Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
NCT ID: NCT01696396
Last Updated: 2019-06-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2012-12-04
2018-04-10
Brief Summary
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Detailed Description
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Participants who did not reach minimal improvement, or experienced disease worsening after initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M) beginning at double-blind period week 12 or after. Not reaching minimal improvement was defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2 consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week 8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI score of \> 150.
Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210 mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week 24), respectively. Due to a consistent discrepancy between the investigational product (IP) instruction manual (IPIM) description of vial positions and the actual vial positions in the IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with a randomization ratio of 3:2:1. The study was temporarily paused while this issue was investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and affected participants completed their double-blind treatment period, the study resumed enrollment and randomization per protocol. Neither the randomization nor study blind was compromised and therefore the intent-to-treat principle was maintained.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo Q4W/Abrilumab 210 mg Q3M
Participants 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
Administered by subcutaneous injection.
Placebo
Placebo matching to abrilumab administered by subcutaneous injection
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
Participants 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
Administered by subcutaneous injection.
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
Participants 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
Administered by subcutaneous injection.
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Participants 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.
Abrilumab
Administered by subcutaneous injection.
Placebo
Placebo matching to abrilumab administered by subcutaneous injection
Interventions
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Abrilumab
Administered by subcutaneous injection.
Placebo
Placebo matching to abrilumab administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Significant laboratory abnormalities
* Pregnant or breast feeding
18 Years
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Dothan, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Goodyear, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Sanford, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Arlington Heights, Illinois, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Chesterfield, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Mexico, Missouri, United States
Research Site
Great Neck, New York, United States
Hospital
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Site
Mentor, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Germantown, Tennessee, United States
Research Site
Seattle, Washington, United States
Research Site
Innsbruck, , Austria
Research Site
Sankt Veit an der Glan, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Bonheiden, , Belgium
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Hradec Králové, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Ústí nad Labem, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Århus C, , Denmark
Research Site
Herlev, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Køge, , Denmark
Research Site
Odense C, , Denmark
Research Site
Amiens, , France
Research Site
Caen, , France
Research Site
Clichy, , France
Research Site
Lille, , France
Research Site
Nice, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Pessac, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Hamburg, , Germany
Research Site
Leipzig, , Germany
Research Site
Minden, , Germany
Research Site
Stuttgart, , Germany
Research Site
Békéscsaba, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Szekszárd, , Hungary
Research Site
Amsterdam, , Netherlands
Research Site
Breda, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Maastricht, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Basel, , Switzerland
Research Site
Bern, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Birmingham, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Norwich, , United Kingdom
Research Site
Torquay, , United Kingdom
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-000529-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110232
Identifier Type: -
Identifier Source: org_study_id
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