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Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream for Eczema
Phase 3
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Duration of AD of at least 2 years
Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)
Awards & highlights
Study Summary
This trial will test the safety of a new cream for teens with Atopic Dermatitis.
Who is the study for?
Adolescents with Atopic Dermatitis (AD) covering 3-20% of their body, not including the scalp. They must have had AD for at least two years and found no relief from other topical prescriptions. Participants should be willing to stop using all other AD treatments during the study and take precautions to avoid pregnancy.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib Cream's long-term safety and effectiveness in treating adolescents with Atopic Dermatitis. The cream's ability to manage symptoms over an extended period will be closely monitored.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be observed for any adverse reactions to Ruxolitinib Cream throughout the trial to assess its tolerability.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had Alzheimer's disease for at least 2 years.
Select...
My skin condition hasn't improved with prescribed creams or they're not recommended for me.
Select...
I have been diagnosed with Atopic Dermatitis according to specific criteria.
Select...
My Alzheimer's disease has been diagnosed for at least 2 years.
Select...
I have been diagnosed with Atopic Dermatitis.
Select...
3% to 20% of my body, except my head, is affected by atopic dermatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values
Number of participants with clinically notable vital sign changes from baseline
Number of participants with clinically significant changes from Baseline in height
+2 moreSide effects data
From 2020 Phase 3 trial • 631 Patients • NCT037456389%
Upper respiratory tract infection
6%
Nasopharyngitis
4%
Headache
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 0.75% Cream BID
Vehicle Cream BID
Ruxolitinib 1.5% Cream BID
Trial Design
1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,062 Total Patients Enrolled
Brett Angel, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
329 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had blood clots in my arteries or veins.Your total IGA score is between 2 and 3 during the screening and baseline visits.I haven't been exposed to a lot of UV light from the sun or tanning beds in the last 2 weeks.I do not have active or untreated latent tuberculosis.My skin condition hasn't improved with prescribed creams or they're not recommended for me.I haven't taken strong CYP3A4 inhibitors recently.I haven't taken any experimental drugs recently or am not currently in another drug study.I have had Alzheimer's disease for at least 2 years.I have taken medication for inflammation or cancer that targets my immune system.I have stopped using certain medications for the required time before starting this trial.Unable to take blood samples for testing from areas without any skin issues.I have been diagnosed with Atopic Dermatitis according to specific criteria.3% to 20% of my skin, excluding my scalp, is affected by eczema.My Alzheimer's disease has been diagnosed for at least 2 years.My skin condition hasn't improved with prescribed creams or they're not recommended for me.I have been diagnosed with Atopic Dermatitis.I agree to stop all current Alzheimer's treatments during the study.Your Alzheimer's disease has been getting worse or better quickly in the 4 weeks before the study starts.You have a specific score on a test called IGA at the screening and baseline visits.I have other health conditions or a history of other diseases.I haven't had cancer, except for non-spreading skin cancer, in the last 5 years.Your blood tests show low hemoglobin, abnormal liver function, poor kidney function, positive HIV test, or any other serious abnormal lab results that could be risky for you.3% to 20% of my body, except my head, is affected by atopic dermatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new study participants still being accepted at this time?
"From what is available on clinicaltrials.gov, it appears that this particular trial is still looking for participants. The earliest date when information about the study was published was September 1st, 2022 and the most recent update was on November 8th, 2022."
Answered by AI
How many people are signing up for this clinical trial?
"Yes, you are correct. The information available on clinicaltrials.gov does show that this study is looking for more participants. It was originally posted on September 1st, 2022 and edited November 8th, of the same year. They are hoping to enroll 100 patients from 29 different locations."
Answered by AI
How can I sign up to participate in this research project?
"This dermatitis study, which needs 100 participants that are aged 12-17, has strict inclusion criteria. Some of the more notable requirements are as follows: The patient's AD must have lasted for a minimum of 2 years, They must have an IGA score of 2-3 at screening and baseline visits, 3-20% BSA (excluding scalp), A diagnosis of Atopic dermatitis according to Hanifin and Rajka (1980), Must be willing to discontinue all other AD treatments from screening until final follow up visit, Be willing to avoid pregnancy or fathering children during the trial."
Answered by AI
In how many different locations is this research being conducted?
"Along with 29 other research facilities, this study is taking place at Peninsula Research Associates Pra in Rolling Hills Estates, California, Skin Specialists Pc the Advanced Skin Research Center in Omaha, Nebraska, and Sneeze Wheeze and Itch Associates Llc in Normal, Illinois."
Answered by AI
Is Ruxolitinib Cream unsafe for human use?
"There is some data to support the efficacy of Ruxolitinib Cream, as this is a Phase 3 trial. Furthermore, because there have been multiple rounds of testing supporting its safety, our team has given it a score of 3."
Answered by AI
Does this specific research project have an age requirement for participants?
"This trial, which has 111 similar trials for patients aged 12-17 and 181 for those over 65, requires that participants be under the age of 18."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Advanced Rx Clinical Research Group, Inc
Encore Medical Research, Llc Hollywood
Acevedo Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to feel better.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Most responsive sites:
- Advanced Rx Clinical Research Group, Inc: < 24 hours
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