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

Phase 2

Completed

• Conditions: Painful Osteoarthritis of the Knee
• Interventions: Biological: MEDI7352; Biological: Placebo

• Registration Number: NCT04675034
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2020-11-23
• Study Start: 2020-12-02
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Primary Completion: 2023-08-16
• Study Completion: 2023-08-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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.

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Exclusion Criteria

1. Requires current treatment with another biologic therapeutic agent, DMARD, or other Immunosuppressants.
2. Previously received any form of anti-NGF; received anti-TNFs including but not limited to golimumab, certolizumab, infliximab, adalimumab, etanercept, or rituximab within 12 months prior to screening, or other biological DMARDs (including but not limited to abatacept, tocilizumab, and tofacitinib), or other immunosuppressants within 6 months prior to screening (with the exception of inhaled or topical corticosteroids).
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 > 500 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	MEDI7352	Dose A: MEDI7352 Q2W
Cohort 3	MEDI7352	Dose C: MEDI7352 Q2W
Cohort 2	MEDI7352	Dose B: MEDI7352 Q2W
Cohort 4	MEDI7352	Dose D: MEDI7352 Q2W
Cohort 5:	Placebo	Placebo to match MEDI7352 Q2W

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale pain scores	12 weeks	Change in the weekly average of daily NRS pain scores from baseline to Week 12. Average daily pain scores in the target joint will be recorded from a scale of 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours.

Secondary Outcome Measures

Name	Time	Method
ADA titre	12 weeks	Serum concentration of ADA titre
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale from	12 Weeks	Change in the WOMAC pain subscale from baseline to Week 12.; The WOMAC pain subscale consists of 5 questions assessing the participant's pain due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 5 questions, where higher scores represent higher pain
Physician Global Assesment (PGA of OA)	12 Weeks	Change in the PGA of OA from baseline to Week 12.; The PGA of OA is a 5-point scale used to assess symptoms and activity impairment due to OA of the knee. Participants are asked to identify a number from 1 = very good (asymptomatic and no limitation to normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Percentage of responders as measured by the OARSI responder index using the OMERACT-OARSI	Weeks 2, 4, 8, 12, and 18	Percentage of responders as measured by the OARSI responder index using the OMERACT-OARS (Outcome Measures in Rheumatology Clinical Trials -OMERACT and Osteoarthritis Research Society International OARSI) at Weeks 2, 4, 8, 12, and 18
Clinical laboratory assessments	Through study completion, an average of 10 months	Number of Participants with abnormal laboratory values
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function	12 Weeks	Change in the WOMAC physical function subscale from baseline to Week 12; The WOMAC physical function subscale consists of 17 questions assessing the participant's difficulty in performing activities of daily living due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 17 questions, where higher scores represent worse function
Anti-drug Antibodies (ADA)	through study completion, an average of 10 months	Presence of ADA to MEDI7352
Vital Signs (Blood Pressure) in mmHg	Through study completion, an average of 10 months	Change from baseline supine and standing blood pressure in all participants
Adverse Events	Through study completion, an average of 10 months	Number of Participants with adverse events and serious adverse events
Vital Signs (Respiratory Rate) in breaths per minute	Through study completion, an average of 10 months	Change from baseline respiratory rate in all participants
Vital Signs (Temperature) in °C	Through study completion, an average of 10 months	Change from baseline temperature measurements in all participants
concentration of MEDI7352	through study completion, an average of 10 months	Serum concentration of MEDI7352
Vital Signs (Heart Rate) in beats per minute	Through study completion, an average of 10 months	Change from baseline heart rate in all participants

Trial Locations

Locations (1)

Research Site; 🇬🇧 Shipley, United Kingdom