A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma

April 25, 2025 updated by: Janssen Research & Development, LLC

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be randomized (treatment group assigned by chance, like flipping a coin), double-blind (study investigators and participants will not know what treatment is being administered), and placebo-controlled (a placebo is identical to the study agent, but contains no active ingredients). A total of 160 participants will receive either placebo or JNJ-38518168 once daily. The study duration will be approximately 32 weeks and will include a screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a 4-week follow-up phase. Participant safety will be monitored throughout the entire study period..

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sainte Foy, Quebec, Canada
  • France
      • Montpellier, France
  • Germany
      • Berlin, Germany
      • Frankfurt, Germany
      • Großhansdorf, Germany
      • Hannover, Germany
      • Koblenz, Germany
      • Leipzig, Germany
      • Lübeck, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Rüdersdorf, Germany
  • Israel
      • Ashkelon, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Ramat Gan, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
  • United Kingdom
      • Chertsey, United Kingdom
      • Cottingham, United Kingdom
      • Dundee, United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
      • Portsmouth, United Kingdom
      • Southampton, United Kingdom
      • Wolverhampton, United Kingdom
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Los Angeles, California, United States
      • Mission Viejo, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Waterbury, Connecticut, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Bellevue, Nebraska, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1
  • Have been receiving inhaled corticosteroid (ICS) (≤1000 µg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1
  • At Screening Visit 1, be receiving the same dose of ICS ≤1000 µg/day fluticasone (or equivalent) alone or in conjunction with long-acting β2-agonist (LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening
  • Have an Asthma Control Questionnaire (ACQ) score ≥1.5 at Screening Visit 1
  • Have a prebronchodilator forced expiratory volume in 1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1
  • Have a ≥12% relative change and ≥200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2

Exclusion Criteria:

  • Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma
  • Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease
  • Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1; cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks of Screening Visit 1; theophylline within 4 weeks of Screening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1
  • Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1
  • Has smoked within 3 years of Screening Visit 1 or has a history of smoking ≥ 10 pack years
  • Body-Mass Index (BMI) greater than or equal to 40 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablet, taken once daily
Experimental: JNJ-38518168
Drug: JNJ-38518168
JNJ-38518168, 30 mg tablet, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)
Time Frame: Baseline to Week 16
Expressed as percent of predicted value.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Asthma Control Questionnaire (ACQ)
Time Frame: Baseline to Week 16
ACQ evaluates clinical impairment that participants with asthma may experience. Items are scored on a 7-point scale (0 = good control, 6 = poor control). Higher mean scores reflect poorer control.
Baseline to Week 16
Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
Time Frame: Baseline to Week 16
Expressed as percent of predicted value.
Baseline to Week 16
Change from baseline in weekly average of daytime asthma diary symptom scores
Time Frame: Baseline to Week 16
Asthma diaries include questions about the frequency/severity of symptoms and impact on activities. Higher scores indicate more asthma symptoms.
Baseline to Week 16
Change from baseline in weekly average of nighttime asthma diary symptom scores
Time Frame: Baseline to Week 16
Asthma diaries include questions about number of nocturnal awakenings.
Baseline to Week 16
Change from baseline in weekly average of number of puffs in a day that rescue medication is used
Time Frame: Baseline to Week 16
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimated)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100976
  • 38518168ASH2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2012-004920-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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