Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, 2-Part Study of JNJ-39758979 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma

The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or montelukast for at least 4 weeks.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: JNJ-39758979 30 mg/d; Drug: JNJ-39758979 100 mg/d; Drug: JNJ-39758979 300 mg/d

Detailed Description

This is a two-part study; each part of the study (Part 1 and Part 2) will be approximately 34 weeks in duration including a 4-week screening phase, a 24-week placebo-controlled treatment phase and a six-week follow-up phase. In Part 1, patients will be randomly assigned to receive placebo or JNJ-39758979 300 mg once daily through Week 24. In Part 2, patients will be randomly assigned to 1 of 4 treatment groups to receive treatment with placebo, 30 mg, 100 mg, or 300 mg of JNJ-39758979 once daily through Week 24. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of asthma will be performed both on a daily basis via electronic diary and at study visits.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Has a diagnosis of asthma for at least 6 months before screening. -Has been receiving inhaled corticosteroids (≤ 1000 µg fluticasone or its equivalent) alone or in conjunction with long-acting Beta 2-agonist (salmeterol, formoterol, etc.) and/or montelukast.
• Have an ACQ score ≥ 1.5 at screening. - Must be healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
• Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control.

Exclusion Criteria:

• Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit admission due to asthma. -Has a history of any other chronic respiratory condition including chronic obstructive pulmonary disease, bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea or pulmonary hypertension.-Has initiated or discontinued allergen immunotherapy within 12 weeks of screening. -Has smoked within 3 years of screening or has a history of smoking ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) or equivalent, or a positive urine cotinine test at Screening. -Has any known malignancy or has a history of malignancy with the exceptions of basal cell carcinoma or squamous cell carcinoma. -Has chronic or recurrent infectious disease, including, but not limited to: active tuberculosis.-Has a clinically significant, acute respiratory infection within 4 weeks of screening. -Has had a substance abuse (drug or alcohol) problem within the previous 3 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2
Experimental: JNJ-39758979 30 mg/d	Drug: JNJ-39758979 30 mg/d; Unit = mg, number = 30, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2
Experimental: JNJ-39758979 100 mg/d	Drug: JNJ-39758979 100 mg/d; Unit = mg, number = 100, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2
Experimental: JNJ-39758979 300 mg/d	Drug: JNJ-39758979 300 mg/d; Unit = mg, number = 300, form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The absolute change from baseline in percent-predicted prebronchodilator forced expiratory volume (FEV1) at Week 16 in Part 1 and in Part 2.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2	Baseline, Week 16
Change from baseline in postbronchodilator percent-predicted forced expiratory volume in 1 second (FEV1) at Week 16 in Part 1 and Part 2	Baseline, Week 16
Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2	Baseline, Week 16
Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2	Baseline, Week 16
Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Investigators: Study Director: Johnson & Johnson Pharmaceutical Research & Development Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 10, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Uncontrolled Persistent Asthma, Dyspnea, Wheezing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CR100710; 39758979ASH2002 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.); 2011-003852-37 (EudraCT Number)