xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000410</url>
    </required_header>
    <id_info>
      <org_study_id>22 OA 003 ASA</org_study_id>
      <nct_id>NCT06000410</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Organogenesis</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Organogenesis</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo&#xD;
        in the management of osteoarthritis (OA) symptoms of the knee.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3&#xD;
        study of ASA in patients with OA of the knee. Initially, 474 subjects are planned for&#xD;
        inclusion in this study using a group sequential design with an interim analyses and a final&#xD;
        analysis. Patients will be randomly assigned in a 1:1 ratio to receive a single&#xD;
        intra-articular (IA) injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal&#xD;
        saline on Day 1.&#xD;
  &#xD;
        They will have serial assessments of knee pain, function, and symptoms scores, as well as&#xD;
        safety assessments for up to 52 weeks after administration of the study drug.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients</measure>
      <time_frame>Baseline to Week 26</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months</measure>
      <time_frame>Baseline to Week 26</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months</measure>
      <time_frame>Baseline to Week 26</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months</measure>
      <time_frame>Baseline to Week 12</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">474</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>ASA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants receive a single IA injection of 4 mL of normal saline</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Amniotic Suspension Allograft</intervention_name>
      <description>This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.</description>
      <arm_group_label>ASA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo is 0.9% normal saline: 4 mL to be injected IA.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males or females 18 years of age or older&#xD;
  &#xD;
            -  Diagnosis of OA of the index knee by a combination of clinical and radiographic&#xD;
               findings.&#xD;
  &#xD;
            -  OA of the index knee with Kellgren and Lawrence radiographic classification (Grades&#xD;
               2-4 inclusive),&#xD;
  &#xD;
            -  Patients who have failed to adequately respond for at least 6 months to at least two&#xD;
               osteoarthritis therapies within the last 12 months&#xD;
  &#xD;
            -  Overall index knee pain score above minimum required WOMAC Pain scale.&#xD;
  &#xD;
            -  Body mass index &lt; 40 kg/m2&#xD;
  &#xD;
            -  Using birth control, sterile or post-menopausal.&#xD;
  &#xD;
            -  Able to understand and provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Kellgren and Lawrence radiographic grade 1 OA of the knee&#xD;
  &#xD;
            -  Use of pain medication less than 5 days before the baseline visit&#xD;
  &#xD;
            -  Regular use of anticoagulants&#xD;
  &#xD;
            -  Symptoms that could indicate meniscal displacement or an IA loose body.&#xD;
  &#xD;
            -  Corticosteroid injection into the index knee within 3 months prior to screening.&#xD;
  &#xD;
            -  Viscosupplement or any other autologous or allogeneic product into the index knee&#xD;
               within 6 months prior to screening.&#xD;
  &#xD;
            -  Patients with known hypersensitivity reactions to ASA or any of its constituents.&#xD;
  &#xD;
            -  Knee surgery on the index knee within 12 months prior to screening and/or planned knee&#xD;
               surgery during the study&#xD;
  &#xD;
            -  Knee surgery on the contralateral knee within 6 months prior to screening and/or&#xD;
               planned knee surgery during the study&#xD;
  &#xD;
            -  Acute index knee trauma within 3 months prior to screening&#xD;
  &#xD;
            -  Knee effusion requiring aspiration of the index or contralateral knee within 3 months&#xD;
               prior to screening.&#xD;
  &#xD;
            -  Contralateral knee pain above limits defined in the protocol&#xD;
  &#xD;
            -  Current therapy with any immunosuppressive therapy or medical conditions likely to&#xD;
               require systemic steroids during the study.&#xD;
  &#xD;
            -  Any active or systemic infection including infection of the index knee joint or&#xD;
               breakdown or disease of the index knee skin/soft tissues.&#xD;
  &#xD;
            -  Clinically significant intercurrent illness, medical condition, non-knee pain, or&#xD;
               medical history that would jeopardize patient safety, limit participation, or&#xD;
               compromise interpretation of data derived from the patient&#xD;
  &#xD;
            -  Active alcohol or substance use disorder, or any other reason that would make it&#xD;
               unlikely that the patient will comply with study procedures&#xD;
  &#xD;
            -  Females who are pregnant or lactating&#xD;
  &#xD;
            -  Participation in another clinical trial within the 30 days (or 5 half-lives of the&#xD;
               investigational compound, whichever is longer) before screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Clinical Trials Office</last_name>
      <phone>857-300-1167</phone>
      <email>ClinicalTrials@organo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Spectrum Medical, Inc.</name>
        <address>
          <city>Danville</city>
          <state>Alabama</state>
          <zip>24541</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>April Marshall, RN</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chicago Clinical Research Institute Inc.</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60607</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nursat Deen</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Osteoarthritis</keyword>
    <keyword>Knee</keyword>
    <keyword>Arthritis</keyword>
    <keyword>Joint Disease</keyword>
    <keyword>Musculoskeletal Diseases</keyword>
    <keyword>Rheumatic Diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000410
  org study id: 22 OA 003 ASA
  nct id: NCT06000410
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  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.
  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.
  primary purpose: Treatment
  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.
  measure: 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
  description: 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.
  measure: The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
  time frame: Baseline to Week 26
  description: 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.
  measure: 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
  description: 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.
  measure: The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
  time frame: Baseline to Week 12
  description: 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.
  arm group label: ASA
  arm group type: Experimental
  description: Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants receive a single IA injection of 4 mL of normal saline
  intervention type: Biological
  intervention name: Amniotic Suspension Allograft
  description: This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
  arm group label: ASA
  intervention type: Drug
  intervention name: Placebo
  description: Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Trials Office
  phone: 857-300-1167
  email: ClinicalTrials@organo.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No