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

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis

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

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: NX-13 250mg; Drug: NX-13 750mg; Drug: NX-13 Placebo

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
• Italy
  • Milan, Italy
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
  • Roma, Italy
    • Azienda Ospedaliera - Universitaria Sant' Andrea
  • Rozzano, Italy
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
  • San Giovanni Rotondo, Italy
    • IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo
  • Torino, Italy
    • Azienda Ospedaliera Ordine Mauriziano di Torino
• Poland
  • Bydgoszcz, Poland
    • ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy
  • Bydgoszcz, Poland
    • Przychodnia Vitamed NFZ
  • Jelenia Gora, Poland
    • AmiCare Centrum Medyczne
  • Katowice, Poland
    • VITA LONGA Clinic - Katowice
  • Kraków, Poland
    • Krakowska Przychodnia FutureMeds
  • Lodz, Poland
    • Amicare Sp. z o.o. Sp.k.
  • Opoczno, Poland
    • Amicare Sp z o.o. S.K
  • Opole, Poland
    • Twoja Przychodnia Opolskie Centrum Medyczne
  • Poznan, Poland
    • RiverMED Poradnie Specjalistyczne Poznań
  • Sopot, Poland
    • Endoskopia Sp. z o.o.
  • Szczecin, Poland
    • Sonomed Sp. z o.o. Centrum Medyczne
  • Szczecin, Poland
    • Twoja Przychodnia Szczecinskie Centrum Medyczne
  • Toruń, Poland
    • Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
  • Tychy, Poland
    • H-T Centrum Medyczne
  • Warszawa, Poland
    • Office of Jaroslaw Kierkus, Dr n Med
  • Wloclawek, Poland
    • Centrum Diagnostyczno - Lecznicze Barska
  • Wrocław, Poland
    • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
  • Wrocław, Poland
    • Zabobrze Centrum Medyczne
• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc.
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Digestive Health Center of Michigan
    • Troy, Michigan, United States, 48098
      • Clinical Research Institute of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine in St. Louis
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center
  • Texas
    • Garland, Texas, United States, 75044
      • Digestive Health Associates of Texas-GI Alliance Research-Garland
    • Mansfield, Texas, United States, 76003
      • Digestive Health Associates of Texas-GI Alliance
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants-GI Alliance Research
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Criteria:

• Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization;
• Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
• Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD
• Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis
• Bacterial or parasitic pathogenic enteric infection;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NX-13 250mg; Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.	Drug: NX-13 250mg; NX-13 250mg tablet, plus 2 placebo tablets
Experimental: NX-13 750mg; Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.	Drug: NX-13 750mg; NX-13 250mg tablets times 3 to equal 750mg
Placebo Comparator: NX-13 Placebo; Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.	Drug: NX-13 Placebo; NX-13 Placebo tablets times 3 for blinding purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the clinical activity of oral NX-13 vs placebo	Change from baseline in mean Modified Mayo Score (MMS) vs placebo. Total score Modified Mayo score 0-9, with higher scores representing more severe disease activity.	365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability-AE/SAE - Hematology	Treatment Emergent Adverse Event/Serious Adverse Event (TEAEs/SAEs) related to hematology. Assessment will be made by summarizing the percentage of subjects with changes from baseline through routine hematology panel (white blood cells, red blood cells, Hemoglobin, Hematocrit, and platelets). All biomarkers are exploratory objectives.	365 days
Safety and Tolerability-AE/SAE - Chemistry	Treatment Emergent Adverse Event/Serious Adverse Event (TEAEs/SAEs) related to chemistry. Assessment will be made by summarizing the percentage of subjects with changes from baseline through routine chemistry panel (Blood Urea Nitrogren creatinine, Creatine Kinase bilirubin, Aspartate aminotransferase (AST), Alanine transaminase (ALT), Alkaline phosphatase (ALP), Sodium (Na), Potassium (K), Chloride (CL), bicarb, Calcium (CA), Magnesium (MG), Phosphorus, uric acid, total protein, albumin, glucose, Gamma-glutamyl transferase (GGT), total cholesterol, Low-density lipoprotein (LDL), High-density lipoprotein (HDL), and triglycerides) urinalysis, Estimated Glomerular filtration rate (eGFR). All biomarkers are exploratory objectives.	365 days
Safety and Tolerability-AE/SAE - Vital Signs	Treatment Emergent Adverse Event/Serious Adverse Event (TEAEs/SAEs) related to vital signs. Assessment will be made by summarizing the percentage of subjects with changes from baseline through (sitting blood pressure, resting heart rate, and temperature). Changes from baseline deemed clinically significant or associates with AEs (heart rate, pulse rate, QRS, QT, and correct QT).	365 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: AbbVie, AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ulcerative colitis; severe; moderate
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: NX-13-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No