<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/NCT04496063</url>
  </required_header>
  <id_info>
    <org_study_id>GT-2019-01</org_study_id>
    <nct_id>NCT04496063</nct_id>
  </id_info>
  <brief_title>USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)</brief_title>
  <acronym>USTAP</acronym>
  <official_title>USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen, LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives</source>
  <oversight_info>
    <has_dmc>Yes</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 IV&#xD;
&#xD;
      Trial design : Multicentre, randomized, double-blind, placebo-controlled study&#xD;
&#xD;
      Population : Moderate to severe Crohn's disease with at least one active perianal fistula&#xD;
      track&#xD;
&#xD;
      Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg)&#xD;
      followed by UST SubCutaneous (SC) 90mg every 8 weeks. Group 2: Placebo IV followed by Placebo&#xD;
      SC The trial duration for each patient will be 48 weeks.&#xD;
&#xD;
      Trial objective : To evaluate the efficacy and safety of ustekinumab in fistulizing perianal&#xD;
      Crohn's disease.&#xD;
&#xD;
      Number of patients : A total of 146 patients will be included in 20 sites in France&#xD;
&#xD;
      Trial duration : First patient in: Q3 2020 - Last patient first visit: Q3 2022 Last patient&#xD;
      last visit: Q3 2023&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main endpoint:&#xD;
&#xD;
      The primary endpoint will be combined remission at week 12 defined as:&#xD;
&#xD;
        -  100% of the fistula tracts without any drainage by the external openings (occurring&#xD;
           spontaneously or after gentle finger compression) And&#xD;
&#xD;
        -  absence of collections &gt;2 cm of the treated perianal fistulas confirmed by masked&#xD;
           central MRI Patient requiring UST optimization will be considered in failure but will be&#xD;
           followed until week 48&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
      Definition&#xD;
&#xD;
        -  Clinical remission: 100% of the fistula tracts without any drainage by the external&#xD;
           openings (i.e, absence of any drainage by all fistula openings occurring spontaneously&#xD;
           or after gentle finger compression)&#xD;
&#xD;
        -  Clinical response (closure of at least 50% of all treated external openings that were&#xD;
           draining at baseline)&#xD;
&#xD;
        -  Radiological remission: absence of collections &gt;2 cm of the treated perianal fistulas&#xD;
           confirmed by masked central MRI&#xD;
&#xD;
        -  Combined clinical and radiological remission at week 24 and 48.&#xD;
&#xD;
        -  Clinical remission (i.e, absence of any drainage by all fistula openings occurring&#xD;
           spontaneously or after gentle finger compression) at week 12, 24 and 48&#xD;
&#xD;
        -  Absence of collections &gt;2 cm of the treated perianal fistulas confirmed by masked&#xD;
           central MRI at week 12, 24 and 48&#xD;
&#xD;
        -  Evaluation of the magnetic resonance novel index for fistula imaging in CD at week 12,&#xD;
           24 and 48&#xD;
&#xD;
        -  Clinical response (closure of at least 50% of all treated external openings that were&#xD;
           draining at baseline) at week 12, 24 and 48&#xD;
&#xD;
        -  Combined clinical response and radiological remission at week 48&#xD;
&#xD;
        -  Perineal Disease Activity Index (PDAI), Crohn Disease Activity Index (CDAI) at week 12,&#xD;
           24 and 48&#xD;
&#xD;
        -  Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire&#xD;
           (IBDQ) scores at week 24 and 48&#xD;
&#xD;
        -  Correlation between response and remission and UST trough levels and antidrug (UST)&#xD;
           antibodies at week 12, 24, 48&#xD;
&#xD;
        -  Clinical response of UST optimization at week 48 (closure of at least 50% of all treated&#xD;
           external openings that were draining at week 12)&#xD;
&#xD;
        -  Clinical response at week 48 of UST introduction at W12 (closure of at least 50% of all&#xD;
           treated external&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Anticipated">September 2, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2, 2023</primary_completion_date>
  <phase>Phase 4</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>Combined clinical and radiological remission</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of participants with 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression)&#xD;
- Number of participants with absence of collections &gt;2 cm of the treated perianal fistulas confirmed by masked central MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Combined clinical and radiological remission</measure>
    <time_frame>week 24 and week 48</time_frame>
