NCT04353791

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

A Phase Ib/IIa, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Treatment With OST-122 in Patients With Moderate to Severe Ulcerative Colitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Oncostellae S.L · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase Ib/IIa to evaluate the safety and tolerability of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis over 28 days. This trial will also explore pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with OST-122 through biomarker analysis and clinical, endoscopic and histologic assessments.

Detailed description

OST-122 is an oral, gut-restricted and subtype-selective Jak3/Tyk2/Ark5 inhibitor for the local treatment of inflammatory bowel disease (IBD) including ulcerative colitis, Crohn's disease and, potentially, fibrotic lesions in Crohn's patients. The compound was well tolerated in a Phase 1 study in healthy volunteers and has been shown to be stable during the GI transit, while no significant plasma levels were detected. The gut-restricted PK profile of OST-122 lowers the risk of systemic toxicities inherent to other JAK inhibitors. In the current proof of concept study, the compound's safety, PK profile and trends of efficacy will be investigated in patients with moderate to severe ulcerative colitis.

Conditions

• Ulcerative Colitis Chronic Moderate
• Ulcerative Colitis Chronic Severe

Interventions

Type	Name	Description
DRUG	OST-122	Active dose
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-09-16
• Primary completion: 2022-12-27
• Completion: 2022-12-27
• First posted: 2020-04-20
• Last updated: 2023-01-13

Locations

16 sites across 2 countries: Spain, Ukraine