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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: AMG 403; Drug: Placebo

• Registration Number: NCT02318407
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Status Verified: 2014-12
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-12
• Last Update Submitted: 2014-12-12
• Study First Posted: 2014-12-17
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 403	AMG 403	AMG 403 administered as subcutaneous doses
Placebo	Placebo	No active drug

Primary Outcome Measures

Name	Time	Method
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	from 197 days to 211 days	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

Name	Time	Method
Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax	from 197 days to 211 days	serum concentrations and derived PK parameters of AMG 403