Clinical trial NCT01150890: Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Ileal Crohn's Disease
Ileo-colonic Crohn's Disease
Colonic Chron's Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Steroid enemas within 2 weeks
* Tysabri (natalizumab) within 1 year
* Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
* Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants Who Achieved a CDAI Response at Week 6
timeFrame: Week 6
measure: Change From Baseline in CDAI at Week 6
timeFrame: Baseline and week 6
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to week 12.
measure: Maximum Observed Concentration (Cmax) of Brodalumab
timeFrame: 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.
measure: Time to Maximum Observed Concentration (Tmax) of Brodalumab
timeFrame: 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.
measure: Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
timeFrame: 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.
measure: Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
timeFrame: 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, and 57.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Lowell
country: United States
facility: Research Site
state: Arkansas
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Hammond
country: United States
facility: Research Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Mexico
country: United States
facility: Research Site
state: Missouri
city: Egg Harbor Township
country: United States
facility: Research Site
state: New Jersey
city: Great Neck
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Logan
country: United States
facility: Research Site
state: Utah
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Kurralta Park
country: Australia
facility: Research Site
state: South Australia
city: Box Hill
country: Australia
facility: Research Site
city: Fitzroy
country: Australia
facility: Research Site
city: Fremantle
country: Australia
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Lille cedex
country: France
facility: Research Site
city: Nice Cedex 3
country: France
facility: Research Site
city: Paris Cedex 10
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Toulouse Cedex 09
country: France
facility: Research Site
city: Vandoeuvre les Nancy
country: France
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: