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

Ulcerative Colitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290042
• Other study ID #: 20101261
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2011
• Last updated: March 12, 2015
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

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.

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.

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Herston	Queensland
Australia	Research Site	Prahran	Victoria
United States	Research Site	Bridgeport	Connecticut
United States	Research Site	Danbury	Connecticut
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Glendale	California
United States	Research Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		40 Weeks	Yes
Secondary	To measure the area under the plasma concentration curve versus time of drug AMG 181.		29 Weeks	No
Secondary	To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.		29 Weeks	Yes
Secondary	To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.		29 weeks	Yes

External Links

•   AmgenTrials clinical trials website