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

NCT04353791 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

  • Ulcerative Colitis Chronic Moderate
  • Ulcerative Colitis Chronic Severe

Interventions

DRUG

OST-122

Active dose

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Oncostellae S.L

    lead INDUSTRY

Principal Investigators

  • Ascensión Heredia Rodríguez, PhD · Oncostellae S.L

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-12-27
Completion
2022-12-27

Countries

  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT04353791 on ClinicalTrials.gov