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

This study has been withdrawn prior to enrollment.
(Study was withdrawn due to 2 cases of agranulocytosis in a different clinical trial with this same drug.)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01493882
First received: December 15, 2011
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: JNJ-39758979 30 mg/d
Drug: JNJ-39758979 100 mg/d
Drug: JNJ-39758979 300 mg/d
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The absolute change from baseline in percent-predicted prebronchodilator forced expiratory volume (FEV1) at Week 16 in Part 1 and in Part 2. [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in postbronchodilator percent-predicted forced expiratory volume in 1 second (FEV1) at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493882

Sponsors and Collaborators
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.
  More Information

No publications provided

Responsible Party: DIRECTOR CLINICAL DEVELOPMENT, Janssen R&D US
ClinicalTrials.gov Identifier: NCT01493882     History of Changes
Other Study ID Numbers: CR100710, 39758979ASH2002, 2011-003852-37
Study First Received: December 15, 2011
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Uncontrolled Persistent Asthma, Dyspnea, Wheezing

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014