NCT01290042

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2011

Typical duration for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

January 27, 2011

Last Update Submit

March 12, 2015

Conditions

Ulcerative ColitisCrohn's Disease

Outcome Measures

Primary Outcomes (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.

    40 Weeks

Secondary Outcomes (3)

  • To measure the area under the plasma concentration curve versus time of drug AMG 181.

    29 Weeks

  • To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.

    29 Weeks

  • To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.

    29 weeks

Study Arms (2)

Placebo arm

ACTIVE COMPARATOR

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

Active arm

ACTIVE COMPARATOR

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

Interventions

AMG 181DRUG

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 arm
Placebo for AMG 181OTHER

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.

Placebo arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Bridgeport, Connecticut, 06606, United States

Location

Research Site

Danbury, Connecticut, 06810, United States

Location

Research Site

Miami, Florida, 33143, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Herston, Queensland, 4006, Australia

Location

Research Site

Adelaide, South Australia, 5000, Australia

Location

Research Site

Prahran, Victoria, 3004, Australia

Location

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeCrohn Disease

Interventions

abrilumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 4, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

AU(3)US(5)