Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06850727

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

Led by Odyssey Therapeutics · Updated on 2026-02-11

57

Participants Needed

32

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of ulcerative colitis (UC)
  • Moderate to severely active UC as defined by the 3-component Modified Mayo clinic score
  • Inadequate response, loss of response, or intolerance/medical contraindication to at least one therapy including oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologics, anti-interleukin 12/23 biologics, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Diagnosis of Crohn's disease or indeterminate colitis
  • Extensive colonic resection
  • Presence of colostomy or ileostomy
  • Uncontrolled primary sclerosing cholangitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

Sunshine Coast University

Birtinya, Australia

Actively Recruiting

2

Eastern Health

Box Hill, Australia

Actively Recruiting

3

Coastal Digestive Health

Maroochydore, Australia

Actively Recruiting

4

Alfred Health

Melbourne, Australia, 3004

Actively Recruiting

5

Fiona Stanley Hospital

Murdoch, Australia, 6150

Actively Recruiting

6

Royal Melbourne Hospital

Parkville, Australia

Actively Recruiting

7

Medical University of Graz

Graz, Austria

Actively Recruiting

8

CHUM

Montreal, Canada, H2X OA9

Actively Recruiting

9

Montreal General Hospital/McGill University

Montreal, Canada

Actively Recruiting

10

CHUM - Pavillon R

Polička, Czechia, 1549

Actively Recruiting

11

Jordan University Hospital

Amman, Jordan, 11942

Actively Recruiting

12

The Specialty Hospital (TSH) / Advanced Clinical Center

Amman, Jordan

Actively Recruiting

13

Irbid Specialty Hospital

Irbid, Jordan, 21110

Actively Recruiting

14

The Hospital of Lithuanian University of Health Sciences

Kaunas, Lithuania

Actively Recruiting

15

IMSP Spitalul Clinic Republican Timofei Moneaga

Chisinau, Moldova, Md-2025

Actively Recruiting

16

PCRN Auckland

Auckland, New Zealand, 0622

Actively Recruiting

17

PCRN Christchurch

Christchurch, New Zealand, 0622

Actively Recruiting

18

PCRN Waikato

Hamilton, New Zealand, 3200

Actively Recruiting

19

PCRN Tasman

Nelson, New Zealand, 7011

Actively Recruiting

20

PCRN Wellington

Upper Hutt, New Zealand, 5018

Actively Recruiting

21

Centrum Medyczne

Bydgoszcz, Poland

Actively Recruiting

22

Centrum Medyczne LukaMed

Chojnice, Poland

Actively Recruiting

23

Vita Longa Sp. z.o.o.

Katowice, Poland

Actively Recruiting

24

Centrum Medyczne Medyk

Rzeszów, Poland

Actively Recruiting

25

Endoskopia Sp. z.o.o

Sopot, Poland

Actively Recruiting

26

Nowe zdrowie-CK, Kiełtucki

Staszów, Poland

Actively Recruiting

27

Medical Network Company

Warsaw, Poland

Actively Recruiting

28

Penta Hospitals Przychodnie

Wroclaw, Poland, 54-239

Actively Recruiting

29

Regional Clinical Hospital

Ivano-Frankivsk, Ukraine, 76008

Actively Recruiting

30

Medical centre of ARENSIA Exploratory Medicine LCC

Kyiv, Ukraine, 01135

Actively Recruiting

31

Danylo Halytsky Lviv National Medical University

Lviv, Ukraine, 79000

Actively Recruiting

32

Lviv Regional Clinical Hospital

Lviv, Ukraine, 79010

Actively Recruiting

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Research Team

H

Head of Clinical Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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