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Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00771030
Collaborator
(none)
40
Enrollment
7
Arms
18.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This Phase 1b/2a study will evaluate safety, tolerability pharmacokinetics (PK) and pharmacodynamics (PD) of brodalumab when administered in multiple subcutaneous (SC) and intravenous (IV) doses in patients with active rheumatoid arthritis (RA) in combination with a stable dose of disease modulating anti-rheumatic drugs (DMARDs). Part A is dose escalation (to assess safety & tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of brodalumab from Part A.

Condition or Disease Intervention/Treatment Phase
  • Biological: Brodalumab
  • Other: Placebo
 Phase 1/Phase 2

Detailed Description

The dose-escalation phase consisted of 5 sequentially enrolled dose cohorts. Within each cohort participants were randomly assigned in a 3:1 ratio to receive brodalumab or placebo subcutaneously (cohorts 1 to 3) or intravenously (cohorts 5 and 6).

Dose escalations required acceptable safety data based on blinded review following completion of the day 15/week 3 visit by the final participant in each cohort and when six or more participants in a cohort had been administered at least three doses of brodalumab (cohorts 1, 2, 3 and 5). In cohort 6, dose escalation followed completion of the day 15/week 3 visit by the final patient in cohort 5 and six or more participants in cohort 5 had been administered two or more IV infusions of brodalumab.

Cohort 4 was designed to be used in the dose expansion phase to provide evidence of biological impact in 70 patients with RA receiving brodalumab at the dose determined during the dose escalation phase of the study. This cohort was not enrolled because a decision was made not to conduct Part B of the study; instead a separate phase 2 multiple-dose study was conducted to evaluate efficacy of brodalumab in patients with RA (Study 20090061; NCT00950989).

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis
Actual Study Start Date :
Oct 27, 2008
Actual Primary Completion Date :
May 25, 2010
Actual Study Completion Date :
May 25, 2010

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo SC (Cohorts 1-3)

Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.

Other: Placebo
Solution for subcutaneous or intravenous administration
Placebo Comparator: Placebo IV (Cohorts 5-6)

Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.

Other: Placebo
Solution for subcutaneous or intravenous administration
Experimental: Brodalumab 50 mg SC (Cohort 1)

Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.

Biological: Brodalumab
Solution for subcutaneous or intravenous administration
Other Names:
  • AMG 827

    		•
    Experimental: Brodalumab 140 mg SC (Cohort 2)

    Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.

    Biological: Brodalumab
    Solution for subcutaneous or intravenous administration
    Other Names:
  • AMG 827

    		•
    Experimental: Brodalumab 210 mg SC (Cohort 3)

    Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.

    Biological: Brodalumab
    Solution for subcutaneous or intravenous administration
    Other Names:
  • AMG 827

    		•
    Experimental: Brodalumab 420 mg IV (Cohort 5)

    Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.

    Biological: Brodalumab
    Solution for subcutaneous or intravenous administration
    Other Names:
  • AMG 827

    		•
    Experimental: Brodalumab 700 mg IV (Cohort 6)

    Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.

    Biological: Brodalumab
    Solution for subcutaneous or intravenous administration
    Other Names:
  • AMG 827

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment-emergent Adverse Events [From first dose of study drug up to end of study (week 19).]

      An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard.

    2. Number of Participants With Clinically Significant Changes in Safety Laboratory Tests [Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127.]

      The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported.

    3. Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings [From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6.]

    4. Number of Participants With Anti-brodalumab Antibodies [Days 1 (pre-dose), 29 (pre-dose), 85, and 127]

      Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab.

    Secondary Outcome Measures

    1. Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses [After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.]

    2. Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses [After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.]

    3. Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses [After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.]

    4. Accumulation Ratio for Brodalumab After Subcutaneous Dosing [After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.]

      Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).

    5. Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses [After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.]

    6. Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses [After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.]

    7. Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous Doses [After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.]

    8. Accumulation Ratio for Brodalumab After Intravenous Dosing [After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.]

      Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female between 18 to 70 years of age, inclusive at the time of screening

    • Diagnosed with RA as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria

    • Active RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) and at least 1 of the following:

    • Erythrocyte sedimentation rate (ESR) ≥ 28 mm, or

    • C-reactive protein (CRP) > 15 mg/L, or

    • Morning stiffness > 45 minutes (applicable to subjects in Part A ONLY)

    • Duration of RA for at least 6 months

    • Currently taking methotrexate (MTX) consecutively for ≥ 12 weeks and on a stable dose of oral or SC MTX at 15-25 mg weekly for ≥ 4 weeks at day -1. A lower MTX dose is acceptable if it is the highest tolerated dose, however, toxicity documentation by the Investigator is required. All subjects will take folic acid to minimize toxicity, according to local guidelines.

    • Additional Inclusion Criteria Apply

    Exclusion Criteria:

    • History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

    • Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, liver disease, asthma, cardiovascular disease or hypertension

    • Malignancy within 5 years (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin)

    • Presence of a serious or chronic infections

    • Subject (male or female) is not willing to use highly effective contraception, defined as a double barrier method (ie, spermicidal jelly and condom, or condom and diaphragm) during treatment and up to end of study

    • Additional Exclusion Criteria Apply

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT00771030
    Other Study ID Numbers:
    • 20070264
    First Posted:
    Oct 10, 2008
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Brodalumab

    Study Results

    Participant Flow

    Recruitment Details This study was conducted at 11 sites: 7 in the United States, 2 in Canada and 2 in Mexico.
    Pre-assignment Detail Within each cohort participants were randomized 3:1 to receive ascending doses of brodalumab or placebo subcutaneously (cohorts 1 to 3) or intravenously (cohorts 5 and 6). Cohort 4 was designed to be used in the dose expansion part of the study, however, this cohort was not enrolled because experimental endpoints would be achieved during a separate phase II study.
    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Period Title: Overall Study
    STARTED 6 4 6 6 6 6 6
    Received Study Drug 6 4 6 6 6 6 6
    COMPLETED 6 3 6 6 6 6 6
    NOT COMPLETED 0 1 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6) Total
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Total of all reporting groups
    Overall Participants 6 4 6 6 6 6 6 40
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.7
    (10.3)
    55.5
    (11.7)
    46.2
    (11.7)
    56.8
    (8.7)
    45.7
    (10.1)
    55.5
    (7.3)
    50.0
    (5.9)
    51.4
    (9.7)
    Sex: Female, Male (Count of Participants)
    Female
    5
    83.3%
    4
    100%
    6
    100%
    6
    100%
    5
    83.3%
    5
    83.3%
    3
    50%
    34
    85%
    Male
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    1
    16.7%
    3
    50%
    6
    15%
    Race/Ethnicity, Customized (Count of Participants)
    White
    4
    66.7%
    2
    50%
    3
    50%
    2
    33.3%
    1
    16.7%
    5
    83.3%
    1
    16.7%
    18
    45%
    Black or African American
    1
    16.7%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    5%
    Hispanic or Latino
    1
    16.7%
    1
    25%
    3
    50%
    4
    66.7%
    4
    66.7%
    1
    16.7%
    5
    83.3%
    19
    47.5%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    1
    2.5%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment-emergent Adverse Events
    Description An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard.
    Time Frame From first dose of study drug up to end of study (week 19).

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (placebo or brodalumab).
    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 4 6 6 6 6 6
    Any treatment-emergent adverse event (TEAE)
    3
    50%
    4
    100%
    5
    83.3%
    5
    83.3%
    4
    66.7%
    5
    83.3%
    4
    66.7%
    Serious TEAEs
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    Treatment-related TEAEs
    1
    16.7%
    2
    50%
    0
    0%
    3
    50%
    2
    33.3%
    2
    33.3%
    0
    0%
    Treatment-related serious TEAEs
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Discontinuation of study drug due to TEAE
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    Deaths on study
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Number of Participants With Clinically Significant Changes in Safety Laboratory Tests
    Description The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported.
    Time Frame Blood samples were taken on days 2, 8, 15, 29, 43, 57, 71, 85, 106, and 127.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 4 6 6 6 6 6
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Number of Participants With Clinically Significant Changes in Physical Examination Findings, Vital Signs, or Electrocardiogram Findings
    Description
    Time Frame From first dose of study drug up to 4 weeks after last dose; 14 weeks for Cohorts 1, 2, and 3 and 8 weeks for Cohorts 5 and 6.

