Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

Study Identifier
NX-13-1b
CT.gov Identifier
NCT04862741
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • NX-13 250mg IR
  • NX-13 500mg IR
  • NX-13 500mg MR
  • Placebo
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening; * active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader; * baseline fecal calprotectin ≥ 250 μg/g; * biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study; * 5-aminosalicylates must be stable for ≥ 1 month prior to randomization.
    Exclusion Criteria:
    * Crohn's disease (CD), indeterminate colitis, or presence or history of fistula with CD; * a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; * history of or at imminent risk of colectomy; * history of or current colonic dysplasia ; * recent history (within 2 years prior to randomization) or current adenomatous colonic polyps; * treatment with an immunosuppressant within 3 months of randomization; * bacterial or parasitic pathogenic enteric infection; * live virus vaccination within 1 month prior to screening.

    Protocol Summary

    This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

    Study Locations

    Location
    Status
    Location
    Avant Research Associates LLC
    Huntsville, Alabama, United States, 35802
    Status
    Not applicable
    Location
    Om Research LLC
    Lancaster, California, United States, 93534
    Status
    Not applicable
    Location
    Allameh Medical Corporation
    Mission Viejo, California, United States, 92691
    Status
    Not applicable
    Location
    California Medical Research Associates, Inc.
    Northridge, California, United States, 91324
    Status
    Not applicable
    Location
    Clinical Research of California
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
    Location
    I.H.S Health LLC
    Kissimmee, Florida, United States, 34741
    Status
    Not applicable
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