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/NCT06005532</url>
    </required_header>
    <id_info>
      <org_study_id>MABPS-3/2020</org_study_id>
      <nct_id>NCT06005532</nct_id>
    </id_info>
    <brief_title>Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®</brief_title>
    <official_title>Randomized Double Blind Phase III Trial Comparative Clinical Safety, Efficacy and Immunogenicity of Adalimumab (Manufactured by Mabscale, LLC) to Humira®.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mabscale, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mabscale, LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy,&#xD;
        immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to&#xD;
        Humira®.&#xD;
  &#xD;
        The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab&#xD;
        (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis&#xD;
        of moderate and severe degree.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adalimumab is a recombinant humanized monoclonal antibody currently being developed by&#xD;
        Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients&#xD;
        with chronic plaque psoriasis.&#xD;
  &#xD;
        This randomized equivalence study is designed to meet the regulatory requirement for approval&#xD;
        of a biosimilar product.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">March 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index)</measure>
      <time_frame>after 16 weeks of therapy (assessment at Visit 10)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients with positive antibody titer to Adalimumab</measure>
      <time_frame>51 weeks of therapy</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of patients who have neutralizing antibodies to Adalimumab</measure>
      <time_frame>51 weeks of therapy</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">494</enrollment>
    <condition>Plaque Psoriasis</condition>
    <arm_group>
      <arm_group_label>Adalimumab (manufactured by Mabscale, LLC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the main period, patients will begin Visit 1 receiving Adalimumab therapy at an initial dose (80 /0, 16 ml) on Visit 1, from Visit 2 Adalimumab therapy at a maintenance dose (40 /0, 8 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 8 ml)) every 2 weeks until the end of a trial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Humira®</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the main period, patients will begin Visit 1 receiving Humira® therapy at an initial dose (80 /0, 8 ml) on Visit 1, from Visit 2 Humira® therapy at a maintenance dose (40 /0, 4 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days.&#xD;
  In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 4 ml)) every 2 weeks until the end of a trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Adalimumab</intervention_name>
      <description>Adalimumab injection 40 mg / 0.8 ml</description>
      <arm_group_label>Adalimumab (manufactured by Mabscale, LLC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Humira</intervention_name>
      <description>Adalimumab injection 40 mg / 0.4 ml</description>
      <arm_group_label>Humira®</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent.&#xD;
  &#xD;
            2. Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.&#xD;
  &#xD;
            3. Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the&#xD;
               screening.&#xD;
  &#xD;
            4. Plaque psoriasis of moderate or severe severity of stable course with:&#xD;
  &#xD;
                 -  PASI ≥ 12 points;&#xD;
  &#xD;
                 -  BSA ≥ 10 %;&#xD;
  &#xD;
                 -  sPGA ≥ 3 points.&#xD;
  &#xD;
            5. Patients who have been shown to undergo systemic therapy and/or patients who have had&#xD;
               insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for&#xD;
               psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive&#xD;
               drugs, or who have had intolerance to standard systemic therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Data on intolerance or hypersensitivity to any components of the drugs, or to any&#xD;
               other human proteins, immunoglobulin preparations.&#xD;
  &#xD;
            2. A history of severe hypersensitivity reactions of any etiology.&#xD;
  &#xD;
            3. Other (other than plaque) forms of psoriasis.&#xD;
  &#xD;
            4. Drug-induced psoriasis.&#xD;
  &#xD;
            5. Data on the use of the Adalimumab or any preparations of monoclonal antibodies&#xD;
               inhibiting TNF-α at any time during life.&#xD;
  &#xD;
            6. The presence of Adalimumab antibodies.&#xD;
  &#xD;
            7. Extensive surgical intervention performed less than 30 days before the screening&#xD;
               period, or planned extensive surgical intervention during the study period.&#xD;
  &#xD;
            8. Active or latent tuberculosis&#xD;
  &#xD;
            9. Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a&#xD;
               history of multiple myeloma.&#xD;
  &#xD;
           10. Any other malignant neoplasms currently or in anamnesis within the last 5 years, with&#xD;
