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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO3157ASH1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-005369-19 | EudraCT Number |
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The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
This is a two-part, randomized (participants are assigned to treatment by chance), double-blind (participants and investigators do not know what study agent is being administered), placebo-controlled study. A placebo appears identical to a study agent, has no active ingredients, and helps investigators evaluate the effect of a study agent. In Part 1, following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract infection, due to inoculation with HRV 16, will be assessed in healthy participants for safety reasons. In Part 2, following administration of CNTO 3157 or placebo and inoculation with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard assessments to evaluate asthma treatments. The study (Parts 1 and 2) will be completed when the last participant completes the last visit (Week 11) in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Healthy participants (CNTO 3157 + HRV-16) | Experimental |
| |
| Part 1: Healthy participants (placebo + HRV-16) | Placebo Comparator |
| |
| Part 2: Asthmatic patients (CNTO 3157 + HRV-16) | Experimental |
| |
| Part 2: Asthmatic patients (placebo + HRV-16) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 3157 (healthy participants) | Drug | CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16). |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2) | Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score | Cold symptoms is rated using a 5 point scale (0=none and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms. | Up to 10 days after inoculation with HRV-16 |
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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 |
|---|---|---|---|---|---|---|
| Antwerp | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28734844 | Derived | Silkoff PE, Flavin S, Gordon R, Loza MJ, Sterk PJ, Lutter R, Diamant Z, Turner RB, Lipworth BJ, Proud D, Singh D, Eich A, Backer V, Gern JE, Herzmann C, Halperin SA, Mensinga TT, Del Vecchio AM, Branigan P, San Mateo L, Baribaud F, Barnathan ES, Johnston SL. Toll-like receptor 3 blockade in rhinovirus-induced experimental asthma exacerbations: A randomized controlled study. J Allergy Clin Immunol. 2018 Apr;141(4):1220-1230. doi: 10.1016/j.jaci.2017.06.027. Epub 2017 Jul 20. |
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| Placebo (healthy participants) | Drug | Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16. |
|
| CNTO 3157 (asthmatic patients) | Drug | CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16. |
|
| Placebo (asthmatic patients) | Drug | Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16. |
|
| HRV-16 | Other | Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris. |
|
| AUC of change from baseline in Cold and Chest Symptom Scale |
Cold and chest symptoms are rated using a 5 point scale: 0 using a 5 point scale (0=none and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms. |
| Up to 10 days after inoculation with HRV-16 |
| AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO) | Up to 10 days after inoculation with HRV-16 |
| AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1 | Up to 10 days after inoculation with HRV-16 |
| AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR) | Up to 10 days after inoculation with HRV-16 |
| AUC of the change from baseline in prebronchodilator percent predicted FEV1 | Up to 10 days after inoculation with HRV-16 |
| AUC of the change from baseline in prebronchodilator forced vital capacity (FVC) | Up to 10 days after inoculation with HRV-16 |
| AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75) | Up to 10 days after inoculation with HRV-16 |
| AUC of the change from baseline in prebronchodilator FEV1/FVC | Up to 10 days after inoculation with HRV-16 |
| AUC of change from baseline in average total asthma symptom diary score | Up to 10 days after inoculation with HRV-16 |
| Change from baseline in Asthma Control Questionnaire (ACQ) | ACQ is an instrument designed to evaluate asthma control. Seven items are scored on a 7-point scale (0=good control, 6=poor control) with the mean score as an overall summary score. Questions 1-6 are completed by the patient; the last item is entered by site personnel and corresponds to the patient's percent predicted FEV1 categorized according to the 7-point scale. Higher scores reflect poorer control. | Up to 10 days after inoculation with HRV-16 |
| Change from baseline in Cold Symptom Assessment Score | Clinical symptoms to HRV-16 will be assessed by using the Cold Symptom Assessment Score, wherein participants will report the presence and severity of their cold symptoms in the context of the previous 24 hours via an interactive interview with the study staff. The symptoms consist of nasal congestion (stuffy nose), rhinorrhea (runny nose), sore throat, sneezing, cough, headache, malaise (feeling run down, tired) and chilliness. Severity is rated using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms. | Up to 11 weeks |
| Change from baseline in Cold and Chest Symptom Scale | The Cold and Chest Symptom Scale contains 15 items composing 2 domains, a total cold score and a total chest score. Together, these 2 domains comprise the chest symptom assessment score. Total Cold Score domain: sneezing, runny nose, blocked or stuff nose, sore throat or hoarse voice, headache or face pain, generally unwell, chills, fever or shivery and cough and Total Chest Score domain: cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness and nocturnal cough, wheeze and breathlessness. Severity is rated using a 5 point scale: 0 using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms. | Up to 11 weeks |
| Change from baseline in log-transformed FENO over time | Up to 11 weeks |
| Change from baseline over time in prebronchodilator and postbronchodilator FEV1 | Up to 11 weeks |
| Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1 | Up to 11 weeks |
| Change from baseline over time in prebronchodilator and postbronchodilator FVC | Up to 11 weeks |
| Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75 | Up to 11 weeks |
| Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC | Up to 11 weeks |
| Change from baseline in morning/evening PEFR over time | Up to 11 weeks |
| Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS) | Nose and eye symptoms are rated by the patient using a 5-point categorical response scale from 0 to 4, where 0 indicates absent/no symptom, and 4 indicates extremely severe symptoms, with a 24-hour recall period. | Up to Day 22 |
| Change from baseline in average total asthma symptom diary score | Up to 11 weeks |
| Change from baseline in average number of nocturnal awakenings | Up to 11 weeks |
| Change from baseline in average rescue medication use over time | Up to 11 weeks |
| Number of symptom-free days | Up to 10 days after inoculation with HRV-16 |
| The maximum decrease from baseline in the prebronchodilator FEV1 measurements | Up to 10 days after inoculation with HRV-16 |
| Time to the maximum decrease relative to baseline in prebronchodilator FEV1 | Up to 10 days after inoculation with HRV-16 |
| Calgary |
| Alberta |
| Canada |
| Halifax | Nova Scotia | Canada |
| Hellerup | Denmark |
| København NV | Denmark |
| Borstel | Germany |
| Frankfurt | Germany |
| Amsterdam-Zuidoost | Netherlands |
| Groningen | Netherlands |
| Belfast | United Kingdom |
| Dundee | United Kingdom |
| London | United Kingdom |
| Manchester | 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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