A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16

NCT ID: NCT01704040

Last Updated: 2014-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-11-30

Brief Summary

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).

Detailed Description

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.

Conditions

Healthy Volunteers and Asthma

Keywords

Healthy volunteers and asthma; CNTO 3157; Rhinovirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Healthy participants (CNTO 3157 + HRV-16)

Group Type: EXPERIMENTAL

CNTO 3157 (healthy participants)

Intervention Type: 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).

HRV-16

Intervention Type: OTHER

Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.

Part 1: Healthy participants (placebo + HRV-16)

Group Type: PLACEBO_COMPARATOR

Placebo (healthy participants)

Intervention Type: DRUG

Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.

HRV-16

Intervention Type: OTHER

Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.

Part 2: Asthmatic patients (CNTO 3157 + HRV-16)

Group Type: EXPERIMENTAL

CNTO 3157 (asthmatic patients)

Intervention Type: 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.

HRV-16

Intervention Type: OTHER

Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.

Part 2: Asthmatic patients (placebo + HRV-16)

Group Type: PLACEBO_COMPARATOR

Placebo (asthmatic patients)

Intervention Type: 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

Intervention Type: OTHER

Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.

Interventions

CNTO 3157 (healthy participants)

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).

Intervention Type: DRUG

Placebo (healthy participants)

Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.

Intervention Type: DRUG

CNTO 3157 (asthmatic patients)

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.

Intervention Type: DRUG

Placebo (asthmatic patients)

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.

Intervention Type: DRUG

HRV-16

Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Understanding of the study and a signed informed consent form before any study-related procedures
• Willing and able to adhere to the restrictions specified in the protocol
• Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN
• Part 1 (healthy participants):
• a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive
• b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2
• Part 2:
• a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2
• b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2
• c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2

Exclusion Criteria

• Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation
• At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual
• Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1
• Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study
• Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1
• Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator
• Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma
• Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1
• Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids
• Is receiving a high-dose inhaled corticosteroid (ICS) (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Antwerp, , Belgium

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

Countries

Belgium; Canada; Denmark; Germany; Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28734844 (View on PubMed)

Other Identifiers

CNTO3157ASH1002

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005369-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100889

Identifier Type: -

Identifier Source: org_study_id