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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Amniotic Suspension Allograft Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 474 participants
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
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
Actual Study Start Date : September 6, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: ASA
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
 Biological: Amniotic Suspension Allograft
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Placebo Comparator: Placebo
Participants receive a single IA injection of 4 mL of normal saline
 Drug: Placebo
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06000410


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

Locations
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Sponsors and Collaborators
Organogenesis
More Information
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Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT06000410    
Other Study ID Numbers: 22 OA 003 ASA
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organogenesis:
Osteoarthritis
Knee
Arthritis
 Joint Disease
Musculoskeletal Diseases
Rheumatic Diseases
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases