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

Summary

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

Timeline

Start

2023-04-24

Primary completion

2025-05-30

Completion

2025-05-30

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor Decision\_Not Safety Related”

registry analysis (superiority test); Induction Period: NX-13 250 mg vs Induction Period: Placebo; LS Mean Difference -0.18 (90% CI -1.33 to 0.97) NCT05785715 ↗

registry analysis (superiority test); Induction Period: NX-13 750 mg vs Induction Period: Placebo; LS Mean Difference 0.12 (90% CI -1.03 to 1.28) NCT05785715 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NX-13	Unknown	250 mg	Oral
Subject	NX-13	Unknown	750 mg	Oral

Indications