    <description>Number of participants with 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression)&#xD;
- Number of participants with absence of collections &gt;2 cm of the treated perianal fistulas confirmed by masked central MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response</measure>
    <time_frame>week 12, week 24 and week 48</time_frame>
    <description>Number of participants with closure of at least 50% of all treated external openings that were draining at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MAGNIFI-CD26</measure>
    <time_frame>week 12, week 24 and week 48</time_frame>
    <description>Evaluation of the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD26)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PDAI</measure>
    <time_frame>week 12, week 24 and week 48</time_frame>
    <description>Perineal Disease Activity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBDQ scores</measure>
    <time_frame>week 24 and week 48</time_frame>
    <description>Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UST trough levels and antidrug</measure>
    <time_frame>week 12 and week 24</time_frame>
    <description>Correlation between response and remission and UST trough levels and antidrug (UST) antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response of UST optimization</measure>
    <time_frame>week 24 and week 48</time_frame>
    <description>Number of participants with closure of at least 50% of all treated external openings that were draining at week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response of UST introduction at week 12</measure>
    <time_frame>week 24 and week 48</time_frame>
    <description>Number of participants with closure of at least 50% of all treated external openings that were draining at week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CDAI</measure>
    <time_frame>week 12, week 24 and week 48</time_frame>
    <description>Crohn Disease Activity Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">146</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Group 1 Ustekinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo intravenous followed by Placebo subcutaneous every 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab</intervention_name>
    <description>Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks</description>
    <arm_group_label>Group 1 Ustekinumab</arm_group_label>
    <other_name>Stelara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo intravenous followed by Placebo subcutaneous every 8 weeks</description>
    <arm_group_label>Group 2 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Adults with moderate to severe Crohn's disease for at least six months&#xD;
&#xD;
          -  Patients with at least one active perianal fistula track (between the anus or low&#xD;
             rectum and the perineum or vulva) confirmed by MRI within the previous 12 weeks&#xD;
&#xD;
          -  Patients either naïve to anti-TNF therapy (50%) or refractory to anti-TNF therapy&#xD;
             (50%).&#xD;
&#xD;
          -  If female, subject is either not of child bearing potential, defined as&#xD;
             post-menopausal for at least1 year, surgically sterile (bilateral tubal ligation,&#xD;
             bilateral oophorectomy or hysterectomy), or is of childbearing potential and&#xD;
             practicing one of the following methods of birth control during the study and for 150&#xD;
             days after the last dose:&#xD;
&#xD;
               -  Condoms, sponge and foam, jellies with diaphragm or intrauterine device (IUD).&#xD;
                  IUDs may fail during azathioprine treatment. Alternative or additional&#xD;
                  contraceptive measures are advised, if azathioprine is initiated&#xD;
&#xD;
               -  Oral or parenteral contraceptives for 3 months prior to study drug administration&#xD;
&#xD;
               -  A vasectomized partner&#xD;
&#xD;
          -  Male subjects must agree to use an acceptable form of birth control, listed above at&#xD;
             the start of azathioprine administration and for 90 days after last dose of&#xD;
             azathioprine. Males should also commit to inform his partner(s) about it and to report&#xD;
             any pregnancy to the investigator.&#xD;
&#xD;
          -  If female, subject is not breast-feeding throughout the study and for 150 days after&#xD;
             last dose.&#xD;
&#xD;
          -  Subjects or his/her legal representative have voluntarily signed and dated an informed&#xD;
             consent approved by and compliant with the requirements of this study protocol which&#xD;
             has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee&#xD;
             (IEC)&#xD;
&#xD;
          -  Adequate cardiac, renal and hepatic function as determined by the Principal&#xD;
             Investigator and demonstrated by Screening laboratory evaluations, questionnaires and&#xD;
