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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01150890
Registration number
NCT01150890
Ethics application status
Date submitted
24/06/2010
Date registered
25/06/2010
Date last updated
3/01/2022
Titles & IDs
Public title
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
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Scientific 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
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Secondary ID [1]
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2010-019544-39
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Secondary ID [2]
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20090072
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Brodalumab
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Participants received placebo intravenously at baseline and week 4.
Experimental: Brodalumab 210 mg - Participants received 210 mg brodalumab intravenously at baseline and week 4.
Experimental: Brodalumab 350 mg - Participants received 350 mg brodalumab intravenously at baseline and week 4.
Experimental: Brodalumab 700 mg - Participants received 700 mg brodalumab intravenously at baseline and week 4.
Other interventions: Brodalumab
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Treatment: Drugs: Placebo
Administered as as an intravenous (IV) infusion over at least 30 minutes.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved Clinical Remission at Week 6
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Assessment method [1]
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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.
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Timepoint [1]
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Week 6
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Secondary outcome [1]
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Percentage of Participants Who Achieved a CDAI Response at Week 6
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Assessment method [1]
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CDAI response is defined as a reduction from baseline in CDAI score of = 100 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.
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Timepoint [1]
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Week 6
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Secondary outcome [2]
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Change From Baseline in CDAI at Week 6
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Assessment method [2]
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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.
A negative change from baseline indicates improvement.
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Timepoint [2]
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Baseline and week 6
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Secondary outcome [3]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [3]
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An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug.
A serious AE is an adverse event that met at least one of the following criteria:
fatal,
life threatening,
required in-patient hospitalization or prolongation of existing hospitalization,
resulted in persistent or significant disability/incapacity,
congenital anomaly/birth defect, and/or
other significant medical hazard.
The investigator assessed whether each AE was possibly related to the study drug.
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Timepoint [3]
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From first dose of study drug up to week 12.
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Secondary outcome [4]
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Maximum Observed Concentration (Cmax) of Brodalumab
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Assessment method [4]
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An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 µg/mL.
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Timepoint [4]
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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.
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Secondary outcome [5]
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Time to Maximum Observed Concentration (Tmax) of Brodalumab
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Assessment method [5]
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An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 µg/mL.
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Timepoint [5]
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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.
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Secondary outcome [6]
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Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
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Assessment method [6]
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An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 µg/mL.
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Timepoint [6]
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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.
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Secondary outcome [7]
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Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
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Assessment method [7]
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An optional pharmacokinetic (PK) substudy was offered to participants at a subset of sites and required additional informed consent.
Serum concentrations of brodalumab were measured using a validated analytical method, enzyme-linked immusosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay was 0.0500 µg/mL.
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Timepoint [7]
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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.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/10/2011
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Sample size
Target
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Accrual to date
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Final
130
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Research Site - Kurralta Park
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Recruitment hospital [2]
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Research Site - Box Hill
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Recruitment hospital [3]
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Research Site - Fitzroy
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Recruitment hospital [4]
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Research Site - Fremantle
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Recruitment postcode(s) [1]
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- Kurralta Park
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Recruitment postcode(s) [2]
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- Box Hill
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Recruitment postcode(s) [3]
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- Fitzroy
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Recruitment postcode(s) [4]
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- Fremantle
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Arkansas
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United States of America
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Florida
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United States of America
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Louisiana
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Country [5]
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United States of America
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Maryland
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Minnesota
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United States of America
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Missouri
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New Jersey
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New York
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Country [10]
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United States of America
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North Carolina
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Tennessee
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Texas
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United States of America
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Utah
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Belgium
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Bonheiden
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Roeselare
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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France
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Lille cedex
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France
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Nice Cedex 3
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France
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Paris Cedex 10
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France
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Paris
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France
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Toulouse Cedex 09
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France
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Vandoeuvre les Nancy
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Netherlands
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Amsterdam
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Maastricht
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Netherlands
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Rotterdam
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Poland
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Bydgoszcz
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Poland
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State/province [33]
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Olsztyn
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Opole
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Poland
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Sopot
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Spain
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Galicia
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Spain
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Barcelona
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Spain
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01150890
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01150890
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