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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/NCT01199302




Registration number
NCT01199302
Ethics application status
Date submitted
9/09/2010
Date registered
10/09/2010
Date last updated
28/12/2021

Titles & IDs
Public title
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
Scientific title
A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease
Secondary ID [1] 0 0
2010-020881-53
Secondary ID [2] 0 0
20100008
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
Other interventions - Brodalumab

Experimental: Brodalumab 350 mg - Participants received brodalumab 350 mg intravenously (IV) on day 1, week 4 and every 4 weeks thereafter for up to 132 weeks.


Other interventions: Brodalumab
Administered intravenously once every 4 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
Primary outcome [2] 0 0
Percentage of Participants Who Achieved a CDAI Response
Timepoint [2] 0 0
Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20
Primary outcome [3] 0 0
Percentage of Participants Who Achieved Clinical Remission
Timepoint [3] 0 0
Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Secondary outcome [1] 0 0
CDAI Score Over Time
Timepoint [1] 0 0
Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Secondary outcome [2] 0 0
Change From Baseline in CDAI Score Over Time
Timepoint [2] 0 0
Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Secondary outcome [3] 0 0
Number of Participants Who Developed Anti-brodalumab Binding Antibodies
Timepoint [3] 0 0
Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).
Secondary outcome [4] 0 0
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Timepoint [4] 0 0
Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20

Eligibility
Key inclusion criteria
- Subject was randomized into study 20090072 (NCT01150890) and completed the week 12
evaluation.

- Subject completed the week 12 evaluation in study 20090072 no more than 1 year prior
to the planned first visit of AMG 827 in 20100008.

- Subject or subject's legally acceptable representative has provided informed consent.

- Subject meets regional recommendations for immunizations, eg, United States Centers
for Disease Control and Prevention recommendations for subjects enrolled in the United
States.

- For subjects with = 3 months between the week 12 visit of 20090072 and the planned
first dose of AMG 827 in 20100008: If testing is clinically indicated in the opinion
of the investigator (eg, because of known recent exposure), then subject has negative
test for hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV).

- For female subjects with = 4 weeks between the week 12 visit of 20090072 and the
planned first dose of AMG 827 in 20100008: Subject has a negative urine pregnancy test
at baseline prior to the first dose of AMG 827 in the open-label extension (except
those at least 2 years post menopausal or surgically sterile).

- For female subjects with > 4 weeks between the week 12 visit of 20090072 and the
planned first dose of AMG 827 in 20100008: Subject has a negative serum pregnancy test
within 28 days before initiating AMG 827 and a negative urine pregnancy test at
baseline prior to the first dose of AMG 827 in the open-label extension (except those
at least 2 years post menopausal or surgically sterile).

- For subjects with = 3 months between the week 12 visit of 20090072 and the planned
first dose of AMG 827 in 20100008, if clinically indicated in the opinion of the
investigator (eg, because of known recent exposure) please assess the following:

- If the subject entered 20090072 with a negative purified protein derivative (PPD)
test: Subject must have a negative PPD test within 30 days prior to the planned first
dose of AMG 827. Tuberculin skin tests should be considered positive when they have
greater than or equal to 5 mm of induration at 48-72 hours after test is placed.

- If the subject entered 20090072 with a positive PPD: Subject must have a negative
Quantiferon test within 30 days prior to the planned first dose of AMG 827.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject had any serious adverse event reported during study 20090072 and considered to
be related to investigational product.

- Subject experienced an adverse event or laboratory abnormality in study 20090072 that,
in the opinion of the investigator, could cause extension of treatment to be
detrimental to the subject, prevent the subject from completing the study, or
interfere with the interpretation of the study results.

- Subject has known sensitivity to any of the products to be administered during dosing.

Other medical conditions

- Subject is currently experiencing an infection of Common Terminology Criteria for
Adverse Events grade 2 (if requiring oral medication) or higher. Subject is ineligible
until the infection resolves.

