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

NCT ID: NCT05785715

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2025-05-30

Brief Summary

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

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).

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

NX-13 250mg

Intervention Type: DRUG

NX-13 250mg tablet, plus 2 placebo tablets

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.

Group Type: EXPERIMENTAL

NX-13 750mg

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

NX-13 Placebo

Intervention Type: DRUG

NX-13 Placebo tablets times 3 for blinding purposes

Interventions

NX-13 250mg

NX-13 250mg tablet, plus 2 placebo tablets

Intervention Type: DRUG

NX-13 750mg

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

Intervention Type: DRUG

NX-13 Placebo

NX-13 Placebo tablets times 3 for blinding purposes

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie

Role: STUDY_DIRECTOR

AbbVie

Locations

Miami Clinical Research

Miami, Florida, United States

Orlando Health, Inc.

Orlando, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

Digestive Health Center of Michigan

Chesterfield, Michigan, United States

Clinical Research Institute of Michigan

Troy, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Digestive Health Associates of Texas-GI Alliance Research-Garland

Garland, Texas, United States

Digestive Health Associates of Texas-GI Alliance

Mansfield, Texas, United States

Texas Digestive Disease Consultants-GI Alliance Research

Southlake, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, , Belgium

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

Milan, , Italy

Azienda Ospedaliera - Universitaria Sant' Andrea

Roma, , Italy

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

Rozzano, , Italy

IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo

San Giovanni Rotondo, , Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, , Italy

ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy

Bydgoszcz, , Poland

Przychodnia Vitamed NFZ

Bydgoszcz, , Poland

AmiCare Centrum Medyczne

Jelenia Góra, , Poland

VITA LONGA Clinic - Katowice

Katowice, , Poland

Krakowska Przychodnia FutureMeds

Krakow, , Poland

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

Lodz, , Poland

Amicare Sp z o.o. S.K

Opoczno, , Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, , Poland

RiverMED Poradnie Specjalistyczne Poznań

Poznan, , Poland

Endoskopia Sp. z o.o.

Sopot, , Poland

Sonomed Sp. z o.o. Centrum Medyczne

Szczecin, , Poland

Twoja Przychodnia Szczecińskie Centrum Medyczne

Szczecin, , Poland

Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

Torun, , Poland

H-T Centrum Medyczne

Tychy, , Poland

Office of Jaroslaw Kierkus, Dr N Med

Warsaw, , Poland

Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

Wroclaw, , Poland

Zabobrze Centrum Medyczne

Wroclaw, , Poland

Centrum Diagnostyczno - Lecznicze Barska

Włocławek, , Poland

Countries

United States; Belgium; Italy; Poland

Other Identifiers

NX-13-201

Identifier Type: -

Identifier Source: org_study_id