Study Stopped
The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups
Brodalumab (AMG 827) 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 827 in Subjects With Moderate to Severe Crohn's Disease
2 other identifiers
interventional
130
8 countries
50
Brief Summary
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
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 2010
Shorter than P25 for phase_2
50 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
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedStudy Start
First participant enrolled
November 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2011
CompletedResults Posted
Study results publicly available
January 3, 2022
CompletedJanuary 3, 2022
November 1, 2021
11 months
June 24, 2010
December 1, 2021
December 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Clinical Remission at Week 6
Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 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). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Week 6
Secondary Outcomes (7)
Percentage of Participants Who Achieved a CDAI Response at Week 6
Week 6
Change From Baseline in CDAI at Week 6
Baseline and week 6
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From first dose of study drug up to week 12.
Maximum Observed Concentration (Cmax) of Brodalumab
After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
Time to Maximum Observed Concentration (Tmax) of Brodalumab
After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.
- +2 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received placebo intravenously at baseline and week 4.
Brodalumab 210 mg
EXPERIMENTALParticipants received 210 mg brodalumab intravenously at baseline and week 4.
Brodalumab 350 mg
EXPERIMENTALParticipants received 350 mg brodalumab intravenously at baseline and week 4.
Brodalumab 700 mg
EXPERIMENTALParticipants received 700 mg brodalumab intravenously at baseline and week 4.
Interventions
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Eligibility Criteria
You may qualify if:
- Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
- Moderately to severely active Crohn's disease, as defined by a CDAI score \>250 and \< 450 at baseline
- Evidence of active inflammation
You may not qualify if:
- Short bowel syndrome
- Stricture with obstructive symptoms within 3 months
- Bowel surgery within 3 months
- Ileostomy and/or colostomy
- Any gastric or intestinal pouch
- Ulcerative colitis
- Evidence of an infected abscess
- Bowel perforation or evidence of noninflammatory obstruction during the 6 months
- Stool positive for C. Difficile toxin at screening
- Presence of active infection requiring treatment
- Serious infection within 8 weeks
- Significant concurrent medical conditions
- Pregnant or breast feeding
- Significant Laboratory abnormalities
- Any anti-tumor necrosis factor (TNF) agent within 2 months
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (50)
Research Site
Birmingham, Alabama, United States
Research Site
Dothan, Alabama, United States
Research Site
Lowell, Arkansas, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Hammond, Louisiana, United States
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Chevy Chase, Maryland, United States
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Rochester, Minnesota, United States
Research Site
Mexico, Missouri, United States
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Egg Harbor, New Jersey, United States
Research Site
Great Neck, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Germantown, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
San Antonio, Texas, United States
Research Site
Logan, Utah, United States
Research Site
Ogden, Utah, United States
Research Site
Kurralta Park, South Australia, Australia
Research Site
Box Hill, Australia
Research Site
Fitzroy, Australia
Research Site
Fremantle, Australia
Research Site
Bonheiden, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Roeselare, Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
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Lille, France
Research Site
Nice, France
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Paris, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
Research Site
Amsterdam, Netherlands
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Maastricht, Netherlands
Research Site
Rotterdam, Netherlands
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Bydgoszcz, Poland
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Olsztyn, Poland
Research Site
Opole, Poland
Research Site
Sopot, Poland
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Pontevedra, Galicia, Spain
Research Site
Santiago de Compostela, Galicia, Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 25, 2010
Study Start
November 9, 2010
Primary Completion
October 15, 2011
Study Completion
October 15, 2011
Last Updated
January 3, 2022
Results First Posted
January 3, 2022
Record last verified: 2021-11