A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee

Study Purpose

This is a Phase 2b randomised, double-blind, placebo-controlled, dose-response study in subjects with painful osteoarthritis (OA) of the knee. The study will assess the safety and efficacy of multiple doses of MEDI7352 compared to placebo, as well as the pharmacokinetics, pharmacodynamics and immunogenicity of MEDI7352 in subjects with moderate to severe chronic pain persistent for 3 months or more not adequately controlled by standard of care treatments.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants must understand the nature of the study and must give signed and dated written informed consent prior to the initiation of any study procedures, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. For participants participating in the optional genetic research, a separate signed and dated optional genetic research ICF must be provided prior to collection of samples for optional genetic research that supports the Genomics Initiative. If a participant declines to participate in the genetic research, this will have no influence on the ability of a participant to participate in the study. 3. The participant should be willing and able to understand and comply with all protocol-specified restrictions and procedures and be able to use an electronic patient-reported outcome (ePRO) device as judged by the investigator. 4. The participant must be considered likely to comply with the study protocol and to have a high probability of completing the study, as judged by the investigator. 5. The participant must be willing and able to discontinue all analgesic therapy with NSAID or COX-2 inhibitors from the start of the washout period until the end of the FU period. This includes over-the-counter (OTC) pain medications and topical analgesics that contain an NSAID or COX-2 inhibitor. There are additional restrictions for medications use during the different periods of the clinical study.

Exclusion Criteria:

1. Requires current treatment with another biologic therapeutic agent, DMARD, or other immunosuppressants. 2. Previously received any form of anti-NGF, anti-TNF, or other biological DMARDs (including but not limited to golimumab, certolizumab, infliximab, adalimumab etanercept, rituximab, abatacept, tocilizumab, and tofacitinib) for 12 months prior to screening or received other immunosuppressants for 6 months prior to screening. 3. Currently receiving strong opioids for any indication. 4. Participation in another clinical study with an IP or device within 60 days or 5 half-lives, whichever is longer, prior to screening. 5. Plasma donation within 28 days of screening or any blood donation or blood loss > 50 mL within 2 months of screening. 6. Previous allogeneic bone marrow or stem cell transplant. 7. Received nonleukocyte-depleted whole blood transfusion within 120 days of the genetic research sample collection, if participating in the optional genetic research. 8. Involvement in the planning and/or conduct of the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04675034
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Denmark, Estonia, Germany, Poland, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Painful Osteoarthritis of the Knee
Arms & Interventions

Arms

Experimental: Cohort 1

Dose A: MEDI7352 Q2W

Experimental: Cohort 2

Dose B: MEDI7352 Q2W

Experimental: Cohort 3

Dose C: MEDI7352 Q2W

Experimental: Cohort 4

Dose D: MEDI7352 Q2W

Placebo Comparator: Cohort 5:

