Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis
A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis
2 other identifiers
interventional
359
19 countries
120
Brief Summary
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
Longer than P75 for phase_2
120 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 24, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Start
First participant enrolled
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2015
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
2.7 years
September 24, 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 total Mayo Score ≤ 2 points, with no individual subscore \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. 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 total Mayo Score (adjusted remission rate).
Week 8
Secondary Outcomes (3)
Percentage of Participants With Response at Week 8
Baseline and week 8
Percentage of Participants With Mucosal Healing at Week 8
Week 8
Percentage of Participants With Sustained Remission at Week 8 and Week 24
Week 8 and week 24
Study Arms (5)
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 7 mg Q4W/Abrilumab 210 mg Q3M
EXPERIMENTALParticipants received 7 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 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 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:
- Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report.
- Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score ≥2 prior to baseline
- Inadequate response to, loss of response to, or intolerance to at least one of the following treatments:
- Immunomodulators
- Anti-TNF agents
- 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
You may not qualify if:
- Disease limited to the rectum (ie, within 10 cm of the anal verge)
- Toxic megacolon
- Crohn's Disease
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
- Planned bowel surgery within 24 weeks from baseline
- Stool positive for C. Difficile toxin at screening
- History of gastrointestinal surgery within 8 weeks of baseline
- Primary Sclerosing Cholangitis
- Any uncontrolled or clinically significant systemic disease
- Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion.
- Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)
- Underlying condition that predisposes subject to infections (eg, uncontrolled diabetes; history of splenectomy)
- Known history of drug or alcohol abuse within 1 year of screening
- Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred \> 5 years ago, subject is eligible with documentation of disease free state since treatment)
- Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (123)
Research Site
Birmingham, Alabama, 35216, United States
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Dothan, Alabama, 36305, United States
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Mobile, Alabama, 36608, United States
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Scottsdale, Arizona, 85260, United States
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La Jolla, California, 92093, United States
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Torrance, California, 90505, United States
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Lone Tree, Colorado, 80124, United States
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Jacksonville, Florida, 32256, United States
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Miami, Florida, 33136, United States
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Naples, Florida, 34102, 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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Urbana, Illinois, 61801, United States
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Hammond, Louisiana, 70403, United States
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Chesterfield, Michigan, 48047, United States
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Rochester, Minnesota, 55905, United States
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Great Neck, New York, 11021, 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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Germantown, Tennessee, 38138, United States
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San Antonio, Texas, 78229, United States
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Seattle, Washington, 98101, United States
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Seattle, Washington, 98185, United States
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Bankstown, New South Wales, 2200, Australia
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Concord, New South Wales, 2139, Australia
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Adelaide, South Australia, 5000, Australia
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Box Hill, Victoria, 3128, Australia
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Innsbruck, 6020, Austria
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Sankt Veit an der Glan, 9300, Austria
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Vienna, 1090, Austria
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Bonheiden, 2820, Belgium
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Brussels, 1000, 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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Liège, 4000, Belgium
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Calgary, Alberta, T2N 4N1, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Kingston, Ontario, K7L 5G2, Canada
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London, Ontario, N6A 5A5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Hradec Králové, 500 12, Czechia
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Prague, 140 59, 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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Tallinn, 10117, Estonia
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Tallinn, 10138, Estonia
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Tartu, 51014, Estonia
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Amiens, 80054, France
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Caen, 14000, France
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Lille, 59037, France
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Nice, 06202, France
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Paris, 75571, France
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Pessac, 33604, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Berlin, 13353, Germany
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Berlin, 14050, Germany
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Frankfurt am Main, 60431, Germany
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Halle, 06120, Germany
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Heidelberg, 69120, Germany
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Kiel, 24105, Germany
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Athens, 10676, Greece
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Haidari, 12462, Greece
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Heraklion, 71110, Greece
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Larissa, 41110, Greece
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Piraeus, 18454, Greece
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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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Miskolc, 3529, Hungary
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Pécs, 7624, Hungary
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Szeged, 6725, Hungary
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Szekszárd, 7100, Hungary
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Milan, 20157, Italy
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Padua, 35128, Italy
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Roma, 00152, Italy
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Rozzano MI, 20089, Italy
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Riga, 1002, Latvia
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Riga, LV-1005, Latvia
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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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Oslo, 0450, Norway
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Tromsø, 9038, Norway
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Bialystok, 15-950, Poland
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Bydgoszcz, 85-079, Poland
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Lodz, 90-153, Poland
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Lodz, 90-242, Poland
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Lodz, 90-302, Poland
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Warsaw, 03-580, Poland
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Moscow, 123423, Russia
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Nizhny Novgorod, 603126, Russia
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Saint Petersburg, 191015, Russia
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Samara, 443063, Russia
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St.-Petrsburg, 196247, Russia
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Stavropol, 355017, Russia
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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, B15 2TH, United Kingdom
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Blackpool, FY3 8NR, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Derby, DE22 3NE, United Kingdom
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London, NW3 2QG, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Norwich, NR4 7UY, United Kingdom
Related Publications (1)
Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.
PMID: 30472236DERIVED
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 24, 2012
First Posted
September 27, 2012
Study Start
November 16, 2012
Primary Completion
July 13, 2015
Study Completion
April 10, 2018
Last Updated
June 27, 2019
Results First Posted
June 27, 2019
Record last verified: 2019-05