<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/NCT03275064</url>
  </required_header>
  <id_info>
    <org_study_id>CLNA043X2202</org_study_id>
    <secondary_id>2016-004052-30</secondary_id>
    <secondary_id>CTI-194705</secondary_id>
    <nct_id>NCT03275064</nct_id>
  </id_info>
  <brief_title>Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.</brief_title>
  <official_title>A Two-part, Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability and Preliminary Efficacy of Intra-articular LNA043 Injections in Regenerating the Articular Cartilage of the Knee in Patients With Articular Cartilage Lesions (Part A) and in Patients With Knee Osteoarthritis (Part B).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this two-part study is to assess the efficacy, safety and tolerability of&#xD;
      multiple intra-articular (i.a.) injections of LNA043 in regenerating the articular surface in&#xD;
      patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this two-part study is to assess the efficacy, safety and tolerability of&#xD;
      multiple intra-articular (i.a.) injections of LNA043 in regenerating the articular surface in&#xD;
      patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B). In&#xD;
      Part A, this study aims to establish Proof of Concept (PoC), namely regeneration of the&#xD;
      articular cartilage, in order to provide information on the potential clinical utility of&#xD;
      LNA043, with the ultimate goal of replacing current surgical procedures for cartilage repair&#xD;
      with an injectable, less invasive regenerative therapy. In Part B, this study aims at further&#xD;
      evaluating the cartilage anabolic activity of LNA043 in a more severe knee OA population, and&#xD;
      at testing the potential benefit of a higher dose of LNA043 administered i.a. monthly instead&#xD;
      of weekly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">September 6, 2022</completion_date>
  <primary_completion_date type="Actual">September 6, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Articular cartilage bi-layer collagen organisation evaluated with MRI and measured in milliseconds (ms) (Part A only)</measure>
    <time_frame>Up to Week 28</time_frame>
    <description>To assess the efficacy of multiple i.a. injections of LNA043 in regenerating the articular cartilage tissue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with any adverse events, serious adverse events and death (Part A and Part B)</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>To assess safety and local tolerability of multiple i.a. injections of LNA043</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cartilage volume/thickness in the index region (Part B only)</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>To assess the efficacy of multiple i.a. injections of LNA043 in regenerating the articular cartilage tissue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in volume of cartilage defect filling evaluated with MRI (Part A only)</measure>
    <time_frame>Week 16, Week 28</time_frame>
    <description>To assess the extent of the repair cartilage tissue following multiple i.a. injections of LNA043</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration measured in ng/mL (Part A and Part B)</measure>
    <time_frame>Part A: 0 (pre-dose), 15 min, 60 min and 120 min post-dose Week 1, Week 2, Week 3, Week 4; Part B: Week 1, Week 4, Week 9, Week 13, Week 16, Week 28 and Week 52</time_frame>
    <description>To evaluate systemic and local PK of LNA043 following multiple i.a. injections of LNA043</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential immunogenicity of LNA043 presence and characterisation of anti-LNA043 antibodies in serum (Part A and Part B)</measure>
    <time_frame>Week 1, Week 3, Week 6, Week 16, Week 28</time_frame>
    <description>To assess the potential immunogenicity of LNA043</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (Part A and Part B)</measure>
    <time_frame>Part A: 0 (pre-dose), 15 min, 60 min and 120 min post-dose Week 1, Week 2, Week 3, Week 4; Part B: Week 1, Week 4, Week 9, Week 13, Week 16, Week 28 and Week 52</time_frame>
    <description>To evaluate systemic and local PK of LNA043 following multiple i.a. injections of LNA043</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Articular cartilage bi-layer collagen organization evaluated with T2 relaxation times (in ms) (Part B only)</measure>
    <time_frame>Week 28, Week 52</time_frame>
    <description>To assess the extent of the repair cartilage tissue following multiple i.a. injections of LNA043</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>LNA043 40 mg Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LNA043 40 mg Part B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LNA043 20 mg Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LNA043 20 mg Part B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LNA043 20 mg Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LNA043 20 mg Part A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Part A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Part B</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LNA043</intervention_name>
    <description>LNA043 intra-articular injection</description>
    <arm_group_label>LNA043 20 mg Part A</arm_group_label>
    <arm_group_label>LNA043 20 mg Part B</arm_group_label>
    <arm_group_label>LNA043 40 mg Part B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo intra-articular injection</description>
    <arm_group_label>Placebo Part A</arm_group_label>
    <arm_group_label>Placebo Part B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria Part A&#xD;
&#xD;
          -  Patient is ≥18 and ≤55 years old at time of screening.&#xD;
&#xD;
          -  Patient has a body mass index (BMI) &lt;30 kg/m2 at screening, for patients with BMI &gt;30&#xD;
             but ≤ 33kg/m2, eligibility will be decided by consultation with the sponsor.&#xD;
&#xD;
          -  Patient has a symptomatic, single, articular cartilage defect of one knee, grade II or&#xD;
             IIIA according to the ICRS classification, localized to either the femoral&#xD;
             condyles/femoral trochlea or to the patella, based on MRI or arthroscopy performed&#xD;
             within 9 months before screening visit and confirmed by screening 3T MRI.&#xD;
