Phase 2
Completed N=345
A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee
Painful Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT04675034 ↗
Enrolled (actual)
345
Serious AEs
4.1%
Results posted
Feb 2025
Primary outcomePrimary: Change From Baseline in Weekly Average of Daily Numerical Rating Scale (NRS) Pain Score to Week 12 — -2.19; -3.00; -2.83; -2.81 Unit on a scale — p=0.360
Summary
This is a Phase IIb randomised, double-blind, placebo-controlled, dose-response study in participants 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 participants with moderate to severe chronic pain persistent for 3 months or more not adequately controlled by standard of care treatments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Average of Daily Numerical Rating Scale (NRS) Pain Score to Week 12 |
-2.19; -3.00; -2.83; -2.81; -2.35 | 0.360 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale to Week 12 |
-1.88; -2.88; -2.62; -2.57; -2.62 | — |
| SECONDARY Change From Baseline in WOMAC Physical Function Subscale to Week 12 |
-1.48; -2.56; -2.45; -2.22; -2.14 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment (PGA) of OA to Week 12 |
-0.34; -0.72; -0.81; -0.69; -0.57 | — |
| SECONDARY Change From Baseline in WOMAC Pain Subscale Over Time |
-1.32; -1.79; -1.58; -1.88; -1.30; -1.62 | — |
| SECONDARY Change From Baseline in WOMAC PF Subscale Over Time |
-1.06; -1.64; -1.56; -1.80; -0.96; -1.59 | — |
| SECONDARY Change From Baseline in WOMAC Overall Score Over Time |
-1.11; -1.71; -1.58; -1.88; -1.04; -1.66 | — |
| SECONDARY Change From Baseline in WOMAC Stiffness Scores Over Time |
-1.30; -2.06; -1.85; -2.13; -0.99; -1.88 | — |
| SECONDARY Change From Baseline in PGA of OA Over Time |
-0.35; -0.56; -0.67; -0.42; -0.37; -0.48 | — |
| SECONDARY Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition |
47.7; 62.5; 61.8; 59.7; 40.6; 59.3 | — |
| SECONDARY Percentage of Participants With Improvement of >= 2 Points in PGA of OA |
9.7; 9.7; 16.7; 12.3; 7.0; 8.9 | — |
| SECONDARY Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time |
-1.62; -1.86; -1.97; -2.26; -1.10; -1.88 | — |
| SECONDARY Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time |
34.8; 34.4; 41.5; 43.9; 21.5; 47.5 | — |
| SECONDARY Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time |
30.2; 39.7; 36.5; 50.8; 24.1; 40.4 | — |
| SECONDARY Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time |
30.2; 42.9; 39.7; 47.7; 22.4; 47.4 | — |
| SECONDARY Serum Concentration of MEDI7352 |
326.863; 681.322; 2149.062; 3582.265; 50.337; 144.242 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352 |
52; 49; 42; 52; 6; 6 | — |
| SECONDARY ADA Titre in Participants Who Were ADA Positive at Baseline and/or Post-baseline |
960.0; 960.0; 960.0; 720.0; 240.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
51; 45; 54; 51; 41; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Physical Examination Reported as TEAEs |
0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Total Neuropathy Score-Nurse (TNSn) Over Time |
1.5; 1.4; 1.0; 1.2; 1.5; 1.3 | — |
| SECONDARY Change From Baseline in Weight (kg) to Week 12 |
-0.25; 0.10; 0.34; -0.03; -0.34 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as TEAEs |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Change From Baseline in Survey of Autonomic Symptoms (SAS) Total Impact Score |
-1.5; -1.1; -0.9; -1.6; -0.8 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs |
16; 5; 10; 12; 8; 0 | — |
| SECONDARY Change From Baseline in C-reactive Protein Level to Week 12 |
-2.55; -3.34; -3.30; -3.68; -2.38 | — |
| SECONDARY Number of Participants With Injection Site Reactions |
2; 3; 0; 4; 0 | — |
| SECONDARY Number of Participants With Abnormal X-ray and/or Magnetic Resonance Imaging (MRI) of Large Joints |
1; 0; 0; 1; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
- 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.
- 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.
- The participant must be willing and able to discontinue all analgesic therapy with nonsteroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (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.
Exclusion Criteria
- Requires current treatment with another biologic therapeutic agent, disease-modifying antirheumatic drug (DMARD), or other immunosuppressants.
- Previously received any form of anti-nerve growth factor (NGF); received anti-tumour necrosis factors (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).
- Currently receiving strong opioids for any indication.
- Participation in another clinical study with an IP or device within 60 days or 5 half-lives, whichever is longer, prior to screening.
- Plasma donation within 28 days of screening or any blood donation or blood loss > 500 mL within 2 months of screening.
- Previous allogeneic bone marrow or stem cell transplant.
- Received nonleukocyte-depleted whole blood transfusion within 120 days of the genetic research sample collection, if participating in the optional genetic research.
- Involvement in the planning and/or conduct of the study.
Data sourced from ClinicalTrials.gov (NCT04675034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.