A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients with Osteoarthritis of the Knee
- Conditions
- Knee Osteoarthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06000410
- Lead Sponsor
- Organogenesis
- Brief Summary
This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.
- Detailed Description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study of ASA in patients with OA of the knee. Initially, 474 subjects are planned for inclusion in this study using a group sequential design with an interim analyses and a final analysis. Patients will be randomly assigned in a 1:1 ratio to receive a single intra-articular (IA) injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline on Day 1.
They will have serial assessments of knee pain, function, and symptoms scores, as well as safety assessments for up to 52 weeks after administration of the study drug.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 474
- Males or females 18 years of age or older
- Diagnosis of OA of the index knee by a combination of clinical and radiographic findings.
- OA of the index knee with Kellgren and Lawrence radiographic classification (Grades 2-4 inclusive),
- Patients who have failed to adequately respond for at least 6 months to at least two osteoarthritis therapies within the last 12 months
- Overall index knee pain score above minimum required WOMAC Pain scale.
- Body mass index < 40 kg/m2
- Using birth control, sterile or post-menopausal.
- Able to understand and provide written informed consent
- Kellgren and Lawrence radiographic grade 1 OA of the knee
- Use of pain medication less than 5 days before the baseline visit
- Regular use of anticoagulants
- Symptoms that could indicate meniscal displacement or an IA loose body.
- Corticosteroid injection into the index knee within 3 months prior to screening.
- Viscosupplement or any other autologous or allogeneic product into the index knee within 6 months prior to screening.
- Patients with known hypersensitivity reactions to ASA or any of its constituents.
- Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study
- Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study
- Acute index knee trauma within 3 months prior to screening
- Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening.
- Contralateral knee pain above limits defined in the protocol
- Current therapy with any immunosuppressive therapy or medical conditions likely to require systemic steroids during the study.
- Any active or systemic infection including infection of the index knee joint or breakdown or disease of the index knee skin/soft tissues.
- Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that would jeopardize patient safety, limit participation, or compromise interpretation of data derived from the patient
- Active alcohol or substance use disorder, or any other reason that would make it unlikely that the patient will comply with study procedures
- Females who are pregnant or lactating
- Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASA Amniotic Suspension Allograft Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) Placebo Placebo Participants receive a single IA injection of 4 mL of normal saline
- Primary Outcome Measures
Name Time Method The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients Baseline to Week 26 The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.
- Secondary Outcome Measures
Name Time Method The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months Baseline to Week 26 The OMERACT-OARSI core domain set for clinical trials in hip and/or knee osteoarthritis responder criteria will be used to assess whether a patient is a responder or not.
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months Baseline to Week 12 The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months Baseline to Week 26 The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.
Related Research Topics
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Trial Locations
- Locations (40)
Central Research Associates, Inc.
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Fiel Family & Sports Medicine
🇺🇸Tempe, Arizona, United States
Horizon Clinical Research
🇺🇸La Mesa, California, United States
Neurovations Research
🇺🇸Napa, California, United States
Infinity Clinical Research
🇺🇸Norco, California, United States
Dream Team Clinical Research
🇺🇸Pomona, California, United States
Stanford Medicine
🇺🇸Redwood City, California, United States
TriWest Research Associates
🇺🇸San Diego, California, United States
AppleMed Research Group, LLC.
🇺🇸Miami, Florida, United States
Gulfcoast Research Institute
🇺🇸Sarasota, Florida, United States
CenExcel/ACMR
🇺🇸Atlanta, Georgia, United States
Vista Clinical Research
🇺🇸Newnan, Georgia, United States
Chicago Clinical Research Institute Inc.
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Advanced Quality Medical Research, Inc
🇺🇸Orland Park, Illinois, United States
MediSphere Medical Research Center
🇺🇸Evansville, Indiana, United States
Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Klein & Associates M.D., P.A.
🇺🇸Hagerstown, Maryland, United States
Skylight Health Research
🇺🇸Burlington, Massachusetts, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Physician Research Collaboriation, LLC
🇺🇸Lincoln, Nebraska, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
NYU Langone Health
🇺🇸New York, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Northwell Health
🇺🇸New York, New York, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
West Clinical Research
🇺🇸Morehead City, North Carolina, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Conrad Clinical Research
🇺🇸Edmond, Oklahoma, United States
Tekton Research
🇺🇸Austin, Texas, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Cedar Health Research, LLC
🇺🇸Burleson, Texas, United States
ClinRXResearch INC
🇺🇸Carrollton, Texas, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Spokane Joint Replacement Center
🇺🇸Spokane, Washington, United States