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

This study is currently recruiting participants.
Verified by Alza Corporation, DE, USA, August 2008

Sponsored by: Alza Corporation, DE, USA
Information provided by: Alza Corporation, DE, USA
ClinicalTrials.gov Identifier: NCT00455429
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: JNJ-26113100
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment:   140
Study Start Date:   March 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455429

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:     info1@veritasmedicine.com    

Show 24 study locations  Show 24 Study Locations

Sponsors and Collaborators
Alza Corporation, DE, USA

Investigators
Study Director:     Alza Corporation Clinical Trial     Alza Corporation, DE, USA    
  More Information

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

Study ID Numbers:   CR012946
First Received:   April 1, 2007
Last Updated:   August 29, 2008
ClinicalTrials.gov Identifier:   NCT00455429
Health Authority:   United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:
itch  
atopic  
eczema  
rash  

Study placed in the following topic categories:
Pruritus
Exanthema
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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