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Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01290042
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Drug: AMG 181 Other: Placebo for AMG 181 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.
Study Start Date : February 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Placebo arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Other: Placebo for AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Active Comparator: Active arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Drug: AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.




Primary Outcome Measures :
  1. To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. [ Time Frame: 40 Weeks ]

Secondary Outcome Measures :
  1. To measure the area under the plasma concentration curve versus time of drug AMG 181. [ Time Frame: 29 Weeks ]
  2. To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181. [ Time Frame: 29 Weeks ]
  3. To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181. [ Time Frame: 29 weeks ]


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

Inclusion Criteria:

  • Body Mass Index (BMI) between 18 and 34 kg/m2
  • Normal physical and neurological examination, clinical laboratory values and ECG
  • Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
  • Crohn's Disease Activity Index (CDAI) score of >150 and < 450 at screening (for subjects with Crohn's disease)
  • Additional inclusion criteria apply

Exclusion Criteria:

  • 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 evaluations, procedures or completion
  • History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
  • Underlying condition(s) that predisposes the subject to infections
  • Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
  • Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
  • Subject has short bowel syndrome (for subjects with Crohn's disease)
  • Presence of an ostomy (for subjects with Crohn's disease)
  • Presence of a fistula (for subjects with Crohn's disease)
  • Additional exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290042


Locations
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United States, California
Research Site
Glendale, California, United States, 91206
United States, Connecticut
Research Site
Bridgeport, Connecticut, United States, 06606
Research Site
Danbury, Connecticut, United States, 06810
United States, Florida
Research Site
Miami, Florida, United States, 33143
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Australia, Queensland
Research Site
Herston, Queensland, Australia, 4006
Australia, South Australia
Research Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Research Site
Prahran, Victoria, Australia, 3004
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01290042    
Other Study ID Numbers: 20101261
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs