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Janus Kinase Inhibitor

Ruxolitinib Cream for Eczema (TRuE-AD4 Trial)

Phase 3

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Awards & highlights

Pivotal Trial

Summary

This trial aims to determine how effective ruxolitinib cream is for people with moderate atopic dermatitis who did not respond well to or cannot tolerate topical corticosteroids or calcineur

Who is the study for?

Adults over 18 with moderate atopic dermatitis (AD) covering 10-20% of their body, not including the scalp. They must have had AD for at least two years and not responded well to or can't use topical steroids and calcineurin inhibitors. Participants need an IGA score of 3, EASI score above 7, significant itchiness, and a DLQI score over 10.

What is being tested?

The trial is testing Ruxolitinib Cream against a placebo cream (Vehicle Cream) in adults with moderate AD who haven't seen improvement from standard treatments like topical steroids or are unable to use them due to intolerance or contraindications.

What are the potential side effects?

Possible side effects of Ruxolitinib Cream may include application site reactions such as burning or irritation, headaches, increased risk of infections due to immune system effects, and possibly other skin issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 2, 4, 8, 12, 16, 20 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 2, 4, 8, 12, 16, 20 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VC Period: Proportion of participants who achieved Investigator's Global Assessment Treatment Success (IGA-TS)

Secondary study objectives

VC Period: Number of Treatment Emergent Adverse Events (TEAEs)

VC Period: Proportion of participants who achieved Eczema Area and Severity Index 75 (EASI75)

VC Period: Proportion of participants who achieved Investigator's Global Assessment - Treatment Success (IGA-TS)

+21 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638

Upper respiratory tract infection

Nasopharyngitis

Headache

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 0.75% Cream BID

Vehicle Cream BID

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.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: VC Period: Ruxolitinib 1.5% Cream BIDExperimental Treatment1 Intervention

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Group II: VC Extension Period: Ruxolitinib 1.5% cream open-label escape armExperimental Treatment1 Intervention

Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Group III: VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BIDExperimental Treatment1 Intervention

Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Group IV: VC Period: Vehicle Cream BIDPlacebo Group1 Intervention

Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Group V: VC Extension Period/Escape Arm: Vehicle Cream BIDPlacebo Group1 Intervention

Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Cream

2018

Completed Phase 3

~740

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