Clinical trial NCT06000410: A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients with Osteoarthritis of the Knee
Official title: A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients with Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Knee
Arthritis
Joint Disease
Musculoskeletal Diseases
Rheumatic Diseases
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, multicenter, randomized, double-blind, placebo-controlled study of ASA in patients with OA of the knee. Patients will be randomly assigned in a 1:1 ratio to receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
timeFrame: Baseline to Week 26
measure: The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months
timeFrame: Baseline to Week 26
measure: The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Tempe
country: United States
facility: Fiel Family & Sports Medicine
state: Arizona
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Napa
country: United States
facility: Neurovations Research
state: California
city: Norco
country: United States
facility: Infinity Clinical Research
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: Redwood City
country: United States
facility: Stanford Medicine
state: California
city: San Diego
country: United States
facility: TriWest Research Associates
state: California
city: Miami
country: United States
facility: AppleMed Research Group, LLC.
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Atlanta
country: United States
facility: CenExcel/ACMR
state: Georgia
city: Newnan
country: United States
facility: Vista Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Clinical Research Institute Inc.
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Orland Park
country: United States
facility: Advanced Quality Medical Research, Inc
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center
state: Indiana
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates M.D., P.A.
state: Maryland
city: Burlington
country: United States
facility: Skylight Health Research
state: Massachusetts
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboriation, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Burleson
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Carrollton
country: United States
facility: ClinRXResearch INC
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References: