Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis

Last updated: January 5, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

2

Condition

Colic

Ulcers

Ulcerative Colitis

Treatment

NX-13 250mg

NX-13 750mg

NX-13 Placebo

Clinical Study ID

NCT05785715
NX-13-201
  • Ages 18-75
  • All Genders

Study Summary

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult subjects aged 18 to 75 years (inclusive)

  • Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence

  • Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline

  • ES ≥ 2 within 14 days prior to randomization

  • RBS ≥ 1.

Exclusion

Exclusion Criteria:

  • Severe extensive colitis as evidenced by physician judgment that the participant islikely to require hospitalization for medical care or surgical intervention of anykind for UC (e.g., colectomy) within the 12 weeks after randomization;

  • Current evidence of fulminant colitis, toxic megacolon or recent history (within 6months prior to screening) of toxic megacolon, or bowel perforation

  • Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence orhistory of a fistula consistent with CD

  • Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis

  • Bacterial or parasitic pathogenic enteric infection;

Study Design

Total Participants: 80
Treatment Group(s): 3
Primary Treatment: NX-13 250mg
Phase: 2
Study Start date:
April 24, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This is a randomized, multicenter, double-blind, placebo-controlled, multiple dose exploratory Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Connect with a study center

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven,
    Belgium

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

    Milan,
    Italy

    Site Not Available

  • Azienda Ospedaliera - Universitaria Sant' Andrea

    Roma,
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Rome,
    Italy

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

    Rozzano,
    Italy

    Site Not Available

  • IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino,
    Italy

    Site Not Available

  • ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy

    Bydgoszcz,
    Poland

    Site Not Available

  • Przychodnia Vitamed NFZ

    Bydgoszcz,
    Poland

    Site Not Available

  • AmiCare Centrum Medyczne

    Jelenia Gora,
    Poland

    Site Not Available

  • VITA LONGA Clinic - Katowice

    Katowice,
    Poland

    Site Not Available

  • Krakowska Przychodnia FutureMeds

    Kraków,
    Poland

    Site Not Available

  • AmiCare Sp. z o.o. Sp.k.

    Lodz,
    Poland

    Site Not Available

  • Uniwersytet Medyczny w Łodzi

    Lodz,
    Poland

    Active - Recruiting

  • Amicare Sp z o.o. S.K

    Opoczno,
    Poland

    Site Not Available

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole,
    Poland

    Site Not Available

  • RiverMED Poradnie Specjalistyczne Poznań

    Poznan,
    Poland

    Site Not Available

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Poznan,
    Poland

    Active - Recruiting

  • Centrum Medyczne SOPMED

    Sopot,
    Poland

    Active - Recruiting

  • Endoskopia Sp. z o.o.

    Sopot,
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej SONOMED

    Szczecin,
    Poland

    Active - Recruiting

  • Sonomed Sp. z o.o. Centrum Medyczne

    Szczecin,
    Poland

    Site Not Available

  • Twoja Przychodnia Szczecińskie Centrum Medyczne

    Szczecin,
    Poland

    Site Not Available

  • Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

    Toruń,
    Poland

    Site Not Available

  • H-T Centrum Medyczne

    Tychy,
    Poland

    Site Not Available

  • Office of Jaroslaw Kierkus, Dr N Med

    Warszawa,
    Poland

    Site Not Available

  • Centrum Diagnostyczno - Lecznicze Barska

    Wloclawek,
    Poland

    Site Not Available

  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

    Wrocław,
    Poland

    Site Not Available

  • Centrum Medyczne Oporów

    Wrocław,
    Poland

    Site Not Available

  • Zabobrze Centrum Medyczne

    Wrocław,
    Poland

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Orlando Health, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • GCP Clinical Research

    Tampa, Florida 33609
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates - Emory Saint Joseph's

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Digestive Health Center of Michigan

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Clinical Research Institute of Michigan

    Troy, Michigan 48098
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Digestive Health Associates of Texas-GI Alliance Research-Garland

    Garland, Texas 75044
    United States

    Site Not Available

  • GI Alliance Research - Garland

    Garland, Texas 75044
    United States

    Active - Recruiting

  • Digestive Health Associates of Texas-GI Alliance

    Mansfield, Texas 76003
    United States

    Site Not Available

  • GI Alliance - Texas Digestive Disease Consultants

    Mansfield, Texas 76003
    United States

    Active - Recruiting

  • GI Alliance Research

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Texas Digestive Disease Consultants-GI Alliance Research

    Southlake, Texas 76092
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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