Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
2 other identifiers
interventional
254
12 countries
84
Brief Summary
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Longer than P75 for phase_2
84 active sites
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
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedStudy Start
First participant enrolled
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedResults Posted
Study results publicly available
June 27, 2019
CompletedJune 27, 2019
May 1, 2019
2.1 years
September 27, 2012
April 8, 2019
May 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Remission at Week 8
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150 at week 8. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Week 8
Secondary Outcomes (7)
Percentage of Participants With Remission at Week 12
Week 12
Percentage of Participants With Response at Week 12
Baseline and week 12
Percentage of Participants With Response at Week 8
Baseline and week 8
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
Week 12 and week 24
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
Week 8 and week 24
- +2 more secondary outcomes
Study Arms (4)
Placebo Q4W/Abrilumab 210 mg Q3M
PLACEBO COMPARATORParticipants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
EXPERIMENTALParticipants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
EXPERIMENTALParticipants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
Abrilumab 210 mg/Abrilumab 210 mg Q3M
EXPERIMENTALParticipants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M)for 108 weeks.
Interventions
Administered by subcutaneous injection.
Placebo matching to abrilumab administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to baseline
- Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline
- Evidence of active inflammation within 12 weeks prior to baseline
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor (TNF) agents or to corticosteroids (non-US sites only).
- Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
- Subject has no known history of active tuberculosis and has a negative test for tuberculosis during screening
You may not qualify if:
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24 weeks from baseline
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
- Evidence of an infected abscess
- Bowel perforation or evidence of non-inflammatory obstruction during the 6 months prior to baseline
- Stool positive for C. difficile toxin at screening
- Any uncontrolled or clinically significant systemic disease
- Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV)
- Any underlying condition that predisposes subject to infections
- Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of baseline
- Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids within protocol-specified time periods.
- Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab, efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any form of cell-based transplantation
- Received treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (84)
Research Site
Birmingham, Alabama, 35216, United States
Research Site
Dothan, Alabama, 36305, United States
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Mobile, Alabama, 36608, United States
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Goodyear, Arizona, 85395, United States
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Phoenix, Arizona, 85012, United States
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La Jolla, California, 92093, United States
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Jacksonville, Florida, 32256, United States
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Sanford, Florida, 32771, United States
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Atlanta, Georgia, 30342, United States
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Arlington Heights, Illinois, 60005, United States
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Ann Arbor, Michigan, 48109, United States
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Chesterfield, Michigan, 48047, United States
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Rochester, Minnesota, 55905, United States
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Mexico, Missouri, 65265, United States
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Great Neck, New York, 11021, United States
Hospital
New York, New York, 10029, United States
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New York, New York, 10029, United States
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Charlotte, North Carolina, 28210, United States
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Greenville, North Carolina, 27834, United States
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Mentor, Ohio, 44060, United States
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Oklahoma City, Oklahoma, 73103, United States
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Philadelphia, Pennsylvania, 19104, United States
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Germantown, Tennessee, 38138, United States
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Seattle, Washington, 98101, United States
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Innsbruck, 6020, Austria
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Sankt Veit an der Glan, 9300, Austria
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Vienna, 1050, Austria
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Vienna, 1090, Austria
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Bonheiden, 2820, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Edmonton, Alberta, T6G 2X8, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Greater Sudbury, Ontario, P3E 1H5, Canada
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London, Ontario, N6A 5A5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Hradec Králové, 500 12, Czechia
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Prague, 140 21, Czechia
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Prague, 140 59, Czechia
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Prague, 150 06, Czechia
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Prague, 170 04, Czechia
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Ústí nad Labem, 401 13, Czechia
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Aalborg, 9000, Denmark
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Århus C, 8000, Denmark
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Herlev, 2730, Denmark
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Hvidovre, 2650, Denmark
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Køge, 4600, Denmark
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Odense C, 5000, Denmark
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Amiens, 80054, France
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Caen, 14033, France
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Clichy, 92110, France
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Lille, 59037, France
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Nice, 06202, France
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Paris, 75475, France
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Paris, 75571, France
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Pessac, 33604, France
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Vandœuvre-lès-Nancy, 54511, France
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Hamburg, 20148, Germany
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Leipzig, 04105, Germany
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Minden, 32423, Germany
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Stuttgart, 70376, Germany
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Békéscsaba, 5600, Hungary
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Budapest, 1088, Hungary
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Budapest, 1125, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3526, Hungary
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Szekszárd, 7100, Hungary
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Amsterdam, 1105 AZ, Netherlands
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Breda, 4818 CK, Netherlands
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Leiden, 2333 ZA, Netherlands
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Maastricht, 6229 HX, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Zurich, 8091, Switzerland
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Birmingham, B18 7QH, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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London, NW1 2BU, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
Related Publications (1)
Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.
PMID: 28238174BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 1, 2012
Study Start
December 4, 2012
Primary Completion
December 26, 2014
Study Completion
April 10, 2018
Last Updated
June 27, 2019
Results First Posted
June 27, 2019
Record last verified: 2019-05