             physical examination results that do not indicate an abnormal clinical condition which&#xD;
             would place the subject at undue risk and thus preclude subject participation in the&#xD;
             study&#xD;
&#xD;
          -  Subject with a negative tuberculosis (TB) Screening Assessment [(including a Purified&#xD;
             Protein Derivative (PPD) test &lt; 5 mm and/or negative QuantiFERON-TB Gold test or&#xD;
             equivalent and negative Chest X-Ray (CXR) (PA and lateral view)] at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of written consent. People unable to give their consent (because of their&#xD;
             physical or mental state)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Rectovaginal fistulas&#xD;
&#xD;
          -  Rectal and/or anal stenosis&#xD;
&#xD;
          -  Diverting stomas&#xD;
&#xD;
          -  Abscess or collections &gt;2 cm which are not properly drained ((i.e not drained at least&#xD;
             3 weeks before baseline and adequately treated provided that there is no anticipated&#xD;
             need for any further surgery)&#xD;
&#xD;
          -  History of colectomy.&#xD;
&#xD;
          -  History of colonic mucosal dysplasia or adenomatous colonic polyps that are not&#xD;
             removed.&#xD;
&#xD;
          -  Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.&#xD;
             History of ongoing, chronic or recurrent infectious disease&#xD;
&#xD;
          -  Positive HIV, Hepatitis B Virus (HBV),Hepatitis C Virus (HCV)&#xD;
&#xD;
          -  Severe infection, chronic infection, history of recurrent infections, active infection&#xD;
             including TB&#xD;
&#xD;
          -  Malignancies or history of malignancies&#xD;
&#xD;
          -  History of congestive heart failure (NYHA: Grade III and IV), demyelinating disease,&#xD;
             current signs or history of severe/ progressive/uncontrolled renal, hepatic,&#xD;
             endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or&#xD;
             systemic lupus erythematosus (SLE).&#xD;
&#xD;
          -  History of transplanted organ, lymphoproliferative disease, any known malignancy&#xD;
&#xD;
          -  Previous allergy immunotherapy for anaphylaxis, hypersensitivity to ustekinumab or to&#xD;
             any excipients, or metronidazole or ciprofloxacin&#xD;
&#xD;
          -  Previous use of a biologic agent targeting Interleukin 12 (IL12) and/or Interleukin 23&#xD;
             (IL 23), including but not limited to ustekinumab&#xD;
&#xD;
          -  Oral corticosteroids at a dose &gt; 40 mg prednisone or its equivalent per day at&#xD;
             inclusion (oral steroids should be at stable dose at least 7 days before inclusion)&#xD;
&#xD;
          -  Any current or previous use of the following within 8 weeks before the first trial&#xD;
             agent injection : cyclosporine, tacrolimus, anti-TNF biologic agents or other agents&#xD;
             intended to suppress or eliminate Tumor Necrosing Factor (TNF), and other biologics,&#xD;
             including anti-integrin antibodies (approved or investigational), Janus Kinase (JAK)&#xD;
             inhibitors (approved or investigational), or any current or previous use of an&#xD;
             investigational agent&#xD;
&#xD;
          -  Non-autologous stem cell therapy or biologic agents that deplete B or T cells &lt;12&#xD;
             months prior to baseline&#xD;
&#xD;
          -  Current or recent (less than 4 weeks) vaccination with attenuated live vaccines&#xD;
&#xD;
          -  Patients using a prohibited medication&#xD;
&#xD;
          -  Patients participating in another trial or being in a follow-up period for another&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Benjamin PARIENTE, MD PhD</last_name>
    <phone>+ 33 20 44 47 97</phone>
    <email>Benjamin.PARIENTE@CHRU-LILLE.FR</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurent PEYRIN-BIROULET, MD PhD</last_name>
    <phone>+33 83 15 33 54</phone>
    <email>l.peyrinbiroulet@chru-nancy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <state>Bretagne</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Guillaume BOUGUEN, MD PhD</last_name>
      <phone>+33299284347</phone>
      <email>guillaume.bouguen@chu-rennes.fr</email>
    </contact>
    <investigator>
      <last_name>Guillaume BOUGUEN, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie DEWITTE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mathurin FUMERY</last_name>
      <email>Fumery.Mathurin@chu-amiens.fr</email>
    </contact>
    <investigator>
      <last_name>Mathurin FUMERY, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Besancon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lucine VUITTON</last_name>
    </contact>
    <contact_backup>
