<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/NCT03768219</url>
  </required_header>
  <id_info>
    <org_study_id>8001</org_study_id>
    <nct_id>NCT03768219</nct_id>
  </id_info>
  <brief_title>Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis</brief_title>
  <official_title>Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aptevo Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aptevo Therapeutics</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>
      Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending&#xD;
      dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending&#xD;
      dose (MAD) study of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple&#xD;
      doses of APVO210 in psoriasis patients and ulcerative colitis patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business decision&#xD;
  </why_stopped>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>SAD: Randomized, double-blind, placebo-controlled, sequential cohort-group study with a sentinel subject design&#xD;
MAD: Randomized, double-blind, placebo-controlled, sequential cohort-group study&#xD;
Psoriasis Expansion Cohort: Randomized, double-blind, placebo-controlled study&#xD;
Ulcerative Colitis Expansion Cohort: Randomized, double-blind, placebo-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in vital signs</measure>
    <time_frame>up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with significant changes from baseline laboratory measurements</measure>
    <time_frame>up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results</measure>
    <time_frame>up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical significant abnormalities found on physical examination</measure>
    <time_frame>up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in vital signs</measure>
    <time_frame>up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with significant changes from baseline laboratory measurements</measure>
    <time_frame>up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results</measure>
    <time_frame>up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical significant abnormalities found on physical examination</measure>
    <time_frame>up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of psoriasis patients with adverse events</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of psoriasis patients with clinically relevant findings in vital signs</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of psoriasis patients with significant changes from baseline laboratory measurements</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of psoriasis patients with clinical significant abnormalities found on physical examination</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ulcerative colitis patients with adverse events</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ulcerative colitis patients with clinically relevant findings in vital signs</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ulcerative colitis patients with significant changes from baseline laboratory measurements</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination</measure>
    <time_frame>up to day 141</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of subjects who develop anti-drug antibodies to APVO210</measure>
    <time_frame>Up to day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects who develop anti-drug antibodies to APVO210</measure>
    <time_frame>Up to day 57</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of psoriasis patients who develop anti-drug antibodies to APVO210</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of Peak Plasma Concentration (Cmax)</measure>
    <time_frame>Up to day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of Peak Plasma Concentration (Cmax)</measure>
    <time_frame>Up to day 57</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>Up to day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>Up to day 57</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) for psoriasis patients</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of leukocytes by flow cytometry in psoriasis patients</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of leukocytes by flow cytometry in ulcerative colitis patients</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.</measure>
    <time_frame>Up to day 141</time_frame>
  </secondary_outcome>
  <number_of_arms>14</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Psoriasis</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 2 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 5 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 10 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 20 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 (SAD) Cohort 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 subjects will receive 320 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 (MAD) Cohort 9</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 (MAD) Cohort 10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 (MAD) Cohort 11</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 (MAD) Cohort 12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 subjects will receive 360 mcg/kg of APVO210 2 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Cohort (Psoriasis)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 subjects will receive the starting dose for the Psoriasis Patients Expansion Cohort portion of the study will be the recommended dose from Stage 2 of the study of APVO210. It will be a dose that has been demonstrated to be safe and well tolerated by the Safety Monitoring Committee.&#xD;
8 subjects will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Cohort (Ulcerative Colitis)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 Subjects will receive the starting dose for the Ulcerative Colitis Patients Expansion Cohort portion of the study will be the recommended dose from Stage 2 of the study of APVO210. It will be a dose that has been demonstrated to be safe and well tolerated by the Safety Monitoring Committee.&#xD;
8 subjects will receive placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>APVO210</intervention_name>
    <description>APVO210</description>
    <arm_group_label>Expansion Cohort (Psoriasis)</arm_group_label>