- Subject has a serious infection, defined as requiring hospitalization or intravenous
antibiotics, within 8 weeks before the first dose of AMG 827 in 20100008.

- For subjects with = 3 months between the week 12 visit of 20090072 and the planned
first dose of AMG 827 in 20100008: Subject has recurrent or chronic infections,
defined as = 3 infections requiring anti-microbials over the past 12 months prior to
screening.

- Subject has a significant concurrent medical condition, including

- Type 1 diabetes

- Uncontrolled type 2 diabetes

- Moderate to severe heart failure (New York Heart Association class III or IV)

- Myocardial infarction within the last year

- Current or history of unstable angina pectoris within the last year

- Uncontrolled hypertension as defined by resting blood pressure = 150/90 mmHg prior to
first investigational product dose (confirmed by a repeat assessment)

- Severe chronic pulmonary disease (eg, requiring oxygen therapy)

- Major chronic inflammatory disease or connective tissue disease other than Crohn's
disease (eg, systemic lupus erythematosus, rheumatoid arthritis, psoriasis)

- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or
melanoma

- History of cancer (except successfully treated in situ cervical cancer or squamous or
basal cell carcinoma of the skin).

- Any condition that, in the opinion of the investigator, might cause this study to be
detrimental to the subject

- Laboratory abnormalities

- For subjects with > 4 weeks between the week 12 visit of 20090072 and the planned
first dose of AMG 827 in 20100008, subject has laboratory abnormalities at screening,
including

- Elevated aspartate aminotransferase or alanine aminotransferase (> 2x upper limit of
normal)

- Serum direct bilirubin = 1.5x upper limit of normal

- Hemoglobin < 10 g/dL

- Hemoglobin A1c > 8.0 (for subjects with type 2 diabetes)

- Platelet count < 125,000 /mm^3

- White blood cell count < 3,000 cells/mm^3

- Absolute neutrophil count < 2,000/mm^3

- Creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab will calculate
value and provide to sites)

- Any other laboratory abnormality, which, in the opinion of the investigator, could
cause extension of treatment to be detrimental to the subject, prevent the subject
from completing the study, or interfere with the interpretation of the study results

- Washouts and non-permitted drugs

- Subject has used Tysabri (natalizumab) subsequent to study 20090072.

- Subject received an anti-tumor necrosis factor agent within 8 weeks prior to the first
dose of AMG 827 in 20100008.

- Subject received other commercially available biologic agent (eg, ustekinumab) within
12 weeks prior to the first dose of AMG 827 in 20100008.

- Subject received an investigational agent (other than AMG 827), investigational
procedure, or participated in an investigational device study subsequent to study
20090072.

- Subject received live vaccines within 12 weeks prior to the first dose of AMG 827 in
20100008.

- Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),
thalidomide, or tacrolimus within 4 weeks prior to the first dose of AMG 827 in
20100008.

- General or other

- Female subject is not willing to use highly effective contraception during treatment
with AMG 827 (except if at least 2 years postmenopausal or surgically sterile).

- Subject is pregnant or breast feeding, or planning to become pregnant while enrolled
in the study.

- Subject has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the subject to give written informed consent and/or to
comply with all required study procedures.

- Subject will not be available for protocol required study visits, to the best of the
subject and investigator's knowledge.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/10/2011
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
6160 - 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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Belgium
State/province [12] 0 0
Bonheiden
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Roeselare
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Lille cedex
Country [21] 0 0
France
State/province [21] 0 0
Nice Cedex 3
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 10
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Toulouse Cedex 09
Country [25] 0 0
France
State/province [25] 0 0
Vandoeuvre les Nancy
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Poland
State/province [27] 0 0
Bydgoszcz
Country [28] 0 0
Poland
State/province [28] 0 0
Sopot
Country [29] 0 0
Spain
State/province [29] 0 0
Cataluña
Country [30] 0 0
Spain
State/province [30] 0 0
Galicia

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with
brodalumab in adults with Crohn's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01199302
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/ct2/show/NCT01199302