A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

• ClinicalTrials.gov Identifier: NCT06000410
• Recruitment Status: Recruiting
• First Posted: August 21, 2023
• Last Update Posted: February 2, 2024
• Sponsor: Organogenesis
• Information provided by (Responsible Party): Organogenesis

Tracking Information

• First Submitted Date: August 14, 2023
• First Posted Date: August 21, 2023
• Last Update Posted Date: February 2, 2024
• Actual Study Start Date: September 6, 2023
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2023)

The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 14, 2023)

• The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months [ Time Frame: 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.
• The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) All clinic staff who may be involved in making assessments of safety will be blinded to treatment assignment.

Primary Purpose: Treatment

• Condition: Knee Osteoarthritis

Intervention

• Biological: Amniotic Suspension Allograft
  This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
• Drug: Placebo
  Matching placebo is 0.9% normal saline: 4 mL to be injected IA.

Study Arms

• Experimental: ASA
  Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
  Intervention: Biological: Amniotic Suspension Allograft
• Placebo Comparator: Placebo
  Participants receive a single IA injection of 4 mL of normal saline
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 14, 2023): 474
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2026
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trials Office; 857-300-1167; ClinicalTrials@organo.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06000410
• Other Study ID Numbers: 22 OA 003 ASA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Organogenesis
• Original Responsible Party: Same as current
• Current Study Sponsor: Organogenesis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Organogenesis
• Verification Date: February 2024