- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170337
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
May 30, 2016 updated by: Amgen
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90404
- Research Site
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Colorado
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Aurora, Colorado, United States, 80045
- Research Site
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Florida
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South Miami, Florida, United States, 33143
- Research Site
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Texas
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Houston, Texas, United States, 77030
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Healthy Volunteers:
Inclusion Criteria:
- Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
Exclusion Criteria:
- subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):
Inclusion Criteria:
- diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
- bilateral nasal polyps of grade 3 or 4
Exclusion Criteria:
- Forced Expiratory Volume (FEV1) </= 70%
- Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for > 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
No active drug
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Contains no active drug
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Experimental: AMG 282
AMG 282 administered as subcutaneous and intravenous doses.
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AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: 169 days
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Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
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169 days
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Immunogenicity
Time Frame: 169 days
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Subject incidence of anti-AMG 282 antibodies
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169 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile of AMG 282
Time Frame: 169 days
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Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval τ [AUCτ] after the first and last dose, and maximum observed concentration [Cmax]).
|
169 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
June 19, 2014
First Submitted That Met QC Criteria
June 19, 2014
First Posted (Estimate)
June 23, 2014
Study Record Updates
Last Update Posted (Estimate)
June 1, 2016
Last Update Submitted That Met QC Criteria
May 30, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20110236
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Rhinosinusitis With Nasal Polyps
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Christiane HaaseActive, not recruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsDenmark
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Ohio State UniversityActive, not recruitingChronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsUnited States
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GB001, Inc, a wholly owned subsidiary of Gossamer...CompletedChronic Rhinosinusitis Without Nasal Polyps (CRSsNP) | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)United States, Czechia, Ukraine
-
St. Paul's Sinus CentreRecruitingAsthma | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsCanada
-
Johns Hopkins UniversityGlaxoSmithKlineRecruitingChronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
-
Medical University of ViennaRecruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Nasal Polyps | Chronic Rhinosinusitis With Nasal PolypsAustria
-
Novartis PharmaceuticalsRecruitingChronic Rhinosinusitis With Nasal PolypsKorea, Republic of
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University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...RecruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
-
Johns Hopkins UniversityGenentech, Inc.RecruitingNasal Polyps | Chronic Rhinosinusitis With Nasal PolypsUnited States
-
AstraZenecaAmgenActive, not recruitingChronic Rhinosinusitis With Nasal PolypsUnited States, Canada, Denmark, Spain, United Kingdom, Germany, Hungary, China, Japan, Poland
Clinical Trials on AMG 282
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AmgenCompleted
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University of LeicesterGenentech, Inc.; Biomedical Research Centre- Respiratory (Glenfield Hospital...Completed
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AmgenCompletedAdvanced Solid TumorsBelgium, Canada, Australia, United States, Spain, Poland, France, Germany, Japan, United Kingdom
-
AmgenTerminatedRelapsed/Refractory Acute Myeloid Leukemia (AML)United States, Korea, Republic of, Australia, Japan, Germany, Canada
-
AmgenTerminatedCutaneous Lupus | LupusUnited States, Australia, Canada
-
Southwest Oncology GroupNational Cancer Institute (NCI)RecruitingLung Adenocarcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage IV Lung Cancer AJCC v8 | Recurrent Lung Non-Squamous Non-Small Cell CarcinomaUnited States, Guam
-
AmgenCompletedGlioblastoma or Malignant GliomaUnited States, Australia, Netherlands, Germany, Spain, France
-
AmgenActive, not recruitingNon-squamous Non-small Cell Lung Cancer | Epithelial Ovarian Cancer | Claudin 6-positive Advanced/Metastatic Malignant Solid TumorsUnited States, Australia, Switzerland
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AmgenCompletedAdvanced Solid TumorsUnited States, Belgium, Spain, Australia
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Xencor, Inc.TerminatedRelapsed/ Refractory Multiple MyelomaUnited States, Australia