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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT01094093
First received: March 25, 2010
Last updated: September 29, 2011
Last verified: September 2011
  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:


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
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: NCT01094093

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
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 July 31, 2014