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      "canonicalId": "NCT05287126",
      "title": "A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis",
      "scientificTitle": "An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis",
      "status": "recruiting",
      "studyType": "interventional",
      "phase": [
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      "conditions": [
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      "interventions": [
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          "name": "Etrasimod",
          "type": "DRUG",
          "description": "Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment."
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      "sponsor": {
        "name": "Pfizer",
        "type": "INDUSTRY"
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      "locations": [
        {
          "city": "Little Rock",
          "country": "United States",
          "facility": "Arkansas Children's (IP Address)"
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        {
          "city": "Little Rock",
          "country": "United States",
          "facility": "Arkansas Children's"
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        {
          "city": "Garden Grove",
          "country": "United States",
          "facility": "Valley View Wellness Medical Center"
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        {
          "city": "Loma Linda",
          "country": "United States",
          "facility": "Loma Linda Children's Hospital"
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        {
          "city": "Loma Linda",
          "country": "United States",
          "facility": "Loma Linda University Clinical Trial Center"
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        {
          "city": "Loma Linda",
          "country": "United States",
          "facility": "Loma Linda University Eye Institute"
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        {
          "city": "Loma Linda",
          "country": "United States",
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        {
          "city": "Loma Linda",
          "country": "United States",
          "facility": "Loma Linda University Pediatric Clinics"
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        {
          "city": "San Bernardino",
          "country": "United States",
          "facility": "Loma Linda University Children's Hospital Pediatric Specialty Clinics"
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        {
          "city": "San Francisco",
          "country": "United States",
          "facility": "University of California San Francisco,"
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        {
          "city": "San Francisco",
          "country": "United States",
          "facility": "University of California San Francisco"
        },
        {
          "city": "San Francisco",
          "country": "United States",
          "facility": "University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)"
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        {
          "city": "Orlando",
          "country": "United States",
          "facility": "Arnold Palmer Hospital - Center for Digestive Health and Nutrition"
        },
        {
          "city": "Chicago",
          "country": "United States",
          "facility": "University of Chicago Medical Center"
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        {
          "city": "Boston",
          "country": "United States",
          "facility": "Boston Children's Hospital"
        },
        {
          "city": "Royal Oak",
          "country": "United States",
          "facility": "William Beaumont Hospital/Corewell Health - East"
        },
        {
          "city": "Royal Oak",
          "country": "United States",
          "facility": "William Beaumont Hospitals Reference Laboratory"
        },
        {
          "city": "Cleveland",
          "country": "United States",
          "facility": "University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital"
        },
        {
          "city": "Cleveland",
          "country": "United States",
          "facility": "University Hospitals Cleveland Medical Center"
        },
        {
          "city": "Abilene",
          "country": "United States",
          "facility": "ACT-Midwest G1"
        },
        {
          "city": "Fort Worth",
          "country": "United States",
          "facility": "Cook Children's Health Care System-Dodson Specialty Clinics"
        },
        {
          "city": "Fort Worth",
          "country": "United States",
          "facility": "Cook Children's Medical Center"
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        {
          "city": "Kashiwa",
          "country": "Japan",
          "facility": "Tsujinaka Hospital - Kashiwanoha"
        },
        {
          "city": "Nagareyama-shi",
          "country": "Japan",
          "facility": "Ishii Eye Clinic"
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        {
          "city": "Maebashi",
          "country": "Japan",
          "facility": "Gunma University Hospital"
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        {
          "city": "Nishinomiya",
          "country": "Japan",
          "facility": "Hyogo Medical University Hospital"
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        {
          "city": "Ikoma",
          "country": "Japan",
          "facility": "Kinki University - Nara Hospital"
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          "city": "Saitama-shi",
          "country": "Japan",
          "facility": "Saitama Prefectural Children's Medical Center"
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        {
          "city": "Shimotsuke",
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          "facility": "Jichi Medical University Hospital"
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        {
          "city": "Bunkyo-ku",
          "country": "Japan",
          "facility": "Juntendo University Hospital"
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        {
          "city": "Kyoto",
          "country": "Japan",
          "facility": "Japanese Red Cross Kyoto Daini Hospital"
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        {
          "city": "Saga",
          "country": "Japan",
          "facility": "Saga University Hospital"
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        {
          "city": "Toyama",
          "country": "Japan",
          "facility": "Toyama Prefectural Central Hospital"
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          "city": "Warsaw",
          "country": "Poland",
          "facility": "WIP Warsaw IBD Point Profesor Kierkuś"
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          "city": "Warsaw",
          "country": "Poland",
          "facility": "Instytut \"Pomnik - Centrum Zdrowia Dziecka\" (IPCZD) (The Children's Memorial Health Institute)"
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          "city": "Katowice",
          "country": "Poland",
          "facility": "Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero"
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        {
          "city": "Krakow",
          "country": "Poland",
          "facility": "Uniwersytecki Szpital Dziecięcy w Krakowie"
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          "city": "Szczecin",
          "country": "Poland",
          "facility": "Twoja Przychodnia - Szczecińskie Centrum Medyczne"
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        {
          "city": "Warsaw",
          "country": "Poland",
          "facility": "Centrum Zdrowia MDM"
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        {
          "city": "Warsaw",
          "country": "Poland",
          "facility": "WIP Warsaw IBD Point Profesor Kierkus"
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        {
          "city": "Wroclaw",
          "country": "Poland",
          "facility": "Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu"
        },
        {
          "city": "Košice",
          "country": "Slovakia",
          "facility": "Detska fakultna nemocnica Kosice"
        },
        {
          "city": "Nitra",
          "country": "Slovakia",
          "facility": "K.M. Management, spol. s r.o."
        },
        {
          "city": "Santiago de Compostela",
          "country": "Spain",
          "facility": "Hospital Clinico Universitario de Santiago de Compostela"
        },
        {
          "city": "Sabadell",
          "country": "Spain",
          "facility": "Consorci Corporacio Sanitaria Parc Tauli"
        },
        {
          "city": "Barcelona",
          "country": "Spain",
          "facility": "Hospital Universitari Vall d'Hebron"
        },
        {
          "city": "Córdoba",
          "country": "Spain",
          "facility": "Hospital Reina Sofia"
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        "primary": [
          "Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52"
        ],
        "secondary": [
          "Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)",
          "Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod",
          "Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12",
          "Proportion of Participants Achieving Endoscopic Improvement at Week 12",
          "Proportion of Participants Achieving Endoscopic Improvement at Week 52",
          "Proportion of Participants Achieving Symptomatic Remission at Week 12",
          "Proportion of Participants Achieving Symptomatic Remission at Week 52",
          "Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12",
          "Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52",
          "Proportion of Participants Achieving Clinical Response at Week 12",
          "Proportion of Participants Achieving Clinical Response at Week 52",
          "Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12",
          "Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52",
          "Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12",
          "Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52",
          "Number and Severity of Adverse Events"
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        "criteria": "Inclusion criteria:\n\n* Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active\n* Participants are permitted to be receiving a therapeutic dose of select UC therapies\n\nExclusion criteria:\n\n* Severe extensive colitis\n* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD\n* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis",
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      "startDate": "2022-12-16",
      "completionDate": "2033-07-10",
      "lastUpdated": "2026-10-27T00:00:00.000Z",
      "firstPosted": "2022-03-18T00:00:00.000Z",
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