Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

Study Overview
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Brief Summary
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The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Bone morphogenetic protein 7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. >40 years Radiographic evidence of at least one osteophyte in either knee at screening Exclusion Criteria Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia) Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily. Received arthroscopic or open surgery to the index knee within 6 months of screening History of joint replacement surgery (index knee). Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening Long acting hyaluronic acid injection of the index knee within 6 months of screening History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia. History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ. Female subject with reproductive capability.

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>0.03 mg/ml BMP-7 or placebo via intraarticular knee injection | Drug: Bone morphogenetic protein 7<br>* Single intraarticular injection of BMP-7 or placebo on Day 1<br>|
| Experimental: Cohort 2<br>0.1 mg/ml BMP-7 or placebo via intraarticular knee injection | Drug: Bone morphogenetic protein 7<br>* Single intraarticular injection of BMP-7 or placebo on Day 1<br>|
| Experimental: Cohort 3<br>0.3 mg/ml BMP-7 or placebo via intraarticular knee injection | Drug: Bone morphogenetic protein 7<br>* Single intraarticular injection of BMP-7 or placebo on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (physical examination, vital signs, clinical laboratory measurements, adverse events) |  | Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain and function |  | Baseline, Week 4, Week 8, Week 12, Week 24 | 
| Patient and physician global VAS |  | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 | 
| Quality of life measurement (SF-36) and pain medication use |  | Baseline, Week 4, Week 8, Week 12, Week 24 |