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Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
Sponsor: Odyssey Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2025-06-02
Completion Date
2026-11
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
OD-07656
Experimental intervention
Vedolizumab
Active standard of care comparator
Locations (32)
Sunshine Coast University
Birtinya, Australia
Eastern Health
Box Hill, Australia
Coastal Digestive Health
Maroochydore, Australia
Alfred Health
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Royal Melbourne Hospital
Parkville, Australia
Medical University of Graz
Graz, Austria
CHUM
Montreal, Canada
Montreal General Hospital/McGill University
Montreal, Canada
CHUM - Pavillon R
Polička, Czechia
Jordan University Hospital
Amman, Jordan
The Specialty Hospital (TSH) / Advanced Clinical Center
Amman, Jordan
Irbid Specialty Hospital
Irbid, Jordan
The Hospital of Lithuanian University of Health Sciences
Kaunas, Lithuania
IMSP Spitalul Clinic Republican Timofei Moneaga
Chisinau, Moldova
PCRN Auckland
Auckland, New Zealand
PCRN Christchurch
Christchurch, New Zealand
PCRN Waikato
Hamilton, New Zealand
PCRN Tasman
Nelson, New Zealand
PCRN Wellington
Upper Hutt, New Zealand
Centrum Medyczne
Bydgoszcz, Poland
Centrum Medyczne LukaMed
Chojnice, Poland
Vita Longa Sp. z.o.o.
Katowice, Poland
Centrum Medyczne Medyk
Rzeszów, Poland
Endoskopia Sp. z.o.o
Sopot, Poland
Nowe zdrowie-CK, Kiełtucki
Staszów, Poland
Medical Network Company
Warsaw, Poland
Penta Hospitals Przychodnie
Wroclaw, Poland
Regional Clinical Hospital
Ivano-Frankivsk, Ukraine
Medical centre of ARENSIA Exploratory Medicine LCC
Kyiv, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, Ukraine
Lviv Regional Clinical Hospital
Lviv, Ukraine