Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

NCT03988023 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: AP-013
• Study Type: interventional
• Target: 1,043
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.

Conditions

Severe Osteoarthritis of the Knee

Keywords

Osteoarthritis; osteoarthritis of the knee

Outcome Measures

Primary Outcomes (2)

• Change in Knee 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.

  Scored at Baseline and 12 Week

• Change in Knee Function

  Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.

  Scored at Baseline and 12 weeks.

Study Arms (2)

AMPION™ 4 mL dose

EXPERIMENTAL

4 mL injection of Ampion

Biological: Ampion

Saline

PLACEBO COMPARATOR

4 mL injection of placebo

Drug: Saline

Interventions

Ampion BIOLOGICAL

4 mL injection of Ampion

AMPION™ 4 mL dose

Saline DRUG

Saline solution, 4 mL, single intra-articular injection

Also known as: 0.9% Saline

Saline

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
• Must be ambulatory
• Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OAK and supported by radiological evidence (Kellgren-Lawrence Grade 4) that is not older than 6 months prior to the date of screening
• Moderate to moderately-severe osteoarthritis (OA) pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 as measured by 5-point Likert Pain Subscale) assessed at screening
• Ability to temporarily discontinue nonsteroidal anti-inflammatory drug (NSAID) for 48 hours prior to scheduled clinical efficacy evaluations
• No analgesia (including acetaminophen \[paracetamol\]) taken 12 hours prior to an efficacy measure
• No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).

You may not qualify if:

• As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
• A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
• Presence of tense effusions
• Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
• Isolated patella femoral syndrome, also known as chondromalacia
• Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
• Major injury to the index knee within the 12 months prior to screening
• Severe hip osteoarthritis ipsilateral to the index knee
• Any pain that could interfere with the assessment of index knee pain (e.g. 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 randomization or likely to be changed during the duration of the study
• Use of the following medications:
• No IA injected pain medications in the study knee during the study
• No analgesics containing opioids. NSAIDs may be continued at levels preceding the study, however may not be used 48 hours prior to efficacy evaluations, and acetaminophen is available as a rescue medication during the study from the provided supply
• No topical treatment on osteoarthritis index knee during the study
• No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Denver Metro Orthopedics

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

aspartyl-alanyl-diketopiperazine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: June 24, 2019
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)