<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/NCT04457336</url>
  </required_header>
  <id_info>
    <org_study_id>SPR001-203</org_study_id>
    <secondary_id>CAHmelia 203</secondary_id>
    <nct_id>NCT04457336</nct_id>
  </id_info>
  <brief_title>A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects With Classic Congenital Adrenal Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spruce Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spruce Biosciences</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>
      An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont&#xD;
      in subjects with classic CAH who have elevated biomarkers at baseline on their current GC&#xD;
      regimen. Optional open label treatment extension period up to 240 weeks with 200mg&#xD;
      tildacerfont QD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study that will test the efficacy and safety of Tildacerfont. The first 12-weeks&#xD;
      will be a double-blind, placebo controlled, dose ranging study. The following 58-weeks will&#xD;
      assess the long term safety of Tildacerfont. Optional open label treatment extension period&#xD;
      up to 240 weeks with 200mg tildacerfont QD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <intervention_model_description>Subjects will be randomized in a 1:1:1:1 manner to one of three doses of Tildacerfont or Placebo.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in androstenedione</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent change of androstenedione</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve reduction A4 levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of subjects who achieve A4 ≤ ULN</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve reduction in 17-OHP</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of subjects who achieve 17-OHP≤ 1200ng/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness in reducing TART(s) in Male CAH subjects</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in lesion volume of TART(s) from baseline</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Congenital Adrenal Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Tildacerfont Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tildacerfont administered daily via oral tablet for 12 weeks at dose level 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tildacerfont Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tildacerfont administered daily via oral tablet for 12 weeks at dose level 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tildacerfont Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tildacerfont administered daily via oral tablet for 70 weeks at dose level 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered daily via oral tablet for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tildacerfont/Placebo</intervention_name>
    <description>Tablet, administered daily</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tildacerfont Group 1</arm_group_label>
    <arm_group_label>Tildacerfont Group 2</arm_group_label>
    <arm_group_label>Tildacerfont Group 3</arm_group_label>
    <other_name>SPR001</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects over 18 years old, inclusive&#xD;
&#xD;
          -  Has a known childhood diagnosis of classic CAH due to 21-hydroxylase deficiency based&#xD;
             on genetic mutation in CYP21A2 and/or documented elevated 17-OHP and currently treated&#xD;
             with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combination of&#xD;
             the aforementioned GCs)&#xD;
&#xD;
          -  Has been on a stable supraphysiologic dose of GC replacement ≥15 mg/day and ≤60 mg/day&#xD;
             in HC equivalents&#xD;
&#xD;
          -  For subjects with the salt-wasting form of CAH, subject has been on a stable dose of&#xD;
             mineralocorticoid replacement for ≥1 month before screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a known or suspected diagnosis of any other known form of classic CAH (not due to&#xD;
             21 hydroxylase deficiency)&#xD;
&#xD;
          -  Has a history that includes bilateral adrenalectomy or hypopituitarism&#xD;
&#xD;
          -  Has a history of allergy or hypersensitivity to Tildacerfont, any of its excipients,&#xD;
             or any other CRF1 receptor antagonist&#xD;
&#xD;
          -  Current treatment with dexamethasone as GC therapy for CAH. Prior treatment with&#xD;
             dexamethasone is allowed as long as the transition to an alternative GC regimen (eg,&#xD;
             HC, prednisone, or prednisolone) has resulted in a stable dose of GC replacement for&#xD;
             ≥1 month before screening.&#xD;
&#xD;
          -  Shows clinical signs or symptoms of adrenal insufficiency&#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_official>
    <last_name>Kyriakie Sarafoglou, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Pediatrics, Divisions of Endocrinology and Genetics &amp; Metabolism, Univ. of Minnesota</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clinical Trials</last_name>
    <phone>415-655-4169</phone>
    <email>CAHmelia@sprucebiosciences.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Jefferson</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Clinical Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce study site</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Elizabeth Vale</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Sydney</city>
        <zip>2006</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Sydney</city>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Ottawa</city>
        <zip>K1H7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Sherbrooke</city>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Kaunas</city>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Bucuresti</city>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Tarragona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Falun</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Saint Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spruce Study Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAH</keyword>
  <keyword>Adrenal Disorder</keyword>
  <keyword>Congenital Adrenal Hyperplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenal Hyperplasia, Congenital</mesh_term>
    <mesh_term>Adrenogenital Syndrome</mesh_term>
    <mesh_term>Adrenocortical Hyperfunction</mesh_term>
    <mesh_term>Hyperplasia</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/NCT04457336
org study id: SPR001-203
secondary id: CAHmelia 203
nct id: NCT04457336
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont
      in subjects with classic CAH who have elevated biomarkers at baseline on their current GC
      regimen. Optional open label treatment extension period up to 240 weeks with 200mg
      tildacerfont QD.
This is a study that will test the efficacy and safety of Tildacerfont. The first 12-weeks
      will be a double-blind, placebo controlled, dose ranging study. The following 58-weeks will
      assess the long term safety of Tildacerfont. Optional open label treatment extension period
      up to 240 weeks with 200mg tildacerfont QD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized in a 1:1:1:1 manner to one of three doses of Tildacerfont or Placebo.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double-Blind
measure: Change in androstenedione
time frame: 12 weeks
description: Percent change of androstenedione
measure: Proportion of subjects who achieve reduction A4 levels
time frame: 12 weeks
description: Proportion of subjects who achieve A4 ≤ ULN
measure: Proportion of subjects who achieve reduction in 17-OHP
time frame: 12 weeks
description: Proportion of subjects who achieve 17-OHP≤ 1200ng/dL
measure: Effectiveness in reducing TART(s) in Male CAH subjects
time frame: 12 weeks
description: Change in lesion volume of TART(s) from baseline
arm group label: Tildacerfont Group 1
arm group type: Experimental
description: Tildacerfont administered daily via oral tablet for 12 weeks at dose level 1
arm group label: Tildacerfont Group 2
arm group type: Experimental
description: Tildacerfont administered daily via oral tablet for 12 weeks at dose level 2
arm group label: Tildacerfont Group 3
arm group type: Experimental
description: Tildacerfont administered daily via oral tablet for 70 weeks at dose level 3
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered daily via oral tablet for 12 weeks.
intervention type: Drug
intervention name: Tildacerfont/Placebo
description: Tablet, administered daily
arm group label: Placebo
arm group label: Tildacerfont Group 1
arm group label: Tildacerfont Group 2
arm group label: Tildacerfont Group 3
other name: SPR001
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyriakie Sarafoglou, M.D
role: Principal Investigator
affiliation: Dept. of Pediatrics, Divisions of Endocrinology and Genetics & Metabolism, Univ. of Minnesota
last name: Clinical Trials
phone: 415-655-4169
email: CAHmelia@sprucebiosciences.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Canada
country: Denmark
country: Estonia
country: Germany
country: Italy
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Netherlands
country: Poland
country: Romania
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Adrenal Hyperplasia, Congenital
mesh term: Adrenogenital Syndrome
mesh term: Adrenocortical Hyperfunction
mesh term: Hyperplasia
sharing ipd: No