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Long-term Safety Study of Brodalumab in Adults With Crohn's Disease

Sponsor
Amgen (Industry)
Overall Status
Terminated
CT.gov ID
NCT01199302
Collaborator
(none)
67
Enrollment
34
Locations
1
Arm
8.5
Actual Duration (Months)
2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Brodalumab
 Phase 2

Detailed Description

This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease.

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease
Actual Study Start Date :
Feb 2, 2011
Actual Primary Completion Date :
Oct 18, 2011
Actual Study Completion Date :
Oct 18, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Biological: Brodalumab
Administered intravenously once every 4 weeks
Other Names:
  • AMG 827

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)]

      An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having 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. The investigator assessed whether each AE was possibly related to the study drug. A serious adverse event is defined as an AE that met at least 1 of the following serious 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.

    2. Percentage of Participants Who Achieved a CDAI Response [Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20]

      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.

    3. Percentage of Participants Who Achieved Clinical Remission [Weeks 2, 4, 6, 8, 10, 12, 16, and 20]

      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

    1. CDAI Score Over Time [Weeks 2, 4, 6, 8, 10, 12, 16, and 20]

      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.

    2. Change From Baseline in CDAI Score Over Time [Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20]

      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.

    3. Number of Participants Who Developed Anti-brodalumab Binding Antibodies [Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).]

      Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.

    4. Change From Baseline in C-reactive Protein (CRP) Levels Over Time [Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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

    • Subject received live vaccines within 12 weeks prior to the first dose of AMG 827 in
    • Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus within 4 weeks prior to the first dose of AMG 827 in

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States 35294
    2 Research Site Jacksonville Florida United States 32256
    3 Research Site Hammond Louisiana United States 70403
    4 Research Site Chevy Chase Maryland United States 20815
    5 Research Site Rochester Minnesota United States 55905
    6 Research Site Mexico Missouri United States 65265
    7 Research Site Great Neck New York United States 11021
    8 Research Site Charlotte North Carolina United States 28207
    9 Research Site Nashville Tennessee United States 37203
    10 Research Site San Antonio Texas United States 78229
    11 Research Site Ogden Utah United States 84405
    12 Research Site Kurralta Park South Australia Australia 5037
    13 Research Site Box Hill Victoria Australia 3128
    14 Research Site Fitzroy Victoria Australia 3065
    15 Research Site Fremantle Western Australia Australia 6160
    16 Research Site Bonheiden Belgium 2820
    17 Research Site Gent Belgium 9000
    18 Research Site Leuven Belgium 3000
    19 Research Site Roeselare Belgium 8800
    20 Research Site Vancouver British Columbia Canada V6Z 2K5
    21 Research Site Winnipeg Manitoba Canada R3A 1R9
    22 Research Site Hamilton Ontario Canada L8S 4J9
    23 Research Site Montreal Quebec Canada H3A 1A1
    24 Research Site Lille cedex France 59037
    25 Research Site Nice Cedex 3 France 06202
    26 Research Site Paris Cedex 10 France 75010
    27 Research Site Paris France 75571
    28 Research Site Toulouse Cedex 09 France 31059
    29 Research Site Vandoeuvre les Nancy France 54511
    30 Research Site Amsterdam Netherlands 1081 HV
    31 Research Site Bydgoszcz Poland 85-021
    32 Research Site Sopot Poland 81-757
    33 Research Site Barcelona Cataluña Spain 08036
    34 Research Site Pontevedra Galicia Spain 36164

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01199302
    Other Study ID Numbers:
    • 20100008
    • 2010-020881-53
    First Posted:
    Sep 10, 2010
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Amgen
    Amgen
    Crohn's
    Inflammatory Bowel Disease
    IBD
    Irritable Bowel Syndrome
    IBS
    Inflammation
    bowel
    colon
    gastrointestinal
    Additional relevant MeSH terms:
    Crohn Disease
    Brodalumab

