Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)

Study Overview
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Brief Summary
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This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

Detailed Description
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This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.

Official Title
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A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: CNTX-4975


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 40 years or over. Body mass index (BMI) of 35 or less. History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months. X-Ray of the target knee. Willing and able to complete the study procedures. Exclusion Criteria: Female patients who are pregnant or lactating or who plan to get pregnant. Clinically significant form of joint disease other than OA. Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study. Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty. Arthroscopic surgery on the target knee within 6 months.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100-200 µg CNTX-4975<br>single dose | Drug: CNTX-4975<br>* Testing a range of dosing configurations to optimize patient tolerability<br>|
| Experimental: 300-425 µg CNTX-4975<br>Total dose delivered as two separate lower doses | Drug: CNTX-4975<br>* Testing a range of dosing configurations to optimize patient tolerability<br>|
| Experimental: 600-700 µg CNTX-4975<br>Total dose delivered as two separate lower doses | Drug: CNTX-4975<br>* Testing a range of dosing configurations to optimize patient tolerability<br>|
| Experimental: 800 µg CNTX-4975<br>Total dose delivered as two separate lower doses | Drug: CNTX-4975<br>* Testing a range of dosing configurations to optimize patient tolerability<br>|
| Experimental: 900-1000 µg CNTX-4975<br>Total dose delivered as two separate lower doses | Drug: CNTX-4975<br>* Testing a range of dosing configurations to optimize patient tolerability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975 |  | 12 Weeks | 
| Change from baseline to Week 12 in WOMAC subscale score |  | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee