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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01150890
• Other study ID #: 20090072
• Secondary ID: 2010-019544-39
• Status: Terminated
• Phase: Phase 2
• Start date: November 9, 2010
• Est. completion date: October 15, 2011

Study information

• Verified date: November 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: October 15, 2011
• Est. primary completion date: October 15, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Brodalumab
Administered as as an intravenous (IV) infusion over at least 30 minutes.

Drug:
• Placebo
Administered as as an intravenous (IV) infusion over at least 30 minutes.

Locations

Country	Name	City	State
Australia	Research Site	Box Hill
Australia	Research Site	Fitzroy
Australia	Research Site	Fremantle
Australia	Research Site	Kurralta Park	South Australia
Belgium	Research Site	Bonheiden
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Roeselare
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Winnipeg	Manitoba
France	Research Site	Lille cedex
France	Research Site	Nice Cedex 3
France	Research Site	Paris
France	Research Site	Paris Cedex 10
France	Research Site	Toulouse Cedex 09
France	Research Site	Vandoeuvre les Nancy
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Rotterdam
Poland	Research Site	Bydgoszcz
Poland	Research Site	Olsztyn
Poland	Research Site	Opole
Poland	Research Site	Sopot
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Pontevedra	Galicia
Spain	Research Site	Santiago de Compostela	Galicia
United States	Research Site	Birmingham	Alabama
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chevy Chase	Maryland
United States	Research Site	Dothan	Alabama
United States	Research Site	Egg Harbor Township	New Jersey
United States	Research Site	Germantown	Tennessee
United States	Research Site	Great Neck	New York
United States	Research Site	Hammond	Louisiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Logan	Utah
United States	Research Site	Lowell	Arkansas
United States	Research Site	Mexico	Missouri
United States	Research Site	Miami	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	Ogden	Utah
United States	Research Site	Rochester	Minnesota
United States	Research Site	San Antonio	Texas
United States	Research Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 6
Secondary	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.	Baseline and week 6
Secondary	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.	From first dose of study drug up to week 12.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.	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.

External Links

•   AmgenTrials clinical trials website