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Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

NCT03745638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2023-09-28

Study results available
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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).

Conditions

Interventions

DRUG

Ruxolitinib Cream

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

DRUG

Vehicle Cream

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Sponsors & Collaborators

Principal Investigators

  • Michael E. Kuligowski, MD, PhD, MBA · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2019-12-23
Completion
2020-12-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745638 on ClinicalTrials.gov