Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
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
1 other identifier
interventional
57
9 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2025
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedFebruary 11, 2026
February 1, 2026
10 months
February 22, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
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
Up to 12 weeks
Secondary Outcomes (2)
Proportion of participants who achieve clinical remission
Baseline and 12 weeks
Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment
Baseline and 50 weeks
Study Arms (3)
OD-07656 Dosing Regimen 1
EXPERIMENTALOpen Label, Oral, twice daily dose
OD-07656 Dosing Regimen 2
EXPERIMENTALRandomized, Oral, twice daily dose
OD-07656 Dosing Regimen 3
EXPERIMENTALRandomized, Oral, twice daily dose
Interventions
Experimental intervention
Active standard of care comparator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has diagnosis of Crohn's disease or indeterminate colitis
- Has had extensive colonic resection
- Has colostomy or ileostomy
- Has uncontrolled primary sclerosing cholangitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Sunshine Coast University
Birtinya, Australia
Eastern Health
Box Hill, Australia
Coastal Digestive Health
Maroochydore, Australia
Alfred Health
Melbourne, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Royal Melbourne Hospital
Parkville, Australia
Medical University of Graz
Graz, Austria
CHUM
Montreal, H2X OA9, Canada
Montreal General Hospital/McGill University
Montreal, Canada
CHUM - Pavillon R
Polička, 1549, Czechia
Jordan University Hospital
Amman, 11942, Jordan
The Specialty Hospital (TSH) / Advanced Clinical Center
Amman, Jordan
Irbid Specialty Hospital
Irbid, 21110, Jordan
The Hospital of Lithuanian University of Health Sciences
Kaunas, Lithuania
IMSP Spitalul Clinic Republican Timofei Moneaga
Chisinau, Md-2025, Moldova
PCRN Auckland
Auckland, 0622, New Zealand
PCRN Christchurch
Christchurch, 0622, New Zealand
PCRN Waikato
Hamilton, 3200, New Zealand
PCRN Tasman
Nelson, 7011, New Zealand
PCRN Wellington
Upper Hutt, 5018, 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, 54-239, Poland
Regional Clinical Hospital
Ivano-Frankivsk, 76008, Ukraine
Medical centre of ARENSIA Exploratory Medicine LCC
Kyiv, 01135, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, 79000, Ukraine
Lviv Regional Clinical Hospital
Lviv, 79010, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Odyssey Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2025
First Posted
February 27, 2025
Study Start
June 2, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02