A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma
3 other identifiers
interventional
166
6 countries
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Sep 2013
Typical duration for phase_2 asthma
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 29, 2025
April 1, 2025
1.8 years
March 28, 2013
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)
Expressed as percent of predicted value.
Baseline to Week 16
Secondary Outcomes (5)
Change from baseline in Asthma Control Questionnaire (ACQ)
Baseline to Week 16
Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
Baseline to Week 16
Change from baseline in weekly average of daytime asthma diary symptom scores
Baseline to Week 16
Change from baseline in weekly average of nighttime asthma diary symptom scores
Baseline to Week 16
Change from baseline in weekly average of number of puffs in a day that rescue medication is used
Baseline to Week 16
Study Arms (2)
Placebo
PLACEBO COMPARATORJNJ-38518168
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Scottsdale, Arizona, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Lebanon, New Hampshire, United States
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Rochester, New York, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Montpellier, France
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Berlin, Germany
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Frankfurt, Germany
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Großhansdorf, Germany
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Hanover, Germany
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Koblenz, Germany
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Leipzig, Germany
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Lübeck, Germany
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Magdeburg, Germany
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Mainz, Germany
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Rüdersdorf, Germany
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Ashkelon, Israel
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Chertsey, United Kingdom
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Cottingham, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Portsmouth, United Kingdom
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Southampton, United Kingdom
Unknown Facility
Wolverhampton, United Kingdom
Related Publications (1)
Kollmeier AP, Barnathan ES, O'Brien C, Chen B, Xia YK, Zhou B, Loza MJ, Silkoff PE, Ge M, Thurmond RL. A phase 2a study of toreforant, a histamine H4 receptor antagonist, in eosinophilic asthma. Ann Allergy Asthma Immunol. 2018 Nov;121(5):568-574. doi: 10.1016/j.anai.2018.08.001. Epub 2018 Aug 11.
PMID: 30102965DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2013
First Posted
April 4, 2013
Study Start
September 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 29, 2025
Record last verified: 2025-04