    Study Results

    Participant Flow

    Recruitment Details This study enrolled participants who had completed the week 12 visit of the parent study 20090072 (NCT01150890). The study was conducted at 28 centers in Australia, Belgium, Canada, Spain, France, Netherlands, Poland, and the United States (US).
    Pre-assignment Detail In this long-term open-label extension study participants were to receive brodalumab 350 mg every 4 weeks. Results are reported by treatment group assigned in the parent study.
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Period Title: Overall Study
    STARTED 20 16 20 11
    COMPLETED 0 0 0 0
    NOT COMPLETED 20 16 20 11

    Baseline Characteristics

    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg Total
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Total of all reporting groups
    Overall Participants 20 16 20 11 67
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    35.2
    (12.0)
    36.3
    (10.0)
    35.4
    (13.4)
    37.6
    (13.2)
    35.9
    (12.0)
    Sex: Female, Male (Count of Participants)
    Female
    9
    45%
    10
    62.5%
    12
    60%
    7
    63.6%
    38
    56.7%
    Male
    11
    55%
    6
    37.5%
    8
    40%
    4
    36.4%
    29
    43.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    1
    5%
    0
    0%
    1
    1.5%
    Not Hispanic or Latino
    18
    90%
    12
    75%
    14
    70%
    10
    90.9%
    54
    80.6%
    Unknown or Not Reported
    2
    10%
    4
    25%
    5
    25%
    1
    9.1%
    12
    17.9%
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    0
    0%
    1
    6.3%
    0
    0%
    0
    0%
    1
    1.5%
    White
    17
    85%
    11
    68.8%
    14
    70%
    9
    81.8%
    51
    76.1%
    Other
    1
    5%
    0
    0%
    1
    5%
    1
    9.1%
    3
    4.5%
    Unknown
    2
    10%
    4
    25%
    5
    25%
    1
    9.1%
    12
    17.9%
    Crohn's Disease Activity Index (CDAI) at Baseline of Parent Study (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    317.24
    (65.21)
    321.13
    (54.01)
    336.90
    (58.92)
    298.37
    (43.75)
    320.94
    (57.87)
    Crohn's Disease Activity Index (CDAI) at Baseline of Extension Study (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    257.70
    (126.60)
    251.72
    (85.23)
    233.50
    (110.74)
    226.76
    (65.49)
    243.67
    (102.89)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
    Description An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having 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. The investigator assessed whether each AE was possibly related to the study drug. A serious adverse event is defined as an AE that met at least 1 of the following serious 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.
    Time Frame From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who received at least one dose of brodalumab in the extension study
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    All treatment-emergent adverse events (TEAEs)
    14
    70%
    12
    75%
    18
    90%
    8
    72.7%
    Serious adverse events
    4
    20%
    4
    25%
    5
    25%
    2
    18.2%
    Fatal adverse events
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TEAEs leading to discontinuation of study drug
    4
    20%
    1
    6.3%
    3
    15%
    1
    9.1%
    TEAEs leading to discontinuation from study
    3
    15%
    2
    12.5%
    3
    15%
    1
    9.1%
    Treatment-related treatment-emergent adverse events
    8
    40%
    9
    56.3%
    14
    70%
    2
    18.2%
    Treatment-related serious adverse events
    2
    10%
    2
    12.5%
    1
    5%
    1
    9.1%
    Treatment-related fatal adverse events
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Treatment-related TEAEs leading to discontinuation of study drug
    2
    10%
    1
    6.3%
    1
    5%
    0
    0%
    Treatment related TEAEs leading to discontinuation from study
    1
    5%
    1
    6.3%
    1
    5%
    0
    0%
    2. Primary Outcome
    Title Percentage of Participants Who Achieved a CDAI Response
    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 Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20

    Outcome Measure Data

    Analysis Population Description
    Participants in the full analysis set with available data at each time point.
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    Week 2
    23.5
    117.5%
    21.4
    133.8%
    50.0
    250%
    54.5
    495.5%
    Week 4
    23.1
    115.5%
    36.4
    227.5%
    47.4
    237%
    55.6
    505.5%
    Week 6
    38.5
    192.5%
    33.3
    208.1%
    53.3
    266.5%
    42.9
    390%
    Week 8
    40.0
    200%
    42.9
    268.1%
    40.0
    200%
    83.3
    757.3%
    Week 10
    62.5
    312.5%
    20.0
    125%
    27.3
    136.5%
    100.0
    909.1%
    Week 12
    83.3
    416.5%
    25.0
    156.3%
    62.5
    312.5%
    80.0
    727.3%
    Week 16
    100.0
    500%
    33.3
    208.1%
    100.0
    500%
    Week 20
    100.0
    500%
    0.0
    0%
    100.0
    500%
    50.0
    454.5%
    3. Primary Outcome
    Title Percentage of Participants Who Achieved Clinical Remission
    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 Weeks 2, 4, 6, 8, 10, 12, 16, and 20

