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

February 9, 2026 updated by: Odyssey Therapeutics

A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Birtinya, Australia
        • Recruiting
        • Sunshine Coast University
        • Contact:
          • Study Coordinator
      • Box Hill, Australia
        • Recruiting
        • Eastern Health
        • Contact:
          • Study Coordinator
      • Maroochydore, Australia
        • Recruiting
        • Coastal Digestive Health
        • Contact:
          • Study Coordinator
      • Melbourne, Australia, 3004
        • Recruiting
        • Alfred Health
        • Contact:
          • Study Coordinator
      • Murdoch, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Study Coordinator
      • Parkville, Australia
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:
          • Study Coordinator
  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University of Graz
        • Contact:
          • Study Coordinator
  • Canada
      • Montreal, Canada, H2X OA9
        • Recruiting
        • CHUM
        • Contact:
          • Study Coordinator
      • Montreal, Canada
        • Recruiting
        • Montreal General Hospital/McGill University
        • Contact:
          • Study Coordinator
  • Czechia
      • Polička, Czechia, 1549
        • Recruiting
        • CHUM - Pavillon R
        • Contact:
          • Study Coordinator
  • Jordan
      • Amman, Jordan, 11942
        • Recruiting
        • Jordan University Hospital
        • Contact:
          • Study Coordinator
      • Amman, Jordan
        • Recruiting
        • The Specialty Hospital (TSH) / Advanced Clinical Center
        • Contact:
          • Study Coordinator
      • Irbid, Jordan, 21110
        • Recruiting
        • Irbid Specialty Hospital
        • Contact:
          • Study Coordinator
  • Lithuania
      • Kaunas, Lithuania
        • Recruiting
        • The Hospital of Lithuanian University of Health Sciences
        • Contact:
          • Study Coordinator
  • Moldova
      • Chisinau, Moldova, Md-2025
        • Recruiting
        • IMSP Spitalul Clinic Republican Timofei Moneaga
        • Contact:
          • Study Coordinator
  • New Zealand
      • Auckland, New Zealand, 0622
        • Recruiting
        • PCRN Auckland
        • Contact:
          • Study Coordinator
      • Christchurch, New Zealand, 0622
        • Recruiting
        • PCRN Christchurch
        • Contact:
          • Study Coordinator
      • Hamilton, New Zealand, 3200
        • Recruiting
        • PCRN Waikato
        • Contact:
          • Study Coordinator
      • Nelson, New Zealand, 7011
        • Recruiting
        • PCRN Tasman
        • Contact:
          • Study Coordinator
      • Upper Hutt, New Zealand, 5018
        • Recruiting
        • PCRN Wellington
        • Contact:
          • Study Coordinator
  • Poland
      • Bydgoszcz, Poland
        • Recruiting
        • Centrum Medyczne
        • Contact:
          • Study Coordinator
      • Chojnice, Poland
        • Recruiting
        • Centrum Medyczne Lukamed
        • Contact:
          • Study Coordinator
      • Katowice, Poland
        • Recruiting
        • Vita Longa Sp. z.o.o.
        • Contact:
          • Study Coordinator
      • Rzeszów, Poland
        • Recruiting
        • Centrum Medyczne MEDYK
        • Contact:
          • Study Coordinator
      • Sopot, Poland
        • Recruiting
        • Endoskopia Sp. z.o.o
        • Contact:
          • Study Coordinator
      • Staszów, Poland
        • Recruiting
        • Nowe zdrowie-CK, Kiełtucki
        • Contact:
          • Study Coordinator
      • Warsaw, Poland
        • Recruiting
        • Medical Network Company
        • Contact:
          • Study Coordinator
      • Wroclaw, Poland, 54-239
        • Recruiting
        • Penta Hospitals Przychodnie
        • Contact:
          • Study Coordinator
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Recruiting
        • Regional Clinical Hospital
        • Contact:
          • Study Coordinator
      • Kyiv, Ukraine, 01135
        • Recruiting
        • Medical centre of ARENSIA Exploratory Medicine LCC
        • Contact:
          • Study Coordinator
      • Lviv, Ukraine, 79010
        • Recruiting
        • Lviv Regional Clinical Hospital
        • Contact:
          • Study Coordinator
      • Lviv, Ukraine, 79000
        • Recruiting
        • Danylo Halytsky Lviv National Medical University
        • Contact:
          • Study Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a confirmed diagnosis of ulcerative colitis (UC)
  • Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score
  • Has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has diagnosis of Crohn's disease or indeterminate colitis
  • Has had extensive colonic resection
  • Has colostomy or ileostomy
  • Has uncontrolled primary sclerosing cholangitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OD-07656 Dosing Regimen 1
Open Label, Oral, twice daily dose
Drug: OD-07656
Experimental intervention
Drug: Vedolizumab
Active standard of care comparator
Experimental: OD-07656 Dosing Regimen 2
Randomized, Oral, twice daily dose
Drug: OD-07656
Experimental intervention
Drug: Vedolizumab
Active standard of care comparator
Experimental: OD-07656 Dosing Regimen 3
Randomized, Oral, twice daily dose
Drug: OD-07656
Experimental intervention
Drug: Vedolizumab
Active standard of care comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
Time Frame: Baseline and 12 weeks
The 3-component MMCS ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding and stool frequency subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease.
Baseline and 12 weeks
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who achieve clinical remission
Time Frame: Baseline and 12 weeks
Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1 and not greater than baseline.
Baseline and 12 weeks
Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment
Time Frame: Baseline and 50 weeks
Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency scubscore of 0 or 1 and not greater than baseline.
Baseline and 50 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odyssey Therapeutics

Investigators

  • Study Director: Chief Medical Officer, Odyssey Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OD-07656-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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