An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; JNJ-26113100 (50 mg) once daily; JNJ-26113100 (100 mg) once daily; JNJ-26113100 (100 mg) twice daily; JNJ-26113100 (250 mg) twice daily
Intervention description: Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks.; JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.; JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.; JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.; JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; JNJ-26113100

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of four dose regimens
      (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis
      ([AD]; skin rash, inflammation) that is moderate in severity.
    

Eligibility criteria:

        Inclusion Criteria:-Adult participants with Atopic Dermatitis (skin rash, inflammation)
        involving greater than or equal to 10 percent body surface area

          -  Female participants must have a negative serum pregnancy test at screening

          -  With the exception of well-controlled asthma, allergic rhinitis and food allergies,
             participants must be in good general health prior to study participation with no
             clinically significant abnormalities as assessed by the investigator and determined by
             medical history, physical examination, blood chemistry, complete blood count,
             coagulation tests, urinalysis and electrocardiogram (ECG)

          -  Male subjects must consent to utilize a medically acceptable method of contraception
             throughout the study including the washout period and for three months after the study
             is completed

          -  Female participants of child bearing potential must consent to utilize a medically
             acceptable method of contraception throughout the study including the washout period
             and for three months after the study is completed Exclusion Criteria:-Evidence of
             clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic,
             pulmonary, neurologic, respiratory (with the exception of well-controlled asthma),
             endocrine or cardiovascular abnormalities or psychiatric disorders

          -  Participants with screening alanine aminotransferase, alkaline phosphatase or direct
             bilirubin levels above the upper limit of normal

          -  Evidence of any skin condition that in the opinion of the investigator would interfere
             with assessment of atopic dermatitis

          -  Use of any investigational drugs within the previous 30 days prior to dosing or within
             a period of less than five times the drug's half-life, whichever is longer

          -  Use of any biologic within a period of 5 times its half-life