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

2014년 12월 11일 업데이트: Janssen Research & Development, LLC

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated With Human Rhinovirus Type 16

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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

76

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Amsterdam Zuidoost, 네덜란드
      • Groningen, 네덜란드
      • Hellerup, 덴마크
      • Kobenhavn Nv, 덴마크
      • Borstel, 독일
      • Frankfurt, 독일
      • Antwerp, 벨기에
      • Belfast, 영국
      • Dundee, 영국
      • London, 영국
      • Manchester, 영국
    • Alberta
      • Calgary, Alberta, 캐나다
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part 1: Healthy participants (CNTO 3157 + HRV-16)
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).
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
위약 비교기: Part 1: Healthy participants (placebo + HRV-16)
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.
실험적: Part 2: Asthmatic patients (CNTO 3157 + HRV-16)
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
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.
위약 비교기: Part 2: Asthmatic patients (placebo + HRV-16)
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)
기간: Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)

2차 결과 측정

결과 측정
측정값 설명
기간
Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score
기간: Up to 10 days after inoculation with HRV-16
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
AUC of change from baseline in Cold and Chest Symptom Scale
기간: Up to 10 days after inoculation with HRV-16
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)
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator percent predicted FEV1
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)
기간: Up to 10 days after inoculation with HRV-16
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)
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
AUC of the change from baseline in prebronchodilator FEV1/FVC
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
AUC of change from baseline in average total asthma symptom diary score
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
Change from baseline in Asthma Control Questionnaire (ACQ)
기간: Up to 10 days after inoculation with HRV-16
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
기간: Up to 11 weeks
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
기간: Up to 11 weeks

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
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV1
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FVC
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline in morning/evening PEFR over time
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)
기간: Up to Day 22
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
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline in average number of nocturnal awakenings
기간: Up to 11 weeks
Up to 11 weeks
Change from baseline in average rescue medication use over time
기간: Up to 11 weeks
Up to 11 weeks
Number of symptom-free days
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
The maximum decrease from baseline in the prebronchodilator FEV1 measurements
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16
Time to the maximum decrease relative to baseline in prebronchodilator FEV1
기간: Up to 10 days after inoculation with HRV-16
Up to 10 days after inoculation with HRV-16

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 10월 1일

기본 완료 (실제)

2014년 11월 1일

연구 완료 (실제)

2014년 11월 1일

연구 등록 날짜

최초 제출

2012년 10월 8일

QC 기준을 충족하는 최초 제출

2012년 10월 10일

처음 게시됨 (추정)

2012년 10월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 12월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 12월 11일

마지막으로 확인됨

2014년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CR100889
  • CNTO3157ASH1002 (기타 식별자: Janssen Research & Development, LLC)
  • 2011-005369-19 (EudraCT 번호)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

CNTO 3157 (healthy participants)에 대한 임상 시험

구독하다