      <email>lvuitton@chu-besancon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Lucine VUITTON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anthony BUISSON</last_name>
      <email>a-buisson@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Anthony BUISSON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>APHP- Hopital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yoram BOUHNIK, MD</last_name>
      <email>yoram.bouhnik@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Yoram BOUHNIK, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Benoit COFFIN, MD PhD</last_name>
      <phone>+33 1 47 60 60 61</phone>
      <email>benoit.coffin@lmr.ap-hop-paris.fr</email>
    </contact>
    <investigator>
      <last_name>Benoit COFFIN, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Kremlin Bicêtre</name>
      <address>
        <city>Le Kremlin Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Franck CARBONNEL, MD PhD</last_name>
      <phone>+33 1 45 21 37 22</phone>
      <email>franck.carbonnel@bct.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Franck CARBONNEL, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin PARIENTE, MD, PhD</last_name>
      <email>Benjamin.PARIENTE@CHRU-LILLE.FR</email>
    </contact>
    <investigator>
      <last_name>Benjamin PARIENTE, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier - St Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Romain ALTWEGG, MD</last_name>
      <email>r-altwegg@chu-montpellier.fr</email>
    </contact>
    <investigator>
      <last_name>Romain ALTWEGG, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Arnaud BOUREILLE, MD PhD</last_name>
      <phone>+33 2 40 41 29 74</phone>
      <email>arnaud.boureille@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Arnaud BOUREILLE, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nice- Hopital l'Archet</name>
      <address>
        <city>Nice</city>
        <zip>62002</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xavier HEBUTERNE</last_name>
      <phone>+33 4 92 03 61 68</phone>
      <email>hebuterne.x@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Xavier HEBUTERNE, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nîmes - Hôpital Universitaire Caremeau</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludovic CAILLO, MD</last_name>
      <email>ludovic.caillo@chu-nimes.fr</email>
    </contact>
    <investigator>
      <last_name>Ludovic CAILLO, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital St Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Joëlle BONNET, MD</last_name>
      <email>joelle.bonnet@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Matthieu ALLEZ, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joëlle BONNET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe SEKSIK, MD PhD</last_name>
      <phone>+33 1 49 28 31 70</phone>
      <email>philippe.seksik@sat.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe SEKSIK, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne-Laure PELLETIER, MD</last_name>
      <email>anne-laure.pelletier@bch.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Anne-Laure PELLETIER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU LYON- Hopital Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane NANCEY, MD</last_name>
      <email>stephane.nancey@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Stéphane NANCEY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Roubaix</name>
      <address>
        <city>Roubaix</city>
        <zip>59056</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicolas DUVEAUX, MD</last_name>
      <phone>+33 3 20 99 32 01</phone>
      <email>nicolas.duveau@ch-roubaix.fr</email>
    </contact>
    <investigator>
      <last_name>Nicolas DUVEAUX, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier ROBLIN, MD PhD</last_name>
      <phone>+33 4 77 82 83 20</phone>
      <email>xavier.roblin@chu-st-etienne.fr</email>
    </contact>
    <investigator>
      <last_name>Xavier ROBLIN, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Tours - Hopital Trousseau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laurence PICON, MD</last_name>
      <email>l.picon@chu-tours.fr</email>
    </contact>
    <investigator>
      <last_name>Laurence PICON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nancy - Hôpital de Brabois</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent PEYRIN-BIROULET</last_name>
      <email>l.peyrinbiroulet@chru-nancy.fr</email>
    </contact>
    <investigator>
      <last_name>Laurent PEYRIN-BIROULET, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>Fistulising Perianal</keyword>
  <keyword>Placebo</keyword>
  <keyword>Ustekinumab</keyword>
  <keyword>Double-blind</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04496063
org study id: GT-2019-01
nct id: NCT04496063
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Phase IV