    Outcome Measure Data

    Analysis Population Description
    Participants in the full analysis set with available data at each time point.
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    Week 2
    5.9
    29.5%
    7.1
    44.4%
    27.8
    139%
    27.3
    248.2%
    Week 4
    15.4
    77%
    9.1
    56.9%
    26.3
    131.5%
    22.2
    201.8%
    Week 6
    23.1
    115.5%
    0.0
    0%
    33.3
    166.5%
    28.6
    260%
    Week 8
    40.0
    200%
    0.0
    0%
    13.3
    66.5%
    50.0
    454.5%
    Week 10
    37.5
    187.5%
    0.0
    0%
    18.2
    91%
    75.0
    681.8%
    Week 12
    50.0
    250%
    0.0
    0%
    50.0
    250%
    60.0
    545.5%
    Week 16
    75.0
    375%
    33.3
    208.1%
    0.0
    0%
    Week 20
    100.0
    500%
    0.0
    0%
    100.0
    500%
    0.0
    0%
    4. Secondary Outcome
    Title CDAI Score Over Time
    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.
    Time Frame Weeks 2, 4, 6, 8, 10, 12, 16, and 20

    Outcome Measure Data

    Analysis Population Description
    Participants in the full analysis set with available data at each time point.
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    Week 2
    291.71
    (159.01)
    285.41
    (86.69)
    235.12
    (100.66)
    197.71
    (81.22)
    Week 4
    274.21
    (154.79)
    244.11
    (62.60)
    256.22
    (125.24)
    192.04
    (54.62)
    Week 6
    257.09
    (154.96)
    274.48
    (93.41)
    241.13
    (134.06)
    219.91
    (121.19)
    Week 8
    250.95
    (167.25)
    248.03
    (70.86)
    267.51
    (173.20)
    159.39
    (66.53)
    Week 10
    196.56
    (157.07)
    274.81
    (90.70)
    276.37
    (138.48)
    127.57
    (46.38)
    Week 12
    120.47
    (93.27)
    317.49
    (27.14)
    224.79
    (131.61)
    159.91
    (61.03)
    Week 16
    103.61
    (48.60)
    220.67
    (178.45)
    186.11
    (10.05)
    Week 20
    101.60
    (62.32)
    212.42
    145.33
    223.11
    (13.52)
    5. Secondary Outcome
    Title Change From Baseline in CDAI Score Over Time
    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.
    Time Frame Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20

    Outcome Measure Data

    Analysis Population Description
    Participants in the full analysis set with available data at each time point.
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    Week 2
    -25.8
    (128.0)
    -35.0
    (90.8)
    -97.0
    (106.9)
    -100.7
    (83.7)
    Week 4
    -49.7
    (112.5)
    -79.2
    (67.6)
    -78.2
    (107.3)
    -101.1
    (62.0)
    Week 6
    -55.4
    (101.4)
    -51.5
    (106.7)
    -84.3
    (128.3)
    -67.8
    (127.6)
    Week 8
    -48.7
    (143.2)
    -84.6
    (79.8)
    -55.4
    (157.2)
    -150.4
    (35.6)
    Week 10
    -116.1
    (103.5)
    -45.3
    (81.5)
    -56.1
    (146.5)
    -182.6
    (32.7)
    Week 12
    -174.5
    (76.0)
    -20.7
    (69.1)
    -80.8
    (120.4)
    -160.2
    (50.3)
    Week 16
    -162.1
    (51.3)
    -55.9
    (155.5)
    -128.8
    (33.6)
    Week 20
    -164.1
    (53.8)
    -61.3
    -109.7
    -91.8
    (57.2)
    6. Secondary Outcome
    Title Number of Participants Who Developed Anti-brodalumab Binding Antibodies
    Description Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.
    Time Frame Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).

