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Janus Kinase (JAK) Inhibitor

VC Period: Ruxolitinib 1.5% Cream BID for Atopic Dermatitis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).

Eligible Conditions

Atopic Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 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

Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8

Secondary study objectives

Dermatitis, Atopic

LTS Period: Change From Baseline in CDLQI Score

LTS Period: Change From Baseline in DLQI Score

+37 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.

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.

Trial Design

7Treatment 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 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 II: VC Period: Ruxolitinib 0.75% Cream BIDExperimental Treatment1 Intervention

Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film 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 III: LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BIDExperimental Treatment1 Intervention

Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Group IV: LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BIDExperimental Treatment1 Intervention

Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the Long-term Safety (LTS) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Group V: LTS Period: Ruxolitinib 1.5% CreamExperimental Treatment1 Intervention

Arm description: 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 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Group VI: LTS Period: Ruxolitinib 0.75% CreamExperimental Treatment1 Intervention

Arm description: Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Group VII: 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 Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

FDA approved

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