NCT05785715

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-24
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-03-27
• Last updated: 2025-07-01

Locations

35 sites across 4 countries: United States, Belgium, Italy, Poland

Regulatory

• FDA-regulated drug study