&#xD;
          -  Patient has an onset of pain and impairment of function between two (2) months and two&#xD;
             (2) years before screening.&#xD;
&#xD;
          -  Patient reports a KOOS (sports and recreational activities subscale) score of ≤ 60 at&#xD;
             both screening and Day 1.&#xD;
&#xD;
        Inclusion criteria Part B&#xD;
&#xD;
          -  Patient is ≥18 and ≤75 years old at time of screening.&#xD;
&#xD;
          -  Patient has a body mass index (BMI) ≤ 35 kg/m2 at screening&#xD;
&#xD;
          -  Diagnosis of femorotibial osteoarthritis (OA) in the target knee by standard American&#xD;
             College of Rheumatology (ACR) criteria at study start (clinical AND radiographic&#xD;
             criteria)&#xD;
&#xD;
          -  Patient has a Kellgren &amp; Lawrence (K&amp;L) grade 2 or 3 OA of the knee with Joint Space&#xD;
             Width (JSW) 2-4 mm evaluated with X-Ray at screening.&#xD;
&#xD;
          -  Patient must have symptomatic disease predominantly in one (the index) knee, with&#xD;
             minimal or no symptoms in the contralateral knee. Symptomatic disease is defined as&#xD;
             having pain in the knee more than 50% of the days during the last 3 months from&#xD;
             screening.&#xD;
&#xD;
        Exclusion criteria Part A &amp; B&#xD;
&#xD;
          -  Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using highly effective methods of contraception&#xD;
             during dosing and for 15 days after stopping of investigational drug.&#xD;
&#xD;
          -  Patient has had surgical treatment of the target knee using mosaicplasty,&#xD;
             microfracture, meniscectomy &gt;50% (Note: prior diagnostic arthroscopy with debridement&#xD;
             and lavage, &lt;50% meniscectomy, lateral release, patellar realignment, medial&#xD;
             patellofemoral ligament reconstruction are acceptable if performed at least 2 months&#xD;
             prior to screening; anteriorcruciate ligament reconstrucion is acceptable if performed&#xD;
             12 months prior to screening, or less if restoration of joint function is evident, and&#xD;
             agreed by the sponsor).&#xD;
&#xD;
          -  Patient has an unstable target knee joint or insufficiently reconstructed ligaments&#xD;
             based on medical history and physical examination by the investigator.&#xD;
&#xD;
          -  Prohibited medication updated with reference to dosing (formerly screening).&#xD;
&#xD;
        Exclusion Criteria Part A only&#xD;
&#xD;
          -  Regular smokers (&gt; 5 cigarettes/day). Urine cotinine levels will be measured during&#xD;
             screening for all patients. Regular smokers will be defined as any patient who reports&#xD;
             tobacco use of &gt; 5 cigarettes/day and/or who has a urine cotinine ≥ 500 ng/mL.&#xD;
&#xD;
          -  Patient has radiologically apparent degenerative joint disease in the target knee as&#xD;
             determined by Kellgren and Lawrence grade ≥2 based on X-ray evaluation performed&#xD;
             within 9 months from screening.&#xD;
&#xD;
          -  Patient has patellofemoral dysplasia Dejour Grade B-D based on X-ray evaluation&#xD;
             performed within 9 months from screening&#xD;
&#xD;
          -  Patient has malalignment (valgus- or varus-deformity) in the target knee ≥ 5° based on&#xD;
             X-ray evaluation performed within 9 months from screening. In suspected cases, the&#xD;
             mechanical axis must be established radiographically through complete leg imaging&#xD;
             during standing and in postero-anterior (PA) projection.&#xD;
&#xD;
        Exclusion Criteria Part B only&#xD;
&#xD;
          -  Regular smokers (&gt; 10 cigarettes/day).&#xD;
&#xD;
          -  Clinical signs of inflammation (i.e., redness) in the target knee.&#xD;
&#xD;
          -  History of knee replacement (unilateral or total) in either knee.&#xD;
&#xD;
          -  Presence of severe hip OA conditioning lower limb function according to PI's&#xD;
             evaluation.&#xD;
&#xD;
          -  Nephrotic syndrome and/or significant proteinuria&#xD;
&#xD;
          -  History of coagulopathy or medical condition requiring anticoagulation which would&#xD;
             preclude knee injection&#xD;
&#xD;
          -  Patient has malalignment (valgus- or varus-deformity) in the target knee ≥ 7.5° based&#xD;
             on X-ray evaluation. In suspected cases, the mechanical axis must be established&#xD;
             radiographically through complete leg imaging during standing and in postero-anterior&#xD;
             (PA) projection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brno</city>
        <state>Czech Republic</state>
        <zip>66250</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mlada Boleslav</city>
        <state>Czech Republic</state>
        <zip>29301</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kladno</city>
        <zip>272 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kolin</city>
        <zip>280 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pardubice</city>
        <zip>53002</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aarhus C</city>
        <zip>DK 8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Sweden</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Articular cartilage</keyword>
  <keyword>partial thickness cartilage lesion</keyword>
  <keyword>knee cartilage</keyword>
  <keyword>regeneration</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>plaque-type psoriasis</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>Secukinumab</keyword>
  <keyword>lifestyle intervention</keyword>
  <keyword>systemic inflammation</keyword>
  <keyword>metabolism</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>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>September 4, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03275064
org study id: CLNA043X2202
secondary id: 2016-004052-30
secondary id: CTI-194705
nct id: NCT03275064
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this two-part study is to assess the efficacy, safety and tolerability of
      multiple intra-articular (i.a.) injections of LNA043 in regenerating the articular surface in
      patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B).