    Outcome Measure Data

    Analysis Population Description
    Enrolled participants who received at least one dose of brodalumab in the extension study and with available antibody results
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Change From Baseline in C-reactive Protein (CRP) Levels Over Time
    Description
    Time Frame Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20

    Outcome Measure Data

    Analysis Population Description
    Participants in the full analysis set with available data at each time point.
    Arm/Group Title Placebo / Brodalumab 350 mg Brodalumab 210 mg / 350 mg Brodalumab 350 mg / 350 mg Brodaluamb 700 mg / 350 mg
    Arm/Group Description Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks. Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks. Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.
    Measure Participants 20 16 20 11
    Week 2
    13.0
    (33.9)
    10.7
    (53.8)
    -3.5
    (22.9)
    3.2
    (19.8)
    Week 4
    -0.8
    (9.9)
    -0.8
    (17.9)
    -8.1
    (25.9)
    9.9
    (52.4)
    Week 6
    5.2
    (14.1)
    5.9
    (26.2)
    -5.1
    (30.0)
    17.5
    (25.9)
    Week 8
    15.5
    (49.2)
    -2.4
    (15.0)
    3.7
    (19.9)
    7.2
    (49.5)
    Week 10
    11.5
    (31.9)
    4.3
    (28.8)
    0.9
    (34.1)
    -1.2
    (2.3)
    Week 12
    2.9
    (9.7)
    1.2
    (19.1)
    15.4
    (34.9)
    -11.5
    (17.9)
    Week 16
    1.0
    (18.1)
    0.2
    -9.5
    (11.5)
    -15.0
    (23.5)
    Week 20
    -3.0
    (3.4)
    -3.2
    -1.1
    -10.9
    (21.1)

    Adverse Events

    Time Frame From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
    Adverse Event Reporting Description
    Arm/Group Title Brodalumab 350 mg Q4W
    Arm/Group Description Participants received brodalumab 350 mg IV Q4W for up to 132 weeks.
    All Cause Mortality
    Brodalumab 350 mg Q4W
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Brodalumab 350 mg Q4W
    Affected / at Risk (%) # Events
    Total 15/67 (22.4%)
    Gastrointestinal disorders
    Abdominal pain 2/67 (3%)
    Anal stenosis 1/67 (1.5%)
    Crohn's disease 7/67 (10.4%)
    Intestinal dilatation 1/67 (1.5%)
    General disorders
    Pyrexia 3/67 (4.5%)
    Infections and infestations
    Gastroenteritis 1/67 (1.5%)
    Peritoneal abscess 1/67 (1.5%)
    Metabolism and nutrition disorders
    Dehydration 1/67 (1.5%)
    Skin and subcutaneous tissue disorders
    Cutaneous vasculitis 1/67 (1.5%)
    Other (Not Including Serious) Adverse Events
    Brodalumab 350 mg Q4W
    Affected / at Risk (%) # Events
    Total 36/67 (53.7%)
    Gastrointestinal disorders
    Abdominal pain 7/67 (10.4%)
    Abdominal tenderness 3/67 (4.5%)
    Constipation 3/67 (4.5%)
    Crohn's disease 9/67 (13.4%)
    Diarrhoea 4/67 (6%)
    Dyspepsia 3/67 (4.5%)
    Gastrooesophageal reflux disease 4/67 (6%)
    Nausea 3/67 (4.5%)
    General disorders
    Chills 3/67 (4.5%)
    Fatigue 5/67 (7.5%)
    Pyrexia 9/67 (13.4%)
    Infections and infestations
    Oral candidiasis 3/67 (4.5%)
    Upper respiratory tract infection 3/67 (4.5%)
    Urinary tract infection 3/67 (4.5%)
    Nervous system disorders
    Headache 5/67 (7.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

    Results Point of Contact

    Name/Title Study Director
    Organization Amgen Inc.
    Phone 866-572-6436
    Email medinfo@amgen.com
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01199302
    Other Study ID Numbers:
    • 20100008
    • 2010-020881-53
    First Posted:
    Sep 10, 2010
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Nov 1, 2021