Efficacy & Safety of TD-1473 in Ulcerative Colitis

Summary

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Timeline

Start

2019-03-11

Primary completion

2021-10-20

Completion

2021-10-20

Outcome

Missed primary endpoint

Stopped: “Stopped early due to company decision. Company decision based on interim analysis results in TD-1473-0157.”

registry analysis (superiority test); Induction Period: Placebo vs Induction Period: TD-1473 20 mg; p = 0.5809; Least Square Mean Difference -0.27 (95% CI -1.22 to 0.69); ANCOVA NCT03758443 ↗

registry analysis (superiority test); Maintenance Period: Placebo vs Maintenance Period: TD-1473 20 mg; p = 0.3762; Fisher Exact NCT03758443 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IZENCITINIB	Small molecule	—	Oral

Indications