AP-007 Study to Evaluate Safety and Exploratory Efficacy of Three Intra-articular Injections of Ampion in the Knee of Adults With Pain Due to Osteoarthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 5/6/2016 |
| Start Date: | June 2014 |
| End Date: | October 2015 |
A Prospective Phase I/II Study to Evaluate the Safety and Exploratory Efficacy of Three Intra-articular Injections of Ampion™ (4 ML) Administered Two Weeks Apart in Adults With Pain Due to Osteoarthritis of the Knee
In this Phase I/Phase II clinical trial, 7 eligible patients with OA of the knee will
receive Ampion™ 4 mL administered as three IA injections, 2 weeks apart. In the absence of
serious drug-related AEs of unanticipated drug-related AEs, enrollment will be initiated in
Phase II of the study.
In Phase II, a total of 30 eligible patients with OA knee pain will be randomized 1:1 to
receive either the active drug (Ampion™ 4 mL) or placebo as three IA injections, 2 weeks
apart.
receive Ampion™ 4 mL administered as three IA injections, 2 weeks apart. In the absence of
serious drug-related AEs of unanticipated drug-related AEs, enrollment will be initiated in
Phase II of the study.
In Phase II, a total of 30 eligible patients with OA knee pain will be randomized 1:1 to
receive either the active drug (Ampion™ 4 mL) or placebo as three IA injections, 2 weeks
apart.
In Phase I of this study, 7 eligible patients with OA knee pain will be enrolled and treated
with 3 IA injections of active drug (Ampion™ 4 mL) at Baseline (Day 0) and Weeks 2 and 4 to
the knee. The Medical Monitor will conduct a safety evaluation after all 7 treated patients
complete the Week 4 follow-up evaluation. Enrollment will be initiated in Phase II if no
serious drug-related adverse events or unanticipated drug-related adverse events are
observed. Pending safety review, these patients will continue to Week 52.
In Phase II, 30 eligible patients with OA knee pain will be enrolled in the randomized,
placebo-controlled, double-blind phase of the study. Patients will be randomized 1:1 to
receive three (3) IA injections of either the active drug (Ampion™ 4 mL) or placebo at
Baseline (Day 0) and Weeks 2 and 4 to the knee.
The clinical effects of treatment on OA pain will be evaluated for all patients during
in-clinic visits at Screening, Baseline (Day 0) and Weeks 2, 4, 6, 12, 18, 20, 24 and 52
using the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis
Index 3.1, and the Patient's Global Assessment of disease severity (PGA).
with 3 IA injections of active drug (Ampion™ 4 mL) at Baseline (Day 0) and Weeks 2 and 4 to
the knee. The Medical Monitor will conduct a safety evaluation after all 7 treated patients
complete the Week 4 follow-up evaluation. Enrollment will be initiated in Phase II if no
serious drug-related adverse events or unanticipated drug-related adverse events are
observed. Pending safety review, these patients will continue to Week 52.
In Phase II, 30 eligible patients with OA knee pain will be enrolled in the randomized,
placebo-controlled, double-blind phase of the study. Patients will be randomized 1:1 to
receive three (3) IA injections of either the active drug (Ampion™ 4 mL) or placebo at
Baseline (Day 0) and Weeks 2 and 4 to the knee.
The clinical effects of treatment on OA pain will be evaluated for all patients during
in-clinic visits at Screening, Baseline (Day 0) and Weeks 2, 4, 6, 12, 18, 20, 24 and 52
using the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis
Index 3.1, and the Patient's Global Assessment of disease severity (PGA).
Inclusion Criteria:
- Clinical diagnosis and radiological evidence of symptomatic osteoarthritis of the
knee
- Moderate to severe pain
Exclusion Criteria:
- Other conditions in the knee, e.g., crystal arthropathies, septic necrosis, joint
replacement, major injury within 12 months prior to screening, tense effusions
- Requires ongoing treatment with intra-articular pain medications or systemic
corticosteroids
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