    <arm_group_label>Expansion Cohort (Ulcerative Colitis)</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 1</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 2</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 3</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 4</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 5</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 6</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 7</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 8</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 10</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 11</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 12</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is saline based IV infusion, and is identical in appearance to active study drug.</description>
    <arm_group_label>Expansion Cohort (Psoriasis)</arm_group_label>
    <arm_group_label>Expansion Cohort (Ulcerative Colitis)</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 1</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 2</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 3</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 4</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 5</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 6</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 7</arm_group_label>
    <arm_group_label>Stage 1 (SAD) Cohort 8</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 10</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 11</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 12</arm_group_label>
    <arm_group_label>Stage 2 (MAD) Cohort 9</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 65 years old.&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 18.5 kg/m2 and &lt; 30.0 kg/m2; minimum body weight of 50 kg.&#xD;
&#xD;
          -  Good health and no clinically significant findings on:&#xD;
&#xD;
          -  Physical examination&#xD;
&#xD;
          -  12-lead ECG&#xD;
&#xD;
          -  Clinical laboratory tests (serum chemistry, haematology, coagulation, urine drug&#xD;
             screen, and urinalysis (UA))&#xD;
&#xD;
          -  Seated systolic blood pressure (BP) 90 to 140 mm Hg.&#xD;
&#xD;
          -  Seated diastolic BP 60 to 90 mm Hg.&#xD;
&#xD;
        Psoriasis Patients (Expansion Cohort):&#xD;
&#xD;
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of chronic plaque psoriasis with a disease duration of at least 6&#xD;
             months; patients with concurrent psoriatic arthritis may be enrolled.&#xD;
&#xD;
          -  Psoriasis Area and Severity Index (PASI) score ≥ 12 at baseline.&#xD;
&#xD;
          -  Psoriasis plaque BSA (Body surface area) ≥ 10%&#xD;
&#xD;
          -  PGA (Physician Global Assessment) ≥ 3.&#xD;
&#xD;
          -  Age 18 to 65 years old.&#xD;
&#xD;
          -  Body mass index &gt; 18.5 and &lt; 35.0 kg/m2; minimum body weight of 50 kg.&#xD;
&#xD;
        Ulcerative Colitis Patients (Expansion Cohort):&#xD;
&#xD;
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Moderately to severely active ulcerative colitis as defined by:&#xD;
&#xD;
          -  Baseline Mayo Score of 6 to 12; and&#xD;
&#xD;
          -  Endoscopic sub-score ≥2 as read by central reader&#xD;
&#xD;
          -  Is intolerant, refractory, or only partially responsive to corticosteroids (not&#xD;
             including budesonide), immunomodulators (azathioprine [AZA] or 6-mercaptopurine&#xD;
             [6-MP], and methotrexate), or biologics.&#xD;
&#xD;
          -  Age 18 to 65 years old.&#xD;
&#xD;
          -  Body mass index &gt; 18.5 and &lt; 35.0 kg/m2; minimum body weight of 50 kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Main Exclusion Criteria&#xD;
&#xD;
          -  Clinically significant manifestation of metabolic; hepatic; renal; haematological;&#xD;
             pulmonary; cardiovascular; gastrointestinal; musculoskeletal; dermatological;&#xD;
             urogenital; eye, ear, nose, and throat; psychiatric; or neurological disorders.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 1.2 times the&#xD;
             upper limit of normal (ULN) as defined by the laboratory.&#xD;
&#xD;
          -  Positive hepatitis panel (hepatitis B surface antigen [HBsAg] and anti-hepatitis C&#xD;
             virus [HCV]) or positive human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Positive Quantiferon tuberculosis (TB) test at Screening Visit.&#xD;
&#xD;
          -  Receipt of live vaccine less than 1 month prior to Check in or plan to receive live&#xD;
             vaccine during the study or up to 3 months following End of Treatment visit.&#xD;
&#xD;
          -  Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral&#xD;
             antibiotics.&#xD;
&#xD;
        Psoriasis Patients (Expansion Cohort):&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  History of malignancy, diagnosed or known to be active or actively treated within the&#xD;
             past 5 years, other than resected lesions of low malignant potential, such as basal&#xD;
             cell skin cancers or low risk squamous cell carcinomas of the skin.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 2 times the upper&#xD;
             limit of normal (ULN) as defined by the laboratory.&#xD;
&#xD;
          -  Creatinine &gt; 1.5 times ULN as defined by the laboratory.&#xD;
&#xD;
          -  Positive hepatitis panel (hepatitis B surface antigen [HBsAg] and anti-hepatitis C&#xD;
             virus [HCV]) or positive human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Positive Quantiferon tuberculosis (TB) test at Screening Visit.&#xD;
&#xD;
          -  Receipt of live vaccine less than 1 month prior to Check in or plan to receive live&#xD;
             vaccine during the study or up to 3 months following End of Treatment visit.&#xD;
&#xD;
          -  Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral&#xD;
             antibiotics.&#xD;
&#xD;
          -  Use of a prescription medication that could have an effect on psoriasis (eg, lithium,&#xD;
             systemic steroids, immunosuppressants) during the 14 days before Check-in; use of&#xD;
             prescription medications for psoriasis is not permitted until after the Follow-up&#xD;
             Visit.&#xD;
&#xD;
          -  Non plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).&#xD;
&#xD;
          -  Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab,&#xD;
             ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and&#xD;
             ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB)&#xD;
             phototherapy, use of tanning beds, or use of systemic medications such as&#xD;
             methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks&#xD;
             prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2&#xD;
             weeks prior to Check-in.&#xD;
&#xD;
        Ulcerative Colitis Patients (Expansion Cohort):&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Ulcerative colitis requiring immediate surgical, endoscopic, or radiological&#xD;
             intervention including massive haemorrhage, perforation and sepsis, suppurative&#xD;
             complications, or toxic colon.&#xD;
&#xD;
          -  Stool positive for Clostridium difficile toxin, enteric pathogens, or ova and&#xD;
             parasites.&#xD;
&#xD;
          -  Positive hepatitis panel (hepatitis B surface antigen [HBsAg] and anti hepatitis C&#xD;
             virus [HCV]) or positive human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Positive Quantiferon tuberculosis (TB) test at Screening Visit.&#xD;
&#xD;
          -  Receipt of live vaccine less than 1 month prior to Check in or plan to receive live&#xD;
             vaccine during the study or up to 3 months following End of Treatment visit.&#xD;
&#xD;
          -  Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral&#xD;
             antibiotics.&#xD;
&#xD;
          -  Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab,&#xD;
             ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and&#xD;
             ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB)&#xD;
             phototherapy, use of tanning beds, or use of systemic medications such as&#xD;
             methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks&#xD;
             prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2&#xD;
             weeks prior to Check-in.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Schaaf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aptevo Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>May 15, 2021</last_update_submitted>
  <last_update_submitted_qc>May 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03768219
org study id: 8001
nct id: NCT03768219
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phase 1 study in 2 stages with 2 expansion cohorts. The first stage is a single ascending
      dose (SAD) study of APVO210 in healthy volunteers. The second stage is a multiple ascending
      dose (MAD) study of APVO210 in healthy volunteers. Two expansion cohorts evaluate multiple
      doses of APVO210 in psoriasis patients and ulcerative colitis patients.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: SAD: Randomized, double-blind, placebo-controlled, sequential cohort-group study with a sentinel subject design
MAD: Randomized, double-blind, placebo-controlled, sequential cohort-group study
Psoriasis Expansion Cohort: Randomized, double-blind, placebo-controlled study
Ulcerative Colitis Expansion Cohort: Randomized, double-blind, placebo-controlled study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with adverse events
time frame: up to Day 29
measure: Number of subjects with clinically relevant findings in vital signs
time frame: up to Day 29
measure: Number of subjects with significant changes from baseline laboratory measurements
time frame: up to Day 29
measure: Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
time frame: up to Day 29
measure: Number of subjects with clinical significant abnormalities found on physical examination
time frame: up to Day 29
measure: Number of subjects with adverse events
time frame: up to Day 57
measure: Number of subjects with clinically relevant findings in vital signs
time frame: up to Day 57
measure: Number of subjects with significant changes from baseline laboratory measurements
time frame: up to Day 57
measure: Number of subjects with clinically significant abnormalities in electrocardiogram (ECG) results
time frame: up to Day 57
measure: Number of subjects with clinical significant abnormalities found on physical examination
time frame: up to Day 57
measure: Number of psoriasis patients with adverse events
time frame: up to day 141
measure: Number of psoriasis patients with clinically relevant findings in vital signs
time frame: up to day 141
measure: Number of psoriasis patients with significant changes from baseline laboratory measurements
time frame: up to day 141
measure: Number of psoriasis patients with clinically significant abnormalities in electrocardiogram (ECG) results
time frame: up to day 141
measure: Number of psoriasis patients with clinical significant abnormalities found on physical examination
time frame: up to day 141
measure: Number of ulcerative colitis patients with adverse events
time frame: up to day 141
measure: Number of ulcerative colitis patients with clinically relevant findings in vital signs
time frame: up to day 141
measure: Number of ulcerative colitis patients with significant changes from baseline laboratory measurements
time frame: up to day 141
measure: Number of ulcerative colitis patients with clinically significant abnormalities in electrocardiogram (ECG) results
time frame: up to day 141
measure: Number of ulcerative colitis patients with clinical significant abnormalities found on physical examination
time frame: up to day 141
measure: The number of subjects who develop anti-drug antibodies to APVO210
time frame: Up to day 29
measure: The number of subjects who develop anti-drug antibodies to APVO210
time frame: Up to day 57
measure: The number of psoriasis patients who develop anti-drug antibodies to APVO210
time frame: Up to day 141
measure: The number of ulcerative colitis patients who develop anti-drug antibodies to APVO210
time frame: Up to day 141
measure: Serum level of Peak Plasma Concentration (Cmax)
time frame: Up to day 29
measure: Serum level of Peak Plasma Concentration (Cmax)
time frame: Up to day 57
measure: Serum level of Peak Plasma Concentration (Cmax) in psoriasis patients
time frame: Up to day 141
measure: Serum level of Peak Plasma Concentration (Cmax) in ulcerative colitis patients
time frame: Up to day 141
measure: Area under the plasma concentration versus time curve (AUC)
time frame: Up to day 29
measure: Area under the plasma concentration versus time curve (AUC)
time frame: Up to day 57
measure: Area under the plasma concentration versus time curve (AUC) for psoriasis patients
time frame: Up to day 141
measure: Area under the plasma concentration versus time curve (AUC) for ulcerative colitis patients
time frame: Up to day 141
measure: Change in number of leukocytes by flow cytometry in psoriasis patients
time frame: Up to day 141
measure: Change in number of leukocytes by flow cytometry in ulcerative colitis patients
time frame: Up to day 141
measure: Change in cytokine levels by ex-vivo LPS stimulation assay in psoriasis patients.
time frame: Up to day 141
measure: Change in cytokine levels by ex-vivo LPS stimulation assay in ulcerative colitis patients.
time frame: Up to day 141
arm group label: Stage 1 (SAD) Cohort 1
arm group type: Experimental
description: 6 subjects will receive 2 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 2
arm group type: Experimental
description: 6 subjects will receive 5 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 3
arm group type: Experimental
description: 6 subjects will receive 10 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 4
arm group type: Experimental
description: 6 subjects will receive 20 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 5
arm group type: Experimental
description: 6 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 6
arm group type: Experimental
description: 6 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 7
arm group type: Experimental
description: 6 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 1 (SAD) Cohort 8
arm group type: Experimental
description: 6 subjects will receive 320 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 2 (MAD) Cohort 9
arm group type: Experimental
description: 8 subjects will receive 40 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 2 (MAD) Cohort 10
arm group type: Experimental
description: 8 subjects will receive 80 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 2 (MAD) Cohort 11
arm group type: Experimental
description: 8 subjects will receive 160 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Stage 2 (MAD) Cohort 12
arm group type: Experimental
description: 8 subjects will receive 360 mcg/kg of APVO210 2 subjects will receive placebo
arm group label: Expansion Cohort (Psoriasis)
arm group type: Experimental
description: 12 subjects will receive the starting dose for the Psoriasis Patients Expansion Cohort portion of the study will be the recommended dose from Stage 2 of the study of APVO210. It will be a dose that has been demonstrated to be safe and well tolerated by the Safety Monitoring Committee.
8 subjects will receive placebo
arm group label: Expansion Cohort (Ulcerative Colitis)
arm group type: Experimental
description: 12 Subjects will receive the starting dose for the Ulcerative Colitis Patients Expansion Cohort portion of the study will be the recommended dose from Stage 2 of the study of APVO210. It will be a dose that has been demonstrated to be safe and well tolerated by the Safety Monitoring Committee.
8 subjects will receive placebo
intervention type: Biological
intervention name: APVO210
description: APVO210
arm group label: Expansion Cohort (Psoriasis)
arm group label: Expansion Cohort (Ulcerative Colitis)
arm group label: Stage 1 (SAD) Cohort 1
arm group label: Stage 1 (SAD) Cohort 2
arm group label: Stage 1 (SAD) Cohort 3
arm group label: Stage 1 (SAD) Cohort 4
arm group label: Stage 1 (SAD) Cohort 5
arm group label: Stage 1 (SAD) Cohort 6
arm group label: Stage 1 (SAD) Cohort 7
arm group label: Stage 1 (SAD) Cohort 8
arm group label: Stage 2 (MAD) Cohort 10
arm group label: Stage 2 (MAD) Cohort 11
arm group label: Stage 2 (MAD) Cohort 12
arm group label: Stage 2 (MAD) Cohort 9
intervention type: Biological
intervention name: Placebo
description: Placebo is saline based IV infusion, and is identical in appearance to active study drug.
arm group label: Expansion Cohort (Psoriasis)
arm group label: Expansion Cohort (Ulcerative Colitis)
arm group label: Stage 1 (SAD) Cohort 1
arm group label: Stage 1 (SAD) Cohort 2
arm group label: Stage 1 (SAD) Cohort 3
arm group label: Stage 1 (SAD) Cohort 4
arm group label: Stage 1 (SAD) Cohort 5
arm group label: Stage 1 (SAD) Cohort 6
arm group label: Stage 1 (SAD) Cohort 7
arm group label: Stage 1 (SAD) Cohort 8
arm group label: Stage 2 (MAD) Cohort 10
arm group label: Stage 2 (MAD) Cohort 11
arm group label: Stage 2 (MAD) Cohort 12
arm group label: Stage 2 (MAD) Cohort 9
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Schaaf, MD
role: Principal Investigator
affiliation: Aptevo Therapeutics
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Psoriasis
mesh term: Ulcer
sharing ipd: No