Phase 2
Completed N=7
A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain
Source: ClinicalTrials.gov NCT02184156 ↗Enrolled (actual)
7
Serious AEs
6.4%
Results posted
Sep 2022
Primary outcomePrimary: Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1) — 0; 15 events
Summary
Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee.
In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related AEs, enrollment will be initiated in Phase 2 of the study.
Phase 2 will evaluate the efficacy of 3 intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1) |
0; 15 | — |
| PRIMARY Change in Knee Pain (Phase 2) |
-1.41; -0.85 | 0.02 sig |
| SECONDARY Change in Knee Function (Phase 2) |
-1.27; -0.98 | 0.25 |
Eligibility Criteria
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
- Male or female, 40 years to 85 years old (inclusive)
- Ambulatory
- Index knee must have been symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II-IV) acquired at Screening
- Moderate to moderately severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Pain Subscale) assessed at Screening and confirmed at randomization
- Moderate to moderately severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drugs [NSAIDs], which have not changed in the 4 weeks prior to Screening, had been used)
- No analgesia taken 24 hours before efficacy measure
Exclusion Criteria
- As a result of medical review and screening investigation, the Principal Investigator considered the subject unfit for the study
- Previous Ampion injection
- Known clinically significant liver abnormality (eg, cirrhosis, transplant, etc.)
- History of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin was not an exclusion criterion)
- History of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
- Presence of tense effusions in the index knee
- Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator
- Isolated patella femoral syndrome, also known as chondromalacia in the index knee
- Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (eg, cancer, congenital defects, spine OA)
- Major injury to the index knee within the 12 months prior to Screening
- Severe hip OA ipsilateral to the index knee
- Any pain that could interfere with the assessment of index knee pain (eg, pain in any other part of the lower extremities, pain radiating to the knee)
- Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study
- Use of any of the following medications:
- IA-injected pain medications in the index knee during the study
- Analgesics containing opioids (NSAIDs were allowed at the levels preceding the study and acetaminophen was available as rescue medication during the study from the provided supply)
- Topical prescription treatment on the index knee during the study
- Significant anticoagulant therapy (eg, heparin or enoxaparin) during the study (aspirin and clopidogrel were allowed)
- Systemic treatments that could interfere with safety or efficacy assessments during the study
- Immunosuppressants
- Corticosteroids >10 mg prednisolone equivalent per day or corticosteroids at doses ≤10 mg prednisolone equivalent that had been changed during the study
- Any human albumin treatment in the 3 months before randomization
Data sourced from ClinicalTrials.gov (NCT02184156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.