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Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Brodalumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Ileal Crohn's Disease, Ileo-colonic Crohn's Disease, Colonic Chron's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Brodalumab 210 mg

Brodalumab 350 mg

Brodalumab 700 mg

Arm Description

Participants received placebo intravenously at baseline and week 4.

Participants received 210 mg brodalumab intravenously at baseline and week 4.

Participants received 350 mg brodalumab intravenously at baseline and week 4.

Participants received 700 mg brodalumab intravenously at baseline and week 4.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Achieved a CDAI Response at Week 6
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.
Change From Baseline in CDAI at Week 6
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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Maximum Observed Concentration (Cmax) of Brodalumab
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.
Time to Maximum Observed Concentration (Tmax) of Brodalumab
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.
Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
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.
Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
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.

Full Information

First Posted
June 24, 2010
Last Updated
December 1, 2021
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01150890
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups
Study Start Date
November 9, 2010 (Actual)
Primary Completion Date
October 15, 2011 (Actual)
Study Completion Date
October 15, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Ileal Crohn's Disease, Ileo-colonic Crohn's Disease, Colonic Chron's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo intravenously at baseline and week 4.
Arm Title
Brodalumab 210 mg
Arm Type
Experimental
Arm Description
Participants received 210 mg brodalumab intravenously at baseline and week 4.
Arm Title
Brodalumab 350 mg
Arm Type
Experimental
Arm Description
Participants received 350 mg brodalumab intravenously at baseline and week 4.
Arm Title
Brodalumab 700 mg
Arm Type
Experimental
Arm Description
Participants received 700 mg brodalumab intravenously at baseline and week 4.
Intervention Type
Biological
Intervention Name(s)
Brodalumab
Other Intervention Name(s)
AMG 827
Intervention Description
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as as an intravenous (IV) infusion over at least 30 minutes.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Clinical Remission at Week 6
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a CDAI Response at Week 6
Description
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.
Time Frame
Week 6
Title
Change From Baseline in CDAI at Week 6
Description
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.
Time Frame
Baseline and week 6
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
From first dose of study drug up to week 12.
Title
Maximum Observed Concentration (Cmax) of Brodalumab
Description
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.
Time Frame
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.
Title
Time to Maximum Observed Concentration (Tmax) of Brodalumab
Description
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.
Time Frame
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.
Title
Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
Description
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.
Time Frame
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.
Title
Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Dothan
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Lowell
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Hammond
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Mexico
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Egg Harbor Township
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Logan
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Ogden
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Kurralta Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Box Hill
Country
Australia
Facility Name
Research Site
City
Fitzroy
Country
Australia
Facility Name
Research Site
City
Fremantle
Country
Australia
Facility Name
Research Site
City
Bonheiden
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Roeselare
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Lille cedex
Country
France
Facility Name
Research Site
City
Nice Cedex 3
Country
France
Facility Name
Research Site
City
Paris Cedex 10
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Toulouse Cedex 09
Country
France
Facility Name
Research Site
City
Vandoeuvre les Nancy
Country
France
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Maastricht
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Olsztyn
Country
Poland
Facility Name
Research Site
City
Opole
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Pontevedra
State/Province
Galicia
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
State/Province
Galicia
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease

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