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

May 19, 2026 updated by: AbbVie

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Góra, Poland
        • AmiCare Centrum Medyczne
      • Katowice, Poland
        • VITA LONGA Clinic - Katowice
      • Krakow, 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 Szczecińskie Centrum Medyczne
      • Torun, Poland
        • Torunskiego Centrum Gastrologii I Endoskopii - Gastromed
      • Tychy, Poland
        • H-T Centrum Medyczne
      • Warsaw, Poland
        • Office of Jaroslaw Kierkus, Dr N Med
      • Wroclaw, Poland
        • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
      • Wroclaw, Poland
        • Zabobrze Centrum Medyczne
      • Włocławek, Poland
        • Centrum Diagnostyczno - Lecznicze Barska
  • 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
      • St 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Change From Baseline in Modified Mayo Score (MMS) at Week 12
Time Frame: Baseline, Week 12
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency [SFS], rectal bleeding [RBS] and finding on endoscopy [ES]), each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. A negative change in MMS score indicates improvement.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Induction Period
Time Frame: Baseline up to Week 12
Treatment-emergent adverse events (TEAEs) were defined as AEs that occurred after the participant received first dose of study treatment or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment until 21 days after the date and time of last dose of study drug. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
Baseline up to Week 12
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Induction Period
Time Frame: Baseline up to Week 12
SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.
Baseline up to Week 12
Number of Participants With Clinical Remission Per MMS at Week 12
Time Frame: Week 12

Clinical Remission per MMS was defined as achieving MMS <=2, with RBS =0, SFS <=1 and not greater than baseline, and ES <=1.

The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease). A lower MMS indicates better health status.
Week 12
Number of Participants With MMS <=2 at Week 12
Time Frame: Week 12
The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES), each of which ranges from 0 (normal) to 3 (severe disease). A lower MMS indicates better health status.
Week 12
Number of Participants With Robarts Histopathology Index (RHI) Score <=3 at Week 12
Time Frame: Week 12
The Robarts Histopathology Index (RHI) score is used to assess the disease severity. The RHI is defined as the sum of four weighted items from Geboes: Grade 1: lamina propria chronic inflammation; Grade 2B: lamina propria neutrophils; Grade 3: epithelial neutrophils; Grade 5: surface epithelial injury. Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity) with a higher score indicating more severity.
Week 12
Number of Participants With Clinical Response Per MMS at Week 12
Time Frame: Baseline, Week 12

Clinical Response was defined as >=2 Points and >=30% decrease from baseline in MMS with >=1 point decrease in RBS or RBS <=1.

The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Baseline, Week 12
Number of Participants With Endoscopic Response at Week 12
Time Frame: Week 12

Endoscopic Response was defined as ES <=1.

The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Week 12
Number of Participants With Endoscopic Remission at Week 12
Time Frame: Week 12

Endoscopic Remission was defined as ES =0.

The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Week 12
Number of Participants With Endoscopic-histologic Mucosal Improvement at Week 12
Time Frame: Week 12

Endoscopic-histologic Mucosal Improvement was defined as ES <=1 and Geboes score <2.0.

The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status.
Week 12
Number of Participants With Histologic Endoscopic Mucosal Improvement (HEMI) at Week 12
Time Frame: Week 12

HEMI was defined as ES <=1 and Geboes score <3.1.

The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status.
Week 12
Number of Participants With Histologic Endoscopic Mucosal Remission (HEMR) at Week 12
Time Frame: Week 12

HEMR was defined as ES = 0 and Geboes score <2.0.

The ES subscore of the MMS ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status. The Geboes scoring system is a stepwise ordinal grading system for histological assessment of disease severity in UC. The Geboes score includes 7 histological items (Grade 0 Grade 5) with a total score summed to a continuous variable, ranging from 0 to 22. Lower Geboes scores indicate better health status.
Week 12
Number of Participants With Symptomatic Remission at Week 12
Time Frame: Baseline, Week 12

Symptomatic remission was defined as RBS = 0 and (i) SFS = 0 or (ii) SFS = 1 with baseline SFS >2, at Week 12.

The MMS ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (SFS, RBS, and ES) each of which ranges from 0 (normal) to 3 (severe disease) with lower scores indicating better health status.
Baseline, Week 12
Number of Participants With Clinical Response Per Partial MMS at Week 4
Time Frame: Baseline, Week 4

Clinical response per partial MMS was defined as achieving >=1 points and >=30% decrease from baseline in partial MMS, with >=1 point decrease in RBS or RBS <=1.

Partial MMS ranges from 0 (normal or inactive disease) to 6 (severe disease) and is calculated as the sum of 2 subscores (SFS and RBS), each of which ranges from 0 (normal) to 3 (severe disease). A lower partial MMS indicates better health status.
Baseline, Week 4
Number of Participants With Abdominal Pain Score = 0 at Week 12
Time Frame: Week 12
Participants rated their abdominal pain on a scale from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating more pain.
Week 12
Number of Participants With Rectal Urgency Score = 0 at Week 12
Time Frame: Week 12
The rectal urgency score is based on the number of times participants must rush to the toilet to have a bowel movement. The score ranges from 0 (2 or fewer events) to 10 (12 or more events), with higher scores representing more severe symptoms.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: AbbVie, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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