A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain

NCT02184156 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AP-007
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; osteoarthritis of the knee

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1)

  Incidence and severity of adverse events and serious adverse events evaluated at 24 weeks

  24 Weeks

• Change in Knee Pain (Phase 2)

  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.

  Scored at Baseline and 20 Weeks

Secondary Outcomes (1)

• Change in Knee Function (Phase 2)

  Scored at Baseline and 20 Weeks

Study Arms (2)

AMPION™ 4 mL dose

EXPERIMENTAL

4 mL injection of Ampion

Biological: 4 mL injection of Ampion

Placebo 4 mL dose

PLACEBO COMPARATOR

4 mL injection of placebo

Drug: 4 mL injection of Placebo

Interventions

4 mL injection of Ampion BIOLOGICAL

4 mL injection of Ampion

AMPION™ 4 mL dose

4 mL injection of Placebo DRUG

Also known as: Saline

Placebo 4 mL dose

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Ampio Pharmaceuticals

Englewood, Colorado, 80112, United States

Location

Related Publications (1)

• Schwappach J, Dryden SM, Salottolo KM. Preliminary Trial of Intra-articular LMWF-5A for Osteoarthritis of the Knee. Orthopedics. 2017 Jan 1;40(1):e49-e53. doi: 10.3928/01477447-20160926-02. Epub 2016 Sep 30.

  PMID: 27684085 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The Phase 2 study was underpowered to detect a statistically significant change in function.

Results Point of Contact

• Title: Dr. Howard Levy / Chief Medical Officer
• Organization: Ampio Pharmaceuticals

clinicaltrials@ampiopharma.com

7204376500

Study Officials

• Howard Levy, M.D.

  Ampio Pharmaceuticals. Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 9, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 30, 2022
• Results First Posted: September 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)