Actively Recruiting
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
Eligibility Criteria
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
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
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
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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