Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee

A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072591

Enrollment

108

Registered

2010-02-22

Start date

2010-02-28

Completion date

2010-09-30

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Pain

Keywords

anti-NGF, OA, pain

Brief summary

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.

Interventions

DRUGMEDI-578

intravenous infusion, once

DRUGPlacebo for MEDI-578

Intravenous infusion, once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with painful osteoarthritis of the knee. * The pain from the knee must exceed pain experienced from any other condition. * Patients must be willing and able to discontinue all current analgesic treatment.

Exclusion criteria

* Any other form of arthritis than osteoarthritis. * Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis. * Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Safety variables (adverse events, vital signs, ECG, safety lab)	Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.

Secondary

Measure	Time frame
To characterize the pharmacokinetics of MEDI-578 in plasma.	Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.
To assess the immunogenicity of MEDI-578	Blood samples taken fortnightly from Day 1 until week 12.
To evaluate the analgesic efficacy of MEDI-578 during the night and day.	Patients will record their pain intensity every morning and evening during the 13 weeks study period.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026