A Study of MEDI7352 in Painful Osteoarthritis of the Knee

April 14, 2021 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
  • United Kingdom
      • Belfast, United Kingdom, BT2 7BA
        • Research Site
      • London, United Kingdom, NW10 7EW
        • Research Site
      • Manchester, United Kingdom, M13 9NQ
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MEDI7352 IV
Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
Biological: MEDI7352 for IV infusion
MEDI7352 for IV infusion
Placebo Comparator: IV Placebo
Up to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
Biological: Placebo for IV infusion
IV Placebo infusion
Experimental: MEDI7352 Subcutaneous Injection
1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
Biological: MEDI7352 for Subcutaneous Injection
MEDI7352 for subcutaneous injection
Placebo Comparator: Subcutaneous Placebo
1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
Biological: Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Adverse events, serious adverse events,
All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Vital signs (systolic and diastolic BP), heart rate
All visits from screening up to 56 days post single dose/84 days post multiple dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
Time Frame: At screening and at follow up visit.
MRI
At screening and at follow up visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration versus time curves for MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
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
Maximum observed plasma drug concentration (Cmax) of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Maximum observed plasma drug concentration (Cmax).
All visits from screening up to 56 days post single dose/84 days post multiple dose
Time to maximum observed plasma drug concentration (Tmax) of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Time to maximum observed plasma drug concentration (Tmax).
All visits from screening up to 56 days post single dose/84 days post multiple dose
Terminal plasma elimination half-life (t1/2) of MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Terminal plasma elimination half-life (t1/2).
All visits from screening up to 56 days post single dose/84 days post multiple dose
Apparent clearance (CL/F).
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Apparent clearance (CL/F).
All visits from screening up to 56 days post single dose/84 days post multiple dose
The presence of anti-drug antibodies (ADAs) to MEDI7352
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
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
Pain Numerical Rating Scale (NRS)
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Numerical Rating Scale (NRS)
All visits from screening up to 56 days post single dose/84 days post multiple dose
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, stiffness subscale and function subscale.
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
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
Patients' Global Impression of Change Scale (PGIC)
Time Frame: All visits from screening up to 56 days post single dose/84 days post multiple dose
Patients' Global Impression of Change Scale (PGIC)
All visits from screening up to 56 days post single dose/84 days post multiple dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Bell, MB BCh BAO MRCGP FFPM, Biokinetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5680C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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