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| ID | Type | Description | Link |
|---|---|---|---|
| 38518168ASH2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2012-004920-39 | EudraCT Number |
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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| JNJ-38518168 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablet, taken once daily |
| |
| JNJ-38518168 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1) | Expressed as percent of predicted value. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 16 |
| Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30102965 | Derived | 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. |
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| Drug |
JNJ-38518168, 30 mg tablet, taken once daily |
|
Expressed as percent of predicted value. |
| Baseline to Week 16 |
| 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. | Baseline to Week 16 |
| Change from baseline in weekly average of nighttime asthma diary symptom scores | 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 | Baseline to Week 16 |
| Los Angeles |
| California |
| United States |
| Mission Viejo | California | United States |
| San Diego | California | United States |
| Denver | Colorado | United States |
| Waterbury | Connecticut | United States |
| Minneapolis | Minnesota | United States |
| St Louis | Missouri | United States |
| Bellevue | Nebraska | United States |
| Lebanon | New Hampshire | United States |
| Rochester | New York | United States |
| Greenville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Medford | Oregon | United States |
| Portland | Oregon | United States |
| Altoona | Pennsylvania | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Calgary | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Hamilton | Ontario | Canada |
| Kingston | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| Montpellier | France |
| Berlin | Germany |
| Frankfurt | Germany |
| Großhansdorf | Germany |
| Hanover | Germany |
| Koblenz | Germany |
| Leipzig | Germany |
| Lübeck | Germany |
| Magdeburg | Germany |
| Mainz | Germany |
| Rüdersdorf | Germany |
| Ashkelon | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Ramat Gan | Israel |
| Rehovot | Israel |
| Tel Aviv | Israel |
| Chertsey | United Kingdom |
| Cottingham | United Kingdom |
| Dundee | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Portsmouth | United Kingdom |
| Southampton | United Kingdom |
| Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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