Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01258205
First received: December 9, 2010
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).


Condition Intervention Phase
Crohn's Disease
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 Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease

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: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: February 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part B
One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.
Drug: AMG 139
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
Experimental: Part A
Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.
Drug: AMG 139
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (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 Subjects:

  • 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 - Crohn's Subjects:

  • Male or female subjects with CD 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 mild to severe CD
  • Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
  • Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450
  • Elevated fecal calprotectin and CRP
  • Additional inclusion criteria apply

Exclusion Criteria:

Parts A - Healthy 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
  • History of malignancy of any type
  • Additional exclusion criteria apply

Part B only - Crohn's 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
  • History of malignancy of any type
  • 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: NCT01258205

Locations
United States, New Jersey
Research Site
Berlin, New Jersey, United States, 08009
United States, New York
Research Site
Stony Brook, New York, United States, 11794
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73102
United States, Virginia
Research Site
Richmond, Virginia, United States, 23291
Australia, Queensland
Research Site
Herston, Queensland, Australia, 4029
Australia, South Australia
Research Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Research Site
Prahran, Victoria, Australia, 3181
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01258205     History of Changes
Other Study ID Numbers: 20090519
Study First Received: December 9, 2010
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board
United States: Western Institutional Review Board
Australia: Human Research Ethics Committee
United States: Food and Drug Administration

Keywords provided by Amgen:
Amgen
AMG 139
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014