A Study of MEDI7352 in Painful Osteoarthritis of the Knee

Chronic Pain Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508155
• Other study ID #: D5680C00001
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2015
• Est. completion date: December 23, 2020

Study information

• Verified date: April 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, drug levels and effects on the body of MEDI7352, in subjects with painful osteoarthritis of the knee.

Description:

An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female subjects with painful osteoarthritis (OA) of the knee. Female subjects must be postmenopausal or surgically sterile.

• Body weight between 50kg and 145kg

• Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

• Current treatment with another biologic therapeutic agent

• Current of historical diagnosis of RA

• Current diagnosis of an immunological condition that is associated with another form of arthritis in addition to OA, including traumatic arthritis or a seronegative spondyloarthropathy

• At risk of destructive arthropathy, including Rapidly Progressive Osteoarthritis (RPOA), osteonecrosis, spontaneous osteonecrosis of the knee, subchondral insufficiency fractures, hip dislocation and pathological fracture

• Presence of clinically significant neuropathy or other clinically significant disorder involving abnormal peripheral sensation.

• Current serious or unstable clinically important illness.

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• MEDI7352 for IV infusion
MEDI7352 for IV infusion
• Placebo for IV infusion
IV Placebo infusion
• MEDI7352 for Subcutaneous Injection
MEDI7352 for subcutaneous injection
• Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Sweden	Research Site	Go¨teborg
Sweden	Research Site	Stockholm
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	Adverse events, serious adverse events,	All visits from screening up to 56 days post single dose/84 days post multiple dose
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	Clinical laboratory assessments (serum chemistry, hematology, urinalysis)	All visits from screening up to 56 days post single dose/84 days post multiple dose
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	12 Lead electrocardiogram (including QTc, QRS, PR intervals and ventricular rate)	All visits from screening up to 56 days post single dose/84 days post multiple dose
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	Vital signs (systolic and diastolic BP), heart rate	All visits from screening up to 56 days post single dose/84 days post multiple dose
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352	MRI	At screening and at follow up visit.
Secondary	Area under the plasma drug concentration versus time curves for MEDI7352	Area under the plasma drug concentration versus time curves from zero to infinity and to last observation (AUC 0-inf; AUC 0-t).	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Maximum observed plasma drug concentration (Cmax) of MEDI7352	Maximum observed plasma drug concentration (Cmax).	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Time to maximum observed plasma drug concentration (Tmax) of MEDI7352	Time to maximum observed plasma drug concentration (Tmax).	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Terminal plasma elimination half-life (t1/2) of MEDI7352	Terminal plasma elimination half-life (t1/2).	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Apparent clearance (CL/F).	Apparent clearance (CL/F).	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	The presence of anti-drug antibodies (ADAs) to MEDI7352	The incidence of anti-drug antibodies (a measure of the body's immune response to the drug).	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Pain Numerical Rating Scale (NRS)	Numerical Rating Scale (NRS)	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.	All visits from screening up to 56 days post single dose/84 days post multiple dose
Secondary	Patients' Global Impression of Change Scale (PGIC)	Patients' Global Impression of Change Scale (PGIC)	All visits from screening up to 56 days post single dose/84 days post multiple dose