A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults With Persistent Asthma

The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.

This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), parallel group (each group of participants will be treated at the same time), exploratory study (JNJ-39758979 is introduced in participants with asthma for the first time). This study consists of 4 phases: screening phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2 treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and treatment B (participants will receive placebo once daily). Safety will be evaluated by assessment of adverse events, clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram. Total study duration for each participant will be approximately 23 weeks.

Inclusion Criteria:

• Confirmed diagnosis of asthma for at least 6 months
• Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening
• Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening
• Having adequate laboratory values
• No history of/active or latent tuberculosis
• Agree to use protocol defined contraceptive methods

Exclusion Criteria:

• History of life-threatening asthma attack requiring hospitalization for asthma within 5 years of screening, or emergency department treatment of asthma within the last month
• Moderate or severe renal insufficiency
• Cigarette smoking within the last year - Viral or bacterial vaccination within the last month (eg, FluMist)
• Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive