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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170337
• Other study ID #: 20110236
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2014
• Last updated: May 30, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Drug:
• AMG 282
AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps
• Placebo
Contains no active drug

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Research Site	Houston	Texas
United States	Research Site	Santa Monica	California
United States	Research Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)	169 days	Yes
Primary	Immunogenicity	Subject incidence of anti-AMG 282 antibodies	169 days	Yes
Secondary	Pharmacokinetic profile of AMG 282	Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval t [AUCt] after the first and last dose, and maximum observed concentration [Cmax]).	169 days	No

External Links

•   AmgenTrials clinical trials website