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

NCT05785715 | Terminated Phase 2 FDA Drug

• 1 other identifier: NX-13-201
• Study Type: interventional
• Target: 81
• Locations: 4 countries
• Sites: 35

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis; moderate; severe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Safety and Tolerability-AE/SAE - Hematology

  365 days

• Safety and Tolerability-AE/SAE - Chemistry

  365 days

• Safety and Tolerability-AE/SAE - Vital Signs

  365 days

Study Arms (3)

NX-13 250mg

EXPERIMENTAL

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 750mg

EXPERIMENTAL

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 Placebo

PLACEBO COMPARATOR

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

Interventions

NX-13 250mg DRUG

NX-13 250mg tablet, plus 2 placebo tablets

NX-13 250mg

NX-13 750mg DRUG

NX-13 250mg tablets times 3 to equal 750mg

NX-13 750mg

NX-13 Placebo DRUG

NX-13 Placebo tablets times 3 for blinding purposes

NX-13 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AbbVie: lead

Study Sites (35)

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

GCP Clinical Research

Tampa, Florida, 33609, United States

Location

Digestive Health Center of Michigan

Chesterfield, Michigan, 48047, United States

Location

Clinical Research Institute of Michigan

Troy, Michigan, 48098, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Digestive Health Associates of Texas-GI Alliance Research-Garland

Garland, Texas, 75044, United States

Location

Digestive Health Associates of Texas-GI Alliance

Mansfield, Texas, 76003, United States

Location

Texas Digestive Disease Consultants-GI Alliance Research

Southlake, Texas, 76092, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

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

Milan, Italy

Location

Azienda Ospedaliera - Universitaria Sant' Andrea

Roma, Italy

Location

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

Rozzano, Italy

Location

IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo

San Giovanni Rotondo, Italy

Location

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Italy

Location

ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy

Bydgoszcz, Poland

Location

Przychodnia Vitamed NFZ

Bydgoszcz, Poland

Location

AmiCare Centrum Medyczne

Jelenia Góra, Poland

Location

VITA LONGA Clinic - Katowice

Katowice, Poland

Location

Krakowska Przychodnia FutureMeds

Krakow, Poland

Location

AmiCare Sp. z o.o. Sp.k.

Lodz, Poland

Location

Amicare Sp z o.o. S.K

Opoczno, Poland

Location

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, Poland

Location

RiverMED Poradnie Specjalistyczne Poznań

Poznan, Poland

Location

Endoskopia Sp. z o.o.

Sopot, Poland

Location

Sonomed Sp. z o.o. Centrum Medyczne

Szczecin, Poland

Location

Twoja Przychodnia Szczecińskie Centrum Medyczne

Szczecin, Poland

Location

Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

Torun, Poland

Location

H-T Centrum Medyczne

Tychy, Poland

Location

Office of Jaroslaw Kierkus, Dr N Med

Warsaw, Poland

Location

Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

Wroclaw, Poland

Location

Zabobrze Centrum Medyczne

Wroclaw, Poland

Location

Centrum Diagnostyczno - Lecznicze Barska

Włocławek, Poland

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Lymphoma, Follicular

Interventions

NX-13

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• AbbVie

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 27, 2023
• Study Start: April 24, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); BE (1); PL (18); IT (5)