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

NCT06850727 · tracked via the Priya Life Science Canada tracker

Sponsor

Odyssey Therapeutics

Phase

Phase 2

Started

2025-06-02

Last updated

2026-02-11

Condition(s) studied

Ulcerative Colitis (UC)UC - Ulcerative Colitis

Investigational drug(s) / intervention(s)

OD-07656Vedolizumab →

OD-07656: Experimental intervention

Vedolizumab: Active standard of care comparator

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656 — 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.
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment — Up to 12 weeks

Trial sites (32)

Facility	City	Region	Status
Sunshine Coast University	Birtinya	Australia	Recruiting
Eastern Health	Box Hill	Australia	Recruiting
Coastal Digestive Health	Maroochydore	Australia	Recruiting
Alfred Health	Melbourne	Australia	Recruiting
Fiona Stanley Hospital	Murdoch	Australia	Recruiting
Royal Melbourne Hospital	Parkville	Australia	Recruiting
Medical University of Graz	Graz	Austria	Recruiting
CHUM	Montreal	Canada	Recruiting
Montreal General Hospital/McGill University	Montreal	Canada	Recruiting
CHUM - Pavillon R	Polička	Czechia	Recruiting
Jordan University Hospital	Amman	Jordan	Recruiting
The Specialty Hospital (TSH) / Advanced Clinical Center	Amman	Jordan	Recruiting
Irbid Specialty Hospital	Irbid	Jordan	Recruiting
The Hospital of Lithuanian University of Health Sciences	Kaunas	Lithuania	Recruiting
IMSP Spitalul Clinic Republican Timofei Moneaga	Chisinau	Moldova	Recruiting
PCRN Auckland	Auckland	New Zealand	Recruiting
PCRN Christchurch	Christchurch	New Zealand	Recruiting
PCRN Waikato	Hamilton	New Zealand	Recruiting
PCRN Tasman	Nelson	New Zealand	Recruiting
PCRN Wellington	Upper Hutt	New Zealand	Recruiting
Centrum Medyczne	Bydgoszcz	Poland	Recruiting
Centrum Medyczne LukaMed	Chojnice	Poland	Recruiting
Vita Longa Sp. z.o.o.	Katowice	Poland	Recruiting
Centrum Medyczne Medyk	Rzeszów	Poland	Recruiting
Endoskopia Sp. z.o.o	Sopot	Poland	Recruiting
Nowe zdrowie-CK, Kiełtucki	Staszów	Poland	Recruiting
Medical Network Company	Warsaw	Poland	Recruiting
Penta Hospitals Przychodnie	Wroclaw	Poland	Recruiting
Regional Clinical Hospital	Ivano-Frankivsk	Ukraine	Recruiting
Medical centre of ARENSIA Exploratory Medicine LCC	Kyiv	Ukraine	Recruiting
Danylo Halytsky Lviv National Medical University	Lviv	Ukraine	Recruiting
Lviv Regional Clinical Hospital	Lviv	Ukraine	Recruiting

On this site

📄 Entyvio (vedolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06850727 on ClinicalTrials.gov ↗ ← All trials in Canada