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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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