NCT03011892|CompletedPhase 2ResultsFDA Drug

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Incyte Corporation ClinicalTrials.gov

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1 other identifier

INCB 18424-206

Study Type

interventional

Target

307

Locations

2 countries

Sites

Timeline

RegisteredJan 2017

StartedJan 2017

CompletionMar 2018

Brief Summary

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

307

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach

2 countries

52 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

January 3, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed

4 days until next milestone

Study Start

First participant enrolled

January 9, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

April 9, 2021

Completed

Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

January 3, 2017

Results QC Date

January 25, 2021

Last Update Submit

March 16, 2021

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitiseczemapruritusJanus kinase (JAK) inhibitors

Outcome Measures

Primary Outcomes (1)

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Baseline and Week 4

Secondary Outcomes (9)

Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
Baseline, Week 2 and 8
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
Week 2, 4 and 8
Percentage Change From Baseline in EASI Score at Week 4
Baseline and Week 4
+4 more secondary outcomes

Study Arms (12)

Double Blind (DB): Vehicle BID

PLACEBO COMPARATOR

Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.

Drug: Vehicle Cream BID

DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID

ACTIVE COMPARATOR

Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.

Drug: Triamcinolone 0.1% Cream BIDDrug: Vehicle Cream BID

DB: Ruxolitinib 0.15% Once Daily (QD)

EXPERIMENTAL

Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.

Drug: Ruxolitinib 0.15% Cream QD

DB: Ruxolitinib 0.5% QD

EXPERIMENTAL

Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.

Drug: Ruxolitinib 0.5% Cream QD

DB: Ruxolitinib 1.5% QD

EXPERIMENTAL

Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.

Drug: Ruxolitinib 1.5% Cream QD