               the exception of completely removed and/or cured.&#xD;
  &#xD;
           11. Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the&#xD;
               screening period.&#xD;
  &#xD;
           12. Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C,&#xD;
               HIV.&#xD;
  &#xD;
           13. Vaccination with live or attenuated vaccines within 8 weeks before the screening&#xD;
               period.&#xD;
  &#xD;
           14. Hepatic and/or renal insufficiency.&#xD;
  &#xD;
           15. Pregnancy or lactation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yulia BASKAEVA</last_name>
      <phone>+74997149289</phone>
      <email>baskaeva.y@benerix.ru</email>
    </overall_contact>
    <location>
      <facility>
        <name>Regional dermatovenerologic dispensary</name>
        <address>
          <city>Barnaul</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Kovaleva</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chelyabinsk Regional Clinical Dermatovenerologic Dispensary</name>
        <address>
          <city>Chelyabinsk</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Ziganshin</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Interregional Clinical Diagnostic Center</name>
        <address>
          <city>Kazan'</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Isaeva</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>City clinical hospital n.a.Botkin</name>
        <address>
          <city>Moscow</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Sotnikova</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rheumatology research Instititue n.a.Nasonova</name>
        <address>
          <city>Moscow</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Korsakova</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>State Scientific Center of Dermatovenerology and Cosmetology</name>
        <address>
          <city>Nizhny Novgorod</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Gorodnichev</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Reafan</name>
        <address>
          <city>Novosibirsk</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Filippova</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>New Clinic</name>
        <address>
          <city>Pyatigorsk</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Chistyakova</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dermatovenerologic dispensary N10</name>
        <address>
          <city>Saint Petersburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <contact>
        <last_name>Sukharev</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psoriasis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adalimumab</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06005532
  org study id: MABPS-3/2020
  nct id: NCT06005532
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy,
        immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to
        Humira®.
  
        The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab
        (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis
        of moderate and severe degree.
  Adalimumab is a recombinant humanized monoclonal antibody currently being developed by
        Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients
        with chronic plaque psoriasis.
  
        This randomized equivalence study is designed to meet the regulatory requirement for approval
        of a biosimilar product.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index)
  time frame: after 16 weeks of therapy (assessment at Visit 10)
  measure: Proportion of patients with positive antibody titer to Adalimumab
  time frame: 51 weeks of therapy
  measure: Percentage of patients who have neutralizing antibodies to Adalimumab
  time frame: 51 weeks of therapy
  arm group label: Adalimumab (manufactured by Mabscale, LLC)
  arm group type: Experimental
  description: In the main period, patients will begin Visit 1 receiving Adalimumab therapy at an initial dose (80 /0, 16 ml) on Visit 1, from Visit 2 Adalimumab therapy at a maintenance dose (40 /0, 8 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 8 ml)) every 2 weeks until the end of a trial.
  arm group label: Humira®
  arm group type: Active Comparator
  description: In the main period, patients will begin Visit 1 receiving Humira® therapy at an initial dose (80 /0, 8 ml) on Visit 1, from Visit 2 Humira® therapy at a maintenance dose (40 /0, 4 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days.
  In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 4 ml)) every 2 weeks until the end of a trial.
  intervention type: Drug
  intervention name: Adalimumab
  description: Adalimumab injection 40 mg / 0.8 ml
  arm group label: Adalimumab (manufactured by Mabscale, LLC)
  intervention type: Drug
  intervention name: Humira
  description: Adalimumab injection 40 mg / 0.4 ml
  arm group label: Humira®
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Yulia BASKAEVA
  phone: +74997149289
  email: baskaeva.y@benerix.ru
  facility: 
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  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Psoriasis
  mesh term: Adalimumab