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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 403
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with knee OA as determined by ACR criteria: Knee pain and radiographic osteophytes and at least 1 of the following 2 items: Morning stiffness 30 minutes, Crepitus on motion, a VAS pain score of ≥ 30 mm for index knee at screening,

Exclusion Criteria:

  • Weight of > 125 kg, Inflammatory arthropathy including secondary OA (eg, degenerative arthritis in patients with rheumatoid arthritis) as confirmed by a rheumatologist or investigator, Diagnosis of a condition other than knee OA that, in the investigator's opinion, may cause or affect pain or pain assessment in the index knee; these conditions may include but are not limited to radiculopathy or neuropathy, vasculopathy, fibromyalgia or active depression, Subjects taking neuromodulatory agents (antiepileptics or antidepressants) used as analgesic therapy for neuropathic pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AMG 403

    Placebo

    Arm Description

    AMG 403 administered as subcutaneous doses

    No active drug

    Outcomes

    Primary Outcome Measures

    Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
    Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs

    Secondary Outcome Measures

    Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
    serum concentrations and derived PK parameters of AMG 403

    Full Information

    First Posted
    December 2, 2014
    Last Updated
    December 12, 2014
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02318407
    Brief Title
    A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Younger and Older Subjects With Osteoarthritis Knee Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMG 403
    Arm Type
    Experimental
    Arm Description
    AMG 403 administered as subcutaneous doses
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    No active drug
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 403
    Intervention Description
    AMG 403 for the treatment of subjects with osteoarthritis
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    contains no active drug
    Primary Outcome Measure Information:
    Title
    Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
    Description
    Subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
    Time Frame
    from 197 days to 211 days
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
    Description
    serum concentrations and derived PK parameters of AMG 403
    Time Frame
    from 197 days to 211 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with knee OA as determined by ACR criteria: Knee pain and radiographic osteophytes and at least 1 of the following 2 items: Morning stiffness 30 minutes, Crepitus on motion, a VAS pain score of ≥ 30 mm for index knee at screening, Exclusion Criteria: Weight of > 125 kg, Inflammatory arthropathy including secondary OA (eg, degenerative arthritis in patients with rheumatoid arthritis) as confirmed by a rheumatologist or investigator, Diagnosis of a condition other than knee OA that, in the investigator's opinion, may cause or affect pain or pain assessment in the index knee; these conditions may include but are not limited to radiculopathy or neuropathy, vasculopathy, fibromyalgia or active depression, Subjects taking neuromodulatory agents (antiepileptics or antidepressants) used as analgesic therapy for neuropathic pain
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26449617
    Citation
    Gow JM, Tsuji WH, Williams GJ, Mytych D, Sciberras D, Searle SL, Mant T, Gibbs JP. Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects. Arthritis Res Ther. 2015 Oct 8;17:282. doi: 10.1186/s13075-015-0797-9.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain

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