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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
Must not have
Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib)
Current and/or history of arterial or venous thrombosis, including DVT and PE
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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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I have had Alzheimer's disease for at least 2 years.
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My skin condition hasn't improved with prescribed creams or they're not recommended for me.
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I have been diagnosed with Atopic Dermatitis according to specific criteria.
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My Alzheimer's disease has been diagnosed for at least 2 years.
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I have been diagnosed with Atopic Dermatitis.
Select...
3% to 20% of my body, except my head, is affected by atopic dermatitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken medication for inflammation or cancer that targets my immune system.
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I have had blood clots in my arteries or veins.
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I haven't taken strong CYP3A4 inhibitors recently.
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I do not have active or untreated latent tuberculosis.
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I haven't taken any experimental drugs recently or am not currently in another drug study.
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I haven't had cancer, except for non-spreading skin cancer, in the last 5 years.

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Treatment-emergent adverse events (TEAEs)
Secondary study objectives
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 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638
9%
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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.

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
391 Previous Clinical Trials
63,732 Total Patients Enrolled
Brett Angel, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
330 Total Patients Enrolled

Media Library

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05456529 — Phase 3
Atopic Dermatitis Research Study Groups: Ruxolitinib
Atopic Dermatitis Clinical Trial 2023: Ruxolitinib Cream Highlights & Side Effects. Trial Name: NCT05456529 — Phase 3
Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456529 — Phase 3
~33 spots leftby Nov 2025
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