NCT01497119

A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.

Detailed description

This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	JNJ-39758979, 300 mg	Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
DRUG	JNJ-39758979, 100 mg	Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
DRUG	Placebo	Form=tablet, route=oral use, once daily for 6 weeks.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-12-22
• Last updated: 2015-12-02

Locations

13 sites across 1 country: Japan