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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02170337
First received: June 19, 2014
Last updated: May 30, 2016
Last verified: May 2016
  Purpose
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps

Condition Intervention Phase
Chronic Rhinosinusitis With Nasal Polyps Drug: AMG 282 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 169 days ]
    Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)

  • Immunogenicity [ Time Frame: 169 days ]
    Subject incidence of anti-AMG 282 antibodies


Secondary Outcome Measures:
  • Pharmacokinetic profile of AMG 282 [ Time Frame: 169 days ]
    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]).


Enrollment: 41
Study Start Date: July 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 282
AMG 282 administered as subcutaneous and intravenous doses.
Drug: AMG 282
AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps
Placebo Comparator: Placebo
No active drug
Drug: Placebo
Contains no active drug

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02170337

Locations
United States, California
Research Site
Santa Monica, California, United States, 90404
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Florida
Research Site
South Miami, Florida, United States, 33143
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02170337     History of Changes
Other Study ID Numbers: 20110236
Study First Received: June 19, 2014
Last Updated: May 30, 2016

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017