The purpose of this two-part study is to assess the efficacy, safety and tolerability of
      multiple intra-articular (i.a.) injections of LNA043 in regenerating the articular surface in
      patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B). In
      Part A, this study aims to establish Proof of Concept (PoC), namely regeneration of the
      articular cartilage, in order to provide information on the potential clinical utility of
      LNA043, with the ultimate goal of replacing current surgical procedures for cartilage repair
      with an injectable, less invasive regenerative therapy. In Part B, this study aims at further
      evaluating the cartilage anabolic activity of LNA043 in a more severe knee OA population, and
      at testing the potential benefit of a higher dose of LNA043 administered i.a. monthly instead
      of weekly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Articular cartilage bi-layer collagen organisation evaluated with MRI and measured in milliseconds (ms) (Part A only)
time frame: Up to Week 28
description: To assess the efficacy of multiple i.a. injections of LNA043 in regenerating the articular cartilage tissue
measure: Number of patients with any adverse events, serious adverse events and death (Part A and Part B)
time frame: Up to 52 weeks
description: To assess safety and local tolerability of multiple i.a. injections of LNA043
measure: Change in cartilage volume/thickness in the index region (Part B only)
time frame: Up to Week 52
description: To assess the efficacy of multiple i.a. injections of LNA043 in regenerating the articular cartilage tissue
measure: Change in volume of cartilage defect filling evaluated with MRI (Part A only)
time frame: Week 16, Week 28
description: To assess the extent of the repair cartilage tissue following multiple i.a. injections of LNA043
measure: Maximum Observed Plasma Concentration measured in ng/mL (Part A and Part B)
time frame: Part A: 0 (pre-dose), 15 min, 60 min and 120 min post-dose Week 1, Week 2, Week 3, Week 4; Part B: Week 1, Week 4, Week 9, Week 13, Week 16, Week 28 and Week 52
description: To evaluate systemic and local PK of LNA043 following multiple i.a. injections of LNA043
measure: Potential immunogenicity of LNA043 presence and characterisation of anti-LNA043 antibodies in serum (Part A and Part B)
time frame: Week 1, Week 3, Week 6, Week 16, Week 28
description: To assess the potential immunogenicity of LNA043
measure: Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (Part A and Part B)
time frame: Part A: 0 (pre-dose), 15 min, 60 min and 120 min post-dose Week 1, Week 2, Week 3, Week 4; Part B: Week 1, Week 4, Week 9, Week 13, Week 16, Week 28 and Week 52
description: To evaluate systemic and local PK of LNA043 following multiple i.a. injections of LNA043
measure: Articular cartilage bi-layer collagen organization evaluated with T2 relaxation times (in ms) (Part B only)
time frame: Week 28, Week 52
description: To assess the extent of the repair cartilage tissue following multiple i.a. injections of LNA043
arm group label: LNA043 40 mg Part B
arm group type: Experimental
description: LNA043 40 mg Part B
arm group label: LNA043 20 mg Part B
arm group type: Experimental
description: LNA043 20 mg Part B
arm group label: LNA043 20 mg Part A
arm group type: Experimental
description: LNA043 20 mg Part A
arm group label: Placebo Part A
arm group type: Placebo Comparator
description: Placebo Part A
arm group label: Placebo Part B
arm group type: Placebo Comparator
description: Placebo Part B
intervention type: Biological
intervention name: LNA043
description: LNA043 intra-articular injection
arm group label: LNA043 20 mg Part A
arm group label: LNA043 20 mg Part B
arm group label: LNA043 40 mg Part B
intervention type: Other
intervention name: Placebo
description: Placebo intra-articular injection
arm group label: Placebo Part A
arm group label: Placebo Part B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Czechia
country: Denmark
country: United States
country: Sweden
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
submitted: September 4, 2023