      Trial design : Multicentre, randomized, double-blind, placebo-controlled study

      Population : Moderate to severe Crohn's disease with at least one active perianal fistula
      track

      Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg)
      followed by UST SubCutaneous (SC) 90mg every 8 weeks. Group 2: Placebo IV followed by Placebo
      SC The trial duration for each patient will be 48 weeks.

      Trial objective : To evaluate the efficacy and safety of ustekinumab in fistulizing perianal
      Crohn's disease.

      Number of patients : A total of 146 patients will be included in 20 sites in France

      Trial duration : First patient in: Q3 2020 - Last patient first visit: Q3 2022 Last patient
      last visit: Q3 2023
Main endpoint:

      The primary endpoint will be combined remission at week 12 defined as:

        -  100% of the fistula tracts without any drainage by the external openings (occurring
           spontaneously or after gentle finger compression) And

        -  absence of collections >2 cm of the treated perianal fistulas confirmed by masked
           central MRI Patient requiring UST optimization will be considered in failure but will be
           followed until week 48

      Secondary endpoints:

      Definition

        -  Clinical remission: 100% of the fistula tracts without any drainage by the external
           openings (i.e, absence of any drainage by all fistula openings occurring spontaneously
           or after gentle finger compression)

        -  Clinical response (closure of at least 50% of all treated external openings that were
           draining at baseline)

        -  Radiological remission: absence of collections >2 cm of the treated perianal fistulas
           confirmed by masked central MRI

        -  Combined clinical and radiological remission at week 24 and 48.

        -  Clinical remission (i.e, absence of any drainage by all fistula openings occurring
           spontaneously or after gentle finger compression) at week 12, 24 and 48

        -  Absence of collections >2 cm of the treated perianal fistulas confirmed by masked
           central MRI at week 12, 24 and 48

        -  Evaluation of the magnetic resonance novel index for fistula imaging in CD at week 12,
           24 and 48

        -  Clinical response (closure of at least 50% of all treated external openings that were
           draining at baseline) at week 12, 24 and 48

        -  Combined clinical response and radiological remission at week 48

        -  Perineal Disease Activity Index (PDAI), Crohn Disease Activity Index (CDAI) at week 12,
           24 and 48

        -  Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire
           (IBDQ) scores at week 24 and 48

        -  Correlation between response and remission and UST trough levels and antidrug (UST)
           antibodies at week 12, 24, 48

        -  Clinical response of UST optimization at week 48 (closure of at least 50% of all treated
           external openings that were draining at week 12)

        -  Clinical response at week 48 of UST introduction at W12 (closure of at least 50% of all
           treated external
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Combined clinical and radiological remission
time frame: Week 12
description: Number of participants with 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression)
- Number of participants with absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI.
measure: Combined clinical and radiological remission
time frame: week 24 and week 48
description: Number of participants with 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression)
- Number of participants with absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI.
measure: Clinical response
time frame: week 12, week 24 and week 48
description: Number of participants with closure of at least 50% of all treated external openings that were draining at baseline
measure: MAGNIFI-CD26
time frame: week 12, week 24 and week 48
description: Evaluation of the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD26)
measure: PDAI
time frame: week 12, week 24 and week 48
description: Perineal Disease Activity Index
measure: IBDQ scores
time frame: week 24 and week 48
description: Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire scores
measure: UST trough levels and antidrug
time frame: week 12 and week 24
description: Correlation between response and remission and UST trough levels and antidrug (UST) antibodies
measure: Clinical response of UST optimization
time frame: week 24 and week 48
description: Number of participants with closure of at least 50% of all treated external openings that were draining at week 12
measure: Clinical response of UST introduction at week 12
time frame: week 24 and week 48
description: Number of participants with closure of at least 50% of all treated external openings that were draining at week 12
measure: CDAI
time frame: week 12, week 24 and week 48
description: Crohn Disease Activity Index
arm group label: Group 1 Ustekinumab
arm group type: Experimental
description: Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
arm group label: Group 2 Placebo
arm group type: Placebo Comparator
description: Placebo intravenous followed by Placebo subcutaneous every 8 weeks
intervention type: Drug
intervention name: Ustekinumab
description: Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
arm group label: Group 1 Ustekinumab
other name: Stelara
intervention type: Drug
intervention name: Placebo
description: Placebo intravenous followed by Placebo subcutaneous every 8 weeks
arm group label: Group 2 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin PARIENTE, MD PhD
phone: + 33 20 44 47 97
email: Benjamin.PARIENTE@CHRU-LILLE.FR
last name: Laurent PEYRIN-BIROULET, MD PhD
phone: +33 83 15 33 54
email: l.peyrinbiroulet@chru-nancy.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
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status: Not yet recruiting
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facility: 
status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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facility: 
status: Recruiting
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facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
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investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Not yet recruiting
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investigator: 
facility: 
status: Recruiting
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investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Ustekinumab