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Janus Kinase (JAK) Inhibitor
Ruxolitinib cream for Atopic Dermatitis
Phase 2
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 4 and 8
Awards & highlights
Study Summary
This trial is testing a new cream for people with atopic dermatitis on their head and/or neck. The cream will be compared to a placebo cream to see if it is more effective and safe. If it is, people will use it for 4 more weeks to see if it helps in the long term.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 2, 4 and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 4 and 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Double-Blind Period: Proportion of participants who achieve an EASI75 of the head and neck region
Secondary outcome measures
Number of treatment-related adverse events
Proportion of participants who achieve an EASI75 of the head and neck region
Proportion of participants who achieve overall EASI75
Trial Design
2Treatment groups
Experimental Treatment
Group I: Open Label Extension: Ruxolitiib cream 1.5%Experimental Treatment1 Intervention
Patients will be treated with Ruxoltinib cream 1.5% twice per day (BID) during the open label extension period. Participants who complete the double-blind period will continue into this open-label extension period for an additional 4 weeks of treatment.
Group II: Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BIDExperimental Treatment2 Interventions
Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib cream
2022
Completed Phase 3
~1850
Vehicle
2013
Completed Phase 3
~5070
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
367 Previous Clinical Trials
55,330 Total Patients Enrolled
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your condition of AD (Atopic Dermatitis) has been unstable in the past month, either getting better on its own or getting worse quickly.You have a BSA of at least 0.5% of the total BSA on the face and/or neck.You have already been treated with certain medications called JAK inhibitors.You have been diagnosed with Alzheimer's disease for at least 6 months.You have a certain type of skin condition called AD that affects up to 20% of your body, including your face, neck, and other areas.You have a skin condition called atopic dermatitis that affects at least 0.5% of your face and/or neck.You have conditions that weaken your immune system, ongoing infections that need strong medications, active skin infections, other skin problems that may affect the evaluation of atopic dermatitis or put you at risk, other types of eczema, or severe asthma that needs a lot of corticosteroid inhalers.Up to 20% BSA (face and/or neck plus other body areas) of the total body surface area.You have an overall and/or a face and/or neck IGA score of 2 or 3 at screening and baseline.There are additional requirements that must be met to participate in the study.You agree to not get pregnant or father a child during the study based on the rules given in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID
- Group 2: Open Label Extension: Ruxolitiib cream 1.5%
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Nevada
California
How old are they?
65+
What site did they apply to?
Science
What portion of applicants met pre-screening criteria?
Met criteria
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