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

NCT05785715 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-07-01

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

NX-13 250mg

NX-13 250mg tablet, plus 2 placebo tablets

DRUG

NX-13 750mg

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

DRUG

NX-13 Placebo

NX-13 Placebo tablets times 3 for blinding purposes

Sponsors & Collaborators

Principal Investigators

  • AbbVie · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-24
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785715 on ClinicalTrials.gov