Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as of Ampion
AMPION · 10 trials · 8 indications
Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of WOMAC A Pain subscore, WOMAC C Function subscore, and PGA as composite endpoints. A patient in this study will be considered a responder for the purpose of efficacy analysis if the following criteria are met: (1) demonstration of ≥ 50% improvement AND a 1.0-unit change in pain OR 1.0-unit change in function OR If the patient does not meet this criterion, then the patient must demonstrate at least 2 of the following: * Improvement in pain (WOMAC A) ≥20% and a 0.5 point absolute change in pain from Baseline on the 5-point Likert scale * Improvement in function (WOMAC C) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale * Improvement in patient global assessment (PGA) ≥20% and a 0.5 point absolute change in function from Baseline on the 5-point Likert scale
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Incidence and severity of adverse events and serious adverse events evaluated at 24 weeks
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of inhalation Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
The Clinical safety of treatment on base of the thumb will be assessed by recording AEs at all in-clinic visits and the 24-hour, post-injection telephone contact call, by the results of the physical examination of the thumb joint and vital signs (at all in-clinic visits), and by recording prior and concomitant medications including start/stop dates, indication, dose and frequency (at 24 hour post-injection telephone contact call and all in-clinic visits).
| Arm | Type | Description |
|---|---|---|
| AMPION™ 4 mL dose | EXPERIMENTAL | 4 mL injection of Ampion |
| Placebo 4 mL dose | PLACEBO_COMPARATOR | 4 mL injection of Placebo |
| Ampion 4ml dose | EXPERIMENTAL | 4 mL intra-articular injection of Ampion |
| Placebo Solution | PLACEBO_COMPARATOR | 4 mL placebo intra-articular injection |
| Ampion 4 mL Dose | EXPERIMENTAL | 4 mL Injection of Ampion |
| Ampion 10 mL Dose | EXPERIMENTAL | 10 mL Injection of Ampion |
| Placebo 10 mL Dose | PLACEBO_COMPARATOR | 10 mL Injection of Placebo |
| Active | EXPERIMENTAL | Ampion |
| Control | PLACEBO_COMPARATOR | Placebo |
| Ampion | EXPERIMENTAL | Ampion |
| Standard of Care | OTHER | Standard of Care |
| AMPION™ | EXPERIMENTAL | AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA. |
| Saline | EXPERIMENTAL | Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride |
| Name | Type | Description |
|---|---|---|
| 4 mL injection of Ampion | BIOLOGICAL | 4 mL injection of Ampion |
| 4 mL Injection of Placebo | DRUG | 4 mL Injection of Placebo |
| 4 mL injection of AMPION™ | BIOLOGICAL | 4 mL Injection of Ampion |
| 10 mL Injection of Ampion | BIOLOGICAL | 10 mL Injection of Ampion |
| 10 mL Injection of Placebo | DRUG | 10 mL Injection of Placebo |
| Ampion | BIOLOGICAL | Inhaled Ampion |
| Placebo | OTHER | Inhaled Placebo |
| Standard of Care | OTHER | Standard of Care |
| AMPION™ | BIOLOGICAL | AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA. |
| Saline | BIOLOGICAL | Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride |
Inclusion Criteria: * Able to provide written informed consent to participate in the study; * Willing and able to comply with all study requirements and instructions of the site study staff; * Must be ambulatory; * Study knee must have a clinical diagnosis of osteoarthritis (OA) supported by radiol...
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| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
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