Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

Detailed Description
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The objectives of the study are to assess FX005, as compared to placebo control, for: Safety and tolerability Analgesic effect Pharmacokinetics Analgesic effect will be assessed using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.

Official Title
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A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: FX005
* Drug: Placebo 1 (Carrier)
* Drug: Placebo 2 (Diluent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥40 years of age Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological) Kellgren-Lawrence grades II or III Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee Body mass index ≤ 40 kg/m2 Willingness to abstain from use of restricted medications during the study Willingness and ability to comply with the study procedures and visit schedule Exclusion Criteria: Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee Clinically apparent tense effusion in index knee Presence of surgical hardware or other foreign body in the index knee Clinical signs and symptoms of active knee infection or crystal disease Intra-articular corticosteroid within 3 months of Screening Intra-articular hyaluronic acid within 6 months of Screening Other intra-articular therapy within 3 months of Screening Prior arthroscopic or open surgery of the index knee within 12 months of Screening Planned/anticipated surgery of the index knee during the study period History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness Skin breakdown at the knee where the injection would take place Women who are pregnant, nursing or likely to become pregnant during the time of the study Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FX005<br> | Drug: FX005<br>* Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase)<br>|
| Placebo Comparator: Placebo 1 (Carrier)<br> | Drug: Placebo 1 (Carrier)<br>* Single intra-articular injection<br>|
| Placebo Comparator: Placebo 2 (Diluent)<br> | Drug: Placebo 2 (Diluent)<br>* Single intra-articular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the WOMAC A score (pain subscale) |  | at 4 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in WOMAC A score (pain subscale) |  | over 4, 8 and 12 weeks post treatment | 
| Change from baseline for WOMAC A score (pain subscale) |  | at 2, 8 and 12 weeks post treatment | 
| Change from baseline for WOMAC B score (stiffness subscale) |  | at 2, 4, 8 and 12 weeks post treatment | 
| Change from baseline for WOMAC C score (function subscale) |  | at 2, 4, 8 and 12 weeks post treatment | 
| Change from baseline for WOMAC A1 response (pain on walking) |  | at 2, 4, 8 and 12 weeks post treatment | 
| Change from baseline for WOMAC A1 response (pain on walking) |  | over 4, 8 and 12 weeks post treatment | 
| Change from baseline for WOMAC total score |  | at 2, 4, 8 and 12 weeks post treatment | 
| Change from baseline for ICOAP intermittent pain score |  | at 2, 4, 8 and 12 weeks post treatment | 
| Change from baseline for ICOAP constant pain score |  | at 2, 4, 8 and 12 weeks post treatment | 
| Change from baseline for ICOAP total score |  | at 2, 4, 8 and 12 weeks post treatment | 
| Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria |  | at 4, 8 and 12 weeks post treatment | 
| Change in patient's global assessment score |  | at 4, 8 and 12 weeks post treatment | 
| Change in clinical observer's global assessment score |  | at 4, 8 and 12 weeks post treatment | 
| Average weekly consumption of analgesic medications |  | over 12 weeks post treatment | 
| Incidence of treatment emergent adverse events |  | up to 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, intra-articular, safety, efficacy, pharmacokinetics, pain, Osteoarthritis