Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis - Full Text View

Purpose

The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).

Condition	Intervention	Phase
Psoriasis	Drug: AMG 139	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139 [ Time Frame: 16-24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Characterization of the pharmacokinetics (PK) of AMG 139 [ Time Frame: 16-24 weeks ] [ Designated as safety issue: No ]
Psoriasis Activity and Severity Index (PASI) scores (Part B only) [ Time Frame: 16-24 weeks ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	April 2010
Study Completion Date:	September 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part B Four dose levels of AMG 139 administered as a single dose SC or IV in subjects with moderate-severe psoriasis (Part B).	Drug: AMG 139 Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).
Experimental: Part A Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers.	Drug: AMG 139 Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Part A - Healthy Volunteers:

Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
Body mass index (BMI) between 18 and 32 kg/m2
Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
Additional inclusion criteria apply

Part B - Psoriasis Subjects:

Male or female of non-reproductive potential subjects with PsO between 18 to 55 years-of-age
Body mass index (BMI) between 18 and 32 kg/m2
Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of moderate to severe plaque PsO
Diagnosis of plaque PsO for at least 6 months
Moderate to severe plaque PsO defined by:
A minimum PASI score of ≥ 10
Psoriasis involving ≥ 10% of the Body Surface Area (BSA)
Additional inclusion criteria apply

Exclusion Criteria:

Parts A - Healthy Volunteers:

History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
Recent or on-going infection(s)
Underlying condition(s) that predisposes the subject to infections
History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
Additional exclusion criteria apply

Part B - Psoriasis Subjects:

History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
Recent or on-going infection(s)
Underlying condition(s) that predisposes the subject to infections
Guttate, pustular, or other non-plaque forms of PsO
Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
Additional exclusion criteria apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094093

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT01094093 History of Changes
Other Study ID Numbers:	20080767
Study First Received:	March 25, 2010
Last Updated:	September 29, 2011
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Amgen:

Amgen
AMG 139

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013