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 4 6 6 6 6 6
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Number of Participants With Anti-brodalumab Antibodies
    Description Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab.
    Time Frame Days 1 (pre-dose), 29 (pre-dose), 85, and 127

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 4 6 6 6 6 6
    Binding antibodies
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    Neutralizing antibodies
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Time to Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses
    Description
    Time Frame After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received subcutaneously administered brodalumab with available data
    Arm/Group Title Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3)
    Arm/Group Description Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
    Measure Participants 6 6 6
    Day 1 (first dose)
    1.46
    3.96
    2.99
    Day 71 (last dose)
    2.00
    3.95
    4.00
    6. Secondary Outcome
    Title Maximum Concentration of Brodalumab After Single and Multiple Subcutaneous Doses
    Description
    Time Frame After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received subcutaneously administered brodalumab with available data
    Arm/Group Title Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3)
    Arm/Group Description Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
    Measure Participants 6 6 6
    Day 1 (first dose)
    0.742
    (0.522)
    5.67
    (2.98)
    16.6
    (8.97)
    Day 71 (last dose)
    1.35
    (1.07)
    5.93
    (5.15)
    18.4
    (7.21)
    7. Secondary Outcome
    Title Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Subcutaneous Doses
    Description
    Time Frame After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received subcutaneously administered brodalumab with available data
    Arm/Group Title Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3)
    Arm/Group Description Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
    Measure Participants 6 6 6
    Day 1 (first dose)
    1.77
    (1.61)
    37.6
    (27.8)
    142
    (67.3)
    Day 71 (last dose)
    4.13
    (3.20)
    50.8
    (51.5)
    191
    (82.7)
    8. Secondary Outcome
    Title Accumulation Ratio for Brodalumab After Subcutaneous Dosing
    Description Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).
    Time Frame After first dose on days 1 (pre-dose and 4 hours post-dose), 2, 3, 5, 8, 11, and 15 (pre-dose), and after last dose on days 71 (pre-dose and 4 hours post-dose), 72, 73, 75, 78, 81, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received subcutaneously administered brodalumab with available data
    Arm/Group Title Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3)
    Arm/Group Description Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
    Measure Participants 6 6 6
    Mean (Standard Deviation) [ratio]
    24.4
    (51.4)
    1.3
    (0.8)
    1.5
    (0.6)
    9. Secondary Outcome
    Title Time to Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses
    Description
    Time Frame After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received brodalumab by intravenous infusion with available data
    Arm/Group Title Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 6
    Day 1 (first dose)
    4.07
    0.92
    Day 29 (last dose)
    0.98
    0.83
    10. Secondary Outcome
    Title Maximum Concentration of Brodalumab After Single and Multiple Intravenous Doses
    Description
    Time Frame After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received brodalumab by intravenous infusion with available data
    Arm/Group Title Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 6
    Day 1 (first dose)
    111
    (19.2)
    240
    (44.8)
    Day 29 (last dose)
    127
    (12.1)
    655
    (949)
    11. Secondary Outcome
    Title Area Under the Concentration-time Curve From Time Zero to the Time of the Final Quantifiable Sample (AUC0-t) for Brodalumab After Single and Multiple Intravenous Doses
    Description
    Time Frame After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received brodalumab by intravenous infusion with available data
    Arm/Group Title Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 6
    Day 1 (first dose)
    831
    (197)
    1840
    (602)
    Day 29 (last dose)
    951
    (307)
    2230
    (998)
    12. Secondary Outcome
    Title Accumulation Ratio for Brodalumab After Intravenous Dosing
    Description Accumulation was measured by AUC0-t, last dose / AUC0-t, first dose).
    Time Frame After first dose on days 1 (pre-dose and 0.5 and 4 hours post-dose), 2, 3, 5, 8, 11, and 15, and after last dose on days 29 (pre-dose and 0.5 and 4 hours post-dose), 30, 31, 33, 36, 39, 43, 57, 85, 106 and 127.

