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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2010-019544-39
Secondary ID [2] 0 0
20090072
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission at Week 6
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a CDAI Response at Week 6
Timepoint [1] 0 0
Week 6
Secondary outcome [2] 0 0
Change From Baseline in CDAI at Week 6
Timepoint [2] 0 0
Baseline and week 6
Secondary outcome [3] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
From first dose of study drug up to week 12.
Secondary outcome [4] 0 0
Maximum Observed Concentration (Cmax) of Brodalumab
Timepoint [4] 0 0
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 outcome [5] 0 0
Time to Maximum Observed Concentration (Tmax) of Brodalumab
Timepoint [5] 0 0
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 outcome [6] 0 0
Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab
Timepoint [6] 0 0
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 outcome [7] 0 0
Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab
Timepoint [7] 0 0
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.

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2011
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Research Site - Kurralta Park
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Fitzroy
Recruitment hospital [4] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
- Kurralta Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Belgium
State/province [14] 0 0
Bonheiden
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Belgium
State/province [17] 0 0
Roeselare
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
France
State/province [23] 0 0
Lille cedex
Country [24] 0 0
France
State/province [24] 0 0
Nice Cedex 3
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 10
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Toulouse Cedex 09
Country [28] 0 0
France
State/province [28] 0 0
Vandoeuvre les Nancy
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Netherlands
State/province [30] 0 0
Maastricht
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Poland
State/province [32] 0 0
Bydgoszcz
Country [33] 0 0
Poland
State/province [33] 0 0
Olsztyn
Country [34] 0 0
Poland
State/province [34] 0 0
Opole
Country [35] 0 0
Poland
State/province [35] 0 0
Sopot
Country [36] 0 0
Spain
State/province [36] 0 0
Galicia
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01150890
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01150890