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

Johnson & Johnson (J&J)

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: JNJ-26113100 (100 mg) once daily; Drug: JNJ-26113100 (100 mg) twice daily; Drug: Placebo; Drug: JNJ-26113100 (50 mg) once daily; Drug: JNJ-26113100 (250 mg) twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00455429

C-2006-004

CR012946

Details and patient eligibility

About

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.

Full description

This study is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), sequential cohort exploratory study to evaluate the safety and effectiveness of JNJ-26113100 in the treatment of adult AD that is moderate in severity, including its effect on inflammatory biomarkers (biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease). Participants will be sequentially assigned to 50 milligram (mg) once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily cohort and randomly assigned to receive JNJ-26113100 or matching placebo.

The total duration of the study will be approximately 8 weeks. Participants will be asked to follow-up at the end of Week 1, 2, 3, 4, 5 and 6. A study termination visit (Day 57) will be conducted at the end of Week 8. Skin biopsies from atopic dermatitis lesions will be collected during the study to assess changes in the inflammatory disease state. Participants developing flares of their disease may be treated with triamcinolone acetonide 0.1 percent ointment twice daily for up to 7 days. Efficacy will be assessed using Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests, to measure the level of drug and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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84 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

JNJ-26113100 (50 mg) once daily

Experimental group

Treatment:

Drug: JNJ-26113100 (50 mg) once daily

JNJ-26113100 (100 mg) once daily

Experimental group

Treatment:

Drug: JNJ-26113100 (100 mg) once daily

JNJ-26113100 (100 mg) twice daily

Experimental group

Treatment:

Drug: JNJ-26113100 (100 mg) twice daily

JNJ-26113100 (250 mg) twice daily

Experimental group

Treatment:

Drug: JNJ-26113100 (250 mg) twice daily