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

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01290042

Run by

Amgen

People needed

43

Starts

2011-02-01

Expected to finish

2014-05-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Bridgeport, Connecticut, United States
• Research Site — Danbury, Connecticut, United States
• Research Site — Miami, Florida, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Herston, Queensland, Australia
• Research Site — Adelaide, South Australia, Australia
• Research Site — Prahran, Victoria, Australia

Full record on ClinicalTrials.gov

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