermatitis Research Study Groups: Treatment Group: Ruxolitinib
Atopic Dermatitis Clinical Trial 2023: Ruxolitinib Cream Highlights & Side Effects. Trial Name: NCT05696392 — Phase 4
Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696392 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What dangers do participants face when given treatment with ruxolitinib?

"Our team has rated Ruxolitinib's safety a 3 based on the fact that this treatment is approved and currently undergoing Phase 4 trials."

Answered by AI

Are more participants needed for this research endeavor?

"Affirmative. The information on clinicaltrials.gov implies that this research project is currently enrolling suitable participants. This trial, which was initially published on January 30th 2023 and amended most recently in mid-January, seeks 100 volunteers at two sites."

Answered by AI

How many participants are currently enrolled in this experiment?

"Affirmative. According to information found on clinicaltrials.gov, this research is currently enrolling participants and has opened up recruitment since January 30th 2023. The last update was made January 13th of the same year with a goal of finding 100 people from two distinct sites."

Answered by AI
~28 spots leftby Sep 2024