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AsthmaPhase 2NCT01823016

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

A Phase 2 study testing JNJ-38518168 in people with Asthma, run by Janssen Research & Development, LLC at 54 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
JNJ-38518168
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
54 sitesin 6 countries
Study dates
Sep 2013to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

54 sites in 6 countries.

54 sites in 6 countries

United States20 sites

  • Study site

    Altoona, Pennsylvania

  • Study site

    Bellevue, Nebraska

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Greenville, North Carolina

  • Study site

    Lebanon, New Hampshire

  • Study site

    Los Angeles, California

  • Study site

    Medford, Oregon

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mission Viejo, California

  • Study site

    Portland, Oregon

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Scottsdale, Arizona

  • Study site

    St Louis, Missouri

  • Study site

    Waterbury, Connecticut

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Germany10 sites

  • Study site

    Berlin

  • Study site

    Frankfurt

  • Study site

    Großhansdorf

  • Study site

    Hanover

  • Study site

    Koblenz

  • Study site

    Leipzig

  • Study site

    Lübeck

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Rüdersdorf

Other trials in Germany

Canada9 sites

  • Study site

    Calgary, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

United Kingdom8 sites

  • Study site

    Chertsey

  • Study site

    Cottingham

  • Study site

    Dundee

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Portsmouth

  • Study site

    Southampton

  • Study site

    Wolverhampton

Other trials in United Kingdom

Israel6 sites

  • Study site

    Ashkelon

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Ramat Gan

  • Study site

    Rehovot

  • Study site

    Tel Aviv

Other trials in Israel

France1 site

  • Study site

    Montpellier

Other trials in France

About this study

Official title: 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.

Read the 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..

Conditions
Asthma
Being tested
Placebo, JNJ-38518168
Keywords
Uncontrolled, persistent asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo tablet, taken once daily

  • JNJ-38518168Drug

    JNJ-38518168, 30 mg tablet, taken once daily

Study groups in NCT01823016
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
JNJ-38518168ExperimentalNot described
Receives: Drug: JNJ-38518168

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)

    Expressed as percent of predicted value.

    Measured: Baseline to Week 16

Secondary outcomes (5)

  1. Change from baseline in Asthma Control Questionnaire (ACQ)

    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.

    Measured: Baseline to Week 16

  2. Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)

    Expressed as percent of predicted value.

    Measured: Baseline to Week 16

  3. Change from baseline in weekly average of daytime asthma diary symptom scores

    Asthma diaries include questions about the frequency/severity of symptoms and impact on activities. Higher scores indicate more asthma symptoms.

    Measured: Baseline to Week 16

  4. Change from baseline in weekly average of nighttime asthma diary symptom scores

    Asthma diaries include questions about number of nocturnal awakenings.

    Measured: Baseline to Week 16

  5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used

    Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01823016
Sponsor's protocol ID
CR100976
Other IDs
38518168ASH2001, 2012-004920-39
Status last verified
Apr 2025
First submitted
28 Mar 2013
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30102965

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-38518168 in people with Asthma, run by Janssen Research & Development, LLC at 54 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Germany, Canada, United Kingdom, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1) (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01823016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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