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Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

NCT06850727 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-02-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.

Conditions

  • Ulcerative Colitis (UC)
  • UC - Ulcerative Colitis

Interventions

DRUG

OD-07656

Experimental intervention

DRUG

Vedolizumab

Active standard of care comparator

Sponsors & Collaborators

  • Odyssey Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Odyssey Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-04-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • Jordan
  • Lithuania
  • Moldova
  • New Zealand
  • Poland
  • Ukraine

Study Locations

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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 NCT06850727 on ClinicalTrials.gov