Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis

NCT05796765 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: AIOA005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to determine the safety and efficacy of the 40 mg and 100 mg doses of allogeneic micronized dehydrated human amnion/chorion membrane (micronized DHACM) injectable compared to 0.9% sodium chloride injection, placebo control for the treatment of knee osteoarthritis

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Change in WOMAC pain subscale score between baseline and Day 180

  Efficacy Endpoint

  180 days

• Change in WOMAC function subscale score between baseline and Day 180

  Efficacy Endpoint

  180 days

• Proportions of subjects who report treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Safety Endpoint

  365 days

Secondary Outcomes (5)

• Proportion of subjects who report greater than the minimal clinically important difference (MCID) improvement in WOMAC pain and function compared to baseline at Day 90 or Day 180

  90 Days, 180 Days

• Change in SF-36 physical component score (PCS), mental component score (MCS), and domain scores between baseline and Day 90 or Day 180

  90 Days, 180 Days

• Change in patient's global assessment (PtGA) of the target joint between baseline and Day 90 or Day 180

  90 Days, 180 Days

• Proportion of subjects who report greater than the minimal clinically important difference (MCID) improvement in patient's global assessment (PtGA) compared to baseline at Day 90 or Day 180

  90 Days, 180 Days

• Number of OMERACT-OARSI "Strict Responders" at Day 90 or Day 180

  90 Days, 180 Days

Other Outcomes (5)

• Proportion of subjects taking acetaminophen/paracetamol or any other non-study pain medication

  365 Days

• Average amount (milligrams) of rescue medication used between Day 8 and Day 180 and between Day 180 and Day 365

  180 Days, 365 Days

• Time to initiation of use of acetaminophen/paracetamol or any other non-study pain medication, excluding the first 7 days following injection

  365 Days

Study Arms (3)

Micronized DHACM 40 mg

EXPERIMENTAL

Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP

Biological: Micronized DHACM 40 mg

Micronized DHACM 100 mg

EXPERIMENTAL

Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP

Biological: Micronized DHACM 100 mg

Saline

PLACEBO COMPARATOR

Injection of 2.5 ml, 0.9% Sodium Chloride, USP

Drug: Saline

Interventions

Micronized DHACM 40 mg BIOLOGICAL

Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP

Micronized DHACM 40 mg

Micronized DHACM 100 mg BIOLOGICAL

Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP

Micronized DHACM 100 mg

Saline DRUG

Injection of 2.5 ml, 0.9% Sodium Chloride, USP

Saline

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is age ≥ 21 and ≤ 80 years.
• Subject has a diagnosis of primary OA of the target knee (as per American College of Rheumatology clinical and radiological criteria) with OA symptoms (as reported by the subject) that have been present for at least 6 months prior to Screening.
• Subject has Grade 2 or 3 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.
• Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
• Subject must have a WOMAC pain score ≥ 4 and ≤ 9 out of 10 in target knee, at screening and baseline.
• Subject must have tried and failed to adequately respond to 2 knee OA standard of care (SOC) therapies, including at least one pharmacological treatment, for a minimum of 3 months. SOC for knee OA include non-pharmacological (exercise, weight loss, knee braces, cane) and pharmacological treatments (topical nonsteroidal anti-inflammatory drugs \[NSAIDs\], oral NSAIDs, and intra-articular corticosteroids).
• Subject must have a WOMAC pain subscale score in contralateral knee less than 4 out of 10, at screening and baseline visits.
• Subject who is identified as having taking analgesics at their initial screening visit 1a must be willing to abstain from analgesics for a washout period of 5 half-lives of the analgesic plus 48 hours and return for screening visit 1b where WOMAC pain can be collected analgesic-free.
• Subject must be willing to abstain from use of rescue medication (acetaminophen/paracetamol) for at least 72 hours prior to all study visits subsequent to screening.
• For male subjects:
• Subject must agree to use highly effective contraception throughout the study.
• Subject must agree not to donate sperm during the study.
• For female subjects:
• Subject is surgically sterile; or
• Has been amenorrheic for at least 1 year and is over the age of 55 years; or

You may not qualify if:

• Subject has Grade 1 or 4 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.
• Subject has a BMI greater than 40 kg/m\^2.
• Subject has a clinical effusion (3+) of the target knee according to the Stroke Test grading system.
• Subject has symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an intra-articular loose body.
• Subject has any active infection of the target knee, and/or any active systemic or local infection.
• Subject has a history of allergy or sensitivity to any of the investigational product components, including aminoglycoside antibiotics.
• Symptomatic pain in either or both hips that exceeds that of the target knee, as determined by investigator assessment.
• Significant radicular back pain, as determined by investigator assessment.
• Subject has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
• Subject has documented history of gout or pseudogout.
• Subject has fibromyalgia or any other chronic pain disorder.
• Subject has an autoimmune disease or a known history of having acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV).
• Subject has received any of the following to the target knee:
• Intra-articular hyaluronic acid (HA) injection within 24 weeks prior to screening;
• Intra-articular short-acting corticosteroid such as triamcinolone within 12 weeks prior; if long-acting (Zilretta) within 5 months prior to screening;

Sponsors & Collaborators

• MiMedx Group, Inc.: lead
• Rho, Inc.: collaborator
• United BioSource, LLC: collaborator
• NBCD A/S: collaborator

Study Sites (14)

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

AppleMed Research Group, LLC

Miami, Florida, 33126, United States

Location

Health and Life Research Institute, LLC

Miami, Florida, 33155, United States

Location

Vista Health Research, LLC

Miami, Florida, 33176, United States

Location

Premier Medical Associates

The Villages, Florida, 32159, United States

Location

Elite Clinical Trials, LLLP

Blackfoot, Idaho, 83221, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

University Orthopedics Center - Altoona

Altoona, Pennsylvania, 16602, United States

Location

University Orthopedics Center - State College

State College, Pennsylvania, 16801, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Piedmont Research Partners, LLC

Fort Mill, South Carolina, 29707, United States

Location

ClinRX Research Joseph, Inc.

Carrollton, Texas, 75007, United States

Location

J. Lewis Research Inc. / Foothill Family Clinic Draper

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. The injecting investigator(s) will not be blinded, but subjects and the evaluators performing safety and efficacy assessments will be blinded as to which treatment the subject received until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: March 24, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)