Placebo to match MEDI7352 Q2W

Interventions

Biological: - MEDI7352

Dose A: MEDI7352 Q2W

Biological: - MEDI7352

Dose B: MEDI7352 Q2W

Biological: - MEDI7352

Dose C: MEDI7352 Q2W

Biological: - MEDI7352

Dose D: MEDI7352 Q2W

Biological: - Placebo

Placebo to match MEDI7352 Q2W

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Montclair, California

Status

Not yet recruiting

Address

Research Site

Montclair, California, 91763

Research Site, Clearwater, Florida

Status

Not yet recruiting

Address

Research Site

Clearwater, Florida, 33756

Research Site, Coral Gables, Florida

Status

Not yet recruiting

Address

Research Site

Coral Gables, Florida, 33134

Research Site, Fort Myers, Florida

Status

Not yet recruiting

Address

Research Site

Fort Myers, Florida, 33912

Research Site, Jupiter, Florida

Status

Not yet recruiting

Address

Research Site

Jupiter, Florida, 33458

Research Site, Tampa, Florida

Status

Not yet recruiting

Address

Research Site

Tampa, Florida, 33606

Research Site, Valparaiso, Indiana

Status

Not yet recruiting

Address

Research Site

Valparaiso, Indiana, 46383

Research Site, Hazelwood, Missouri

Status

Not yet recruiting

Address

Research Site

Hazelwood, Missouri, 63042

Research Site, Lincoln, Nebraska

Status

Not yet recruiting

Address

Research Site

Lincoln, Nebraska, 68516

Research Site, Cincinnati, Ohio

Status

Not yet recruiting

Address

Research Site

Cincinnati, Ohio, 45242

Research Site, Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

Research Site

Oklahoma City, Oklahoma, 73103

Research Site, Duncansville, Pennsylvania

Status

Not yet recruiting

Address

Research Site

Duncansville, Pennsylvania, 16635

Research Site, Rapid City, South Dakota

Status

Not yet recruiting

Address

Research Site

Rapid City, South Dakota, 57702

Research Site, Dallas, Texas

Status

Not yet recruiting

Address

Research Site

Dallas, Texas, 75231

Research Site, Houston, Texas

Status

Not yet recruiting

Address

Research Site

Houston, Texas, 77034

Research Site, Houston, Texas

Status

Not yet recruiting

Address

Research Site

Houston, Texas, 77055

Research Site, Burke, Virginia

Status

Not yet recruiting

Address

Research Site

Burke, Virginia, 22015

Research Site, Bellevue, Washington

Status

Not yet recruiting

Address

Research Site

Bellevue, Washington, 98007

International Sites

Research Site, London, Ontario, Canada

Status

Not yet recruiting

Address

Research Site

London, Ontario, N6C 0A5

Research Site, Sherbrooke, Quebec, Canada

Status

Not yet recruiting

Address

Research Site

Sherbrooke, Quebec, J1L 0H8

Research Site, Trois-Rivieres, Quebec, Canada

Status

Not yet recruiting

Address

Research Site

Trois-Rivieres, Quebec, G8Z 1Y2

Research Site, Quebec, Canada

Status

Not yet recruiting

Address

Research Site

Quebec, , G1N 4V3

Research Site, Quebec, Canada

Status

Not yet recruiting

Address

Research Site

Quebec, , G1V 3M7

Research Site, Frederiksberg, Denmark

Status

Not yet recruiting

Address

Research Site

Frederiksberg, , 2000

Research Site, Tallinn, Estonia

Status

Recruiting

Address

Research Site

Tallinn, , 10117

Research Site, Tartu, Estonia

Status

Recruiting

Address

Research Site

Tartu, , 50708

Research Site, Freiburg, Germany

Status

Not yet recruiting

Address

Research Site

Freiburg, , 79106

Research Site, Hamburg, Germany

Status

Not yet recruiting

Address

Research Site

Hamburg, , 22143

Research Site, Leipzig, Germany

Status

Not yet recruiting

Address

Research Site

Leipzig, , 04107

Research Site, Munich, Germany

Status

Not yet recruiting

Address

Research Site

Munich, , 80809

Research Site, Białystok, Poland

Status

Not yet recruiting

Address

Research Site

Białystok, , 15-351

Research Site, Bydgoszcz, Poland

Status

Withdrawn

Address

Research Site

Bydgoszcz, , 85-065

Research Site, Bydgoszcz, Poland

Status

Not yet recruiting

Address

Research Site

Bydgoszcz, , 85-065

Research Site, Elblag, Poland

Status

Not yet recruiting

Address

Research Site

Elblag, , 82-300

Research Site, Gdynia, Poland

Status

Not yet recruiting

Address

Research Site

Gdynia, , 81-338

Research Site, Lodz, Poland

Status

Withdrawn

Address

Research Site

Lodz, , 90-302

Research Site, Lodz, Poland

Status

Not yet recruiting

Address

Research Site

Lodz, , 90-302

Research Site, Lublin, Poland

Status

Not yet recruiting

Address

Research Site

Lublin, , 20-607

Research Site, Poznan, Poland

Status

Not yet recruiting

Address

Research Site

Poznan, , 61-113

Research Site, Puławy, Poland

Status

Withdrawn

Address

Research Site

Puławy, , 24-100

Research Site, Puławy, Poland

Status

Not yet recruiting

Address

Research Site

Puławy, , 24-100

Research Site, Staszów, Poland

Status

Withdrawn

Address

Research Site

Staszów, , 28-200

Research Site, Staszów, Poland

Status

Not yet recruiting

Address

Research Site

Staszów, , 28-200

Research Site, Toruń, Poland

Status

Recruiting

Address

Research Site

Toruń, , 87-100

Research Site, Warszawa, Poland

Status

Not yet recruiting

Address

Research Site

Warszawa, , 00-874

Research Site, Zamosc, Poland

Status

Not yet recruiting

Address

Research Site

Zamosc, , 22-400

Research Site, Barcelona, Spain

Status

Withdrawn

Address

Research Site

Barcelona, , 08035

Research Site, Barcelona, Spain

Status

Not yet recruiting

Address

Research Site

Barcelona, , 08035

Research Site, Cordoba, Spain

Status

Withdrawn

Address

Research Site

Cordoba, , 14004

Research Site, Cordoba, Spain

Status

Not yet recruiting

Address

Research Site

Cordoba, , 14004

Research Site, Galdakao, Spain

Status

Not yet recruiting

Address

Research Site

Galdakao, , 48960

Research Site, La Coruña, Spain

Status

Not yet recruiting

Address

Research Site

La Coruña, , 15006

Research Site, Madrid, Spain

Status

Withdrawn

Address

Research Site

Madrid, , 28034

Research Site, Madrid, Spain

Status

Not yet recruiting

Address

Research Site

Madrid, , 28034

Research Site, Malaga, Spain

Status

Not yet recruiting

Address

Research Site

Malaga, , 29010

Research Site, Sabadell, Spain

Status

Not yet recruiting

Address

Research Site

Sabadell, , 08208

Research Site, Santiago de Compostela, Spain

Status

Not yet recruiting

Address

Research Site

Santiago de Compostela, , 15705

Research Site, Valencia, Spain

Status

Not yet recruiting

Address

Research Site

Valencia, , 46010

Research Site, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Research Site

Cambridge, , CB2 0QQ

Research Site, Enfield, United Kingdom

Status

Recruiting

Address

Research Site

Enfield, , EN3 4GS

Research Site, Leeds, United Kingdom

Status

Not yet recruiting

Address

Research Site

Leeds, , LS7 4SA

Research Site, Leeds, United Kingdom

Status

Withdrawn

Address

Research Site

Leeds, , LS7 4SA

Research Site, London, United Kingdom

Status

Recruiting

Address

Research Site

London, , EC2Y 8EA

Research Site, London, United Kingdom

Status

Withdrawn

Address

Research Site

London, , EC2Y 8EA

Research Site, Northwood, United Kingdom

Status

Not yet recruiting

Address

Research Site

Northwood, , HA6 2RN

Research Site, Preston, United Kingdom

Status

Recruiting

Address

Research Site

Preston, , PR1 6YA

Research Site, Rochdale, United Kingdom

Status

Recruiting

Address

Research Site

Rochdale, , OL11 4AU

Research Site, Rochdale, United Kingdom

Status

Withdrawn

Address

Research Site

Rochdale, , OL11 4AU

Research Site, Salford, United Kingdom

Status

Not yet recruiting

Address

Research Site

Salford, , M6 8HD

Research Site, Sidcup, United Kingdom

Status

Not yet recruiting

Address

Research Site

Sidcup, , DA14 6LT