A Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis - Tabular View

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A Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis

This study is ongoing, but not recruiting participants.
Information provided by Alza Corporation, DE, USA

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis

Official Title ^†

A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Exploratory Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis That is Moderate in Severity

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of oral administration of four dose regimens of JNJ-26113100 prepared in a capsule formulation administered for 6 weeks in the treatment of adult atopic dermatitis that is moderate in severity.

Detailed Description

A multi-center, exploratory study will be done to evaluate the safety and effectiveness of JNJ-26113100 in the treatment of adult atopic dermatitis, including its effect on biomarkers. Approximately 140 adults with atopic dermatitis will take part in the study. After screening, they will be randomly (patients are assigned different treatments based on chance) assigned to one of four treatment groups in a sequential fashion to receive JNJ-26113100 50 mg once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily or matching placebo. Study medication will be dispensed in a blinded fashion. The patient, the study doctor and the study sponsor will not know the treatment to which the patient has been assigned. The first dose will be administered in the clinic. Depending on the treatment group, patients will take medication either once or twice daily for six weeks. Study visits will be conducted at the end of Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. A study termination visit will be conducted at the end of Week 8. The patient's skin will be assessed at following visits: screening, randomization, week 1, week 2, week 3, week 4, week 5, week 6 and at study termination. Medical history, physical examination, blood pressure, heart rate, respiratory rate, temperature and electrocardiograms will be checked periodically during the study. Blood and urine samples will be collected for standard safety laboratory tests, to measure the level of drug and to learn about the effect of the drug on markers of inflammation. Two skin biopsies from atopic dermatitis lesions will be collected during the study to assess changes in the inflammatory disease state. Patients developing flares of their disease may be treated with triamcinolone acetonide 0.1% ointment twice daily for up to 7 days.

Patients will receive JNJ-26113100 50 mg once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily or matching placebo capsules for 6 weeks.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Evaluate safety and efficacy of oral doses of JNJ-26113100 for 6 weeks; assessing adverse events, vital signs, laboratory findings, physical exams, electrocardiograms and accepted atopic dermatitis clinical measures in adults with atopic dermatitis

Secondary Outcome Measure ^†

Evaluate how the body processes JNJ-26113100 over time as well as the effects of JNJ-26113100 on inflammatory markers at following visits: randomization, week 1, week 3, week 6 and week 8.

Condition ^†

Atopic Dermatitis

Intervention ^†

Drug: JNJ-26113100

MEDLINE PMIDs

Links

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

140

Start Date ^†

March 2007

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Adults with atopic dermatitis involving >= 10% body surface area
In good general health (well-controlled asthma, allergic rhinitis and food allergies will be allowed)
Willing to use highly effective birth control methods throughout the study

Exclusion Criteria:

Use of specific systemic medications or phototherapy for atopic dermatitis within four weeks of dosing
Use of specific topical medications for atopic dermatitis within one week of dosing
Frequent acetaminophen or ibuprofen use
Active infection

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00455429

Organization ID

CR012946

Secondary IDs ^††

Study Sponsor ^†

Alza Corporation, DE, USA

Collaborators ^††

Investigators ^†

Study Director:

Alza Corporation Clinical Trial

Alza Corporation, DE, USA

Information Provided By

Alza Corporation, DE, USA

Verification Date

August 2008

First Received Date ^†

April 1, 2007

Last Updated Date

August 14, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.