    Outcome Measure Data

    Analysis Population Description
    Participants who received brodalumab by intravenous infusion with available data
    Arm/Group Title Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    Measure Participants 6 5
    Mean (Standard Deviation) [ratio]
    1.1
    (0.2)
    1.2
    (0.1)

    Adverse Events

    Time Frame From first dose of study drug up to end of study (week 19).
    Adverse Event Reporting Description
    Arm/Group Title Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Arm/Group Description Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
    All Cause Mortality
    Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Gastrointestinal disorders
    Gastrooesophageal reflux disease 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    General disorders
    Non-cardiac chest pain 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Nervous system disorders
    Complicated migraine 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo SC (Cohorts 1-3) Placebo IV (Cohorts 5-6) Brodalumab 50 mg SC (Cohort 1) Brodalumab 140 mg SC (Cohort 2) Brodalumab 210 mg SC (Cohort 3) Brodalumab 420 mg IV (Cohort 5) Brodalumab 700 mg IV (Cohort 6)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/6 (50%) 4/4 (100%) 5/6 (83.3%) 5/6 (83.3%) 4/6 (66.7%) 5/6 (83.3%) 4/6 (66.7%)
    Blood and lymphatic system disorders
    Anaemia 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%)
    Leukocytosis 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%)
    Cardiac disorders
    Palpitations 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Ear and labyrinth disorders
    Ear pain 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Eye disorders
    Conjunctivitis 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Dry eye 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Lacrimation increased 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Vision blurred 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Gastrointestinal disorders
    Abdominal discomfort 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Abdominal pain 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Abdominal pain upper 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Constipation 1/6 (16.7%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%)
    Diarrhoea 0/6 (0%) 0/4 (0%) 0/6 (0%) 2/6 (33.3%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%)
    Dry mouth 0/6 (0%) 0/4 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Dyspepsia 0/6 (0%) 1/4 (25%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Food poisoning 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Gastritis 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Nausea 1/6 (16.7%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Odynophagia 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Vomiting 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%)
    General disorders
    Administration site pain 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Chest discomfort 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Chills 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Fatigue 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Injection site erythema 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Injection site haematoma 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Non-cardiac chest pain 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Pyrexia 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Infections and infestations
    Amoebiasis 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Bronchitis 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Cellulitis 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Fungal skin infection 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Furuncle 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Gastroenteritis 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Herpes zoster 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Influenza 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Laryngitis 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Nasopharyngitis 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Oropharyngeal candidiasis 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Pharyngitis 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Upper respiratory tract infection 0/6 (0%) 1/4 (25%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Vulvovaginal mycotic infection 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Injury, poisoning and procedural complications
    Contusion 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Eschar 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Metabolism and nutrition disorders
    Hypokalaemia 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Back pain 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Muscle contracture 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Muscle spasms 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)
    Muscle twitching 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Rheumatoid arthritis 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Nervous system disorders
    Dizziness 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Dysgeusia 0/6 (0%) 1/4 (25%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Headache 2/6 (33.3%) 2/4 (50%) 1/6 (16.7%) 1/6 (16.7%) 2/6 (33.3%) 2/6 (33.3%) 2/6 (33.3%)
    Hypoaesthesia 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Paraesthesia 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Psychiatric disorders
    Abnormal dreams 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Affect lability 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Sleep disorder 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Reproductive system and breast disorders
    Breast cyst 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Menstrual disorder 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 2/6 (33.3%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%)
    Dyspnoea 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Nasal congestion 0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Oropharyngeal pain 1/6 (16.7%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Respiratory tract congestion 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Rhinorrhoea 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Sinus congestion 1/6 (16.7%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Sneezing 1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%)
    Skin and subcutaneous tissue disorders
    Alopecia 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Dermatitis 0/6 (0%) 0/4 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Dry skin 0/6 (0%) 1/4 (25%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Pruritus 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%)
    Rash 0/6 (0%) 1/4 (25%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%)
    Vascular disorders
    Hypertension 0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%)

    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:
    NCT00771030
    Other Study ID Numbers:
    • 20070264
    First Posted:
    Oct 10, 2008
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Oct 1, 2021