Ulcerative Colitis (UC)Phase 2NCT06850727
Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
A Phase 2 study testing OD-07656 and Vedolizumab in people with Ulcerative Colitis (UC) and UC - Ulcerative Colitis, run by Odyssey Therapeutics, Inc. at 32 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC), UC - Ulcerative Colitis
- What is being tested?
- OD-07656 and Vedolizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 32 sitesin 10 countries
- Study dates
- 2 Jun 2025to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 10 countries
Poland8 sites, 8 recruiting
- Recruiting
Centrum Medyczne
Bydgoszcz
Study Coordinator
- Recruiting
Centrum Medyczne LukaMed
Chojnice
Study Coordinator
- Recruiting
Vita Longa Sp. z.o.o.
Katowice
Study Coordinator
- Recruiting
Centrum Medyczne Medyk
Rzeszów
Study Coordinator
- Recruiting
Endoskopia Sp. z.o.o
Sopot
Study Coordinator
- Recruiting
Nowe zdrowie-CK, Kiełtucki
Staszów
Study Coordinator
- Recruiting
Medical Network Company
Warsaw
Study Coordinator
- Recruiting
Penta Hospitals Przychodnie
Wroclaw, 54-239
Study Coordinator
Australia6 sites, 6 recruiting
- Recruiting
Sunshine Coast University
Birtinya
Study Coordinator
- Recruiting
Eastern Health
Box Hill
Study Coordinator
- Recruiting
Coastal Digestive Health
Maroochydore
Study Coordinator
- Recruiting
Alfred Health
Melbourne, 3004
Study Coordinator
- Recruiting
Fiona Stanley Hospital
Murdoch, 6150
Study Coordinator
- Recruiting
Royal Melbourne Hospital
Parkville
Study Coordinator
New Zealand5 sites, 5 recruiting
- Recruiting
PCRN Auckland
Auckland, 0622
Study Coordinator
- Recruiting
PCRN Christchurch
Christchurch, 0622
Study Coordinator
- Recruiting
PCRN Waikato
Hamilton, 3200
Study Coordinator
- Recruiting
PCRN Tasman
Nelson, 7011
Study Coordinator
- Recruiting
PCRN Wellington
Upper Hutt, 5018
Study Coordinator
Ukraine4 sites, 4 recruiting
- Recruiting
Regional Clinical Hospital
Ivano-Frankivsk, 76008
Study Coordinator
- Recruiting
Medical centre of ARENSIA Exploratory Medicine LCC
Kyiv, 01135
Study Coordinator
- Recruiting
Danylo Halytsky Lviv National Medical University
Lviv, 79000
Study Coordinator
- Recruiting
Lviv Regional Clinical Hospital
Lviv, 79010
Study Coordinator
Jordan3 sites, 3 recruiting
- Recruiting
Jordan University Hospital
Amman, 11942
Study Coordinator
- Recruiting
The Specialty Hospital (TSH) / Advanced Clinical Center
Amman
Study Coordinator
- Recruiting
Irbid Specialty Hospital
Irbid, 21110
Study Coordinator
Canada2 sites, 2 recruiting
- Recruiting
CHUM
Montreal, H2X OA9
Study Coordinator
- Recruiting
Montreal General Hospital/McGill University
Montreal
Study Coordinator
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz
Study Coordinator
Czechia1 site, 1 recruiting
- Recruiting
CHUM - Pavillon R
Polička, 1549
Study Coordinator
Lithuania1 site, 1 recruiting
- Recruiting
The Hospital of Lithuanian University of Health Sciences
Kaunas
Study Coordinator
Moldova1 site, 1 recruiting
- Recruiting
IMSP Spitalul Clinic Republican Timofei Moneaga
Chisinau, Md-2025
Study Coordinator
About this study
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
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
- Ulcerative Colitis (UC), UC - Ulcerative Colitis
- Being tested
- OD-07656, Vedolizumab
- Keywords
- Ulcertative colitis, Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OD-07656Drug
Experimental intervention
VedolizumabDrug
Active standard of care comparator
| Study group | Role | What they receive |
|---|---|---|
| OD-07656 Dosing Regimen 1 | Experimental | Open Label, Oral, twice daily dose Receives: Drug: OD-07656; Drug: Vedolizumab |
| OD-07656 Dosing Regimen 2 | Experimental | Randomized, Oral, twice daily dose Receives: Drug: OD-07656; Drug: Vedolizumab |
| OD-07656 Dosing Regimen 3 | Experimental | Randomized, Oral, twice daily dose Receives: Drug: OD-07656; Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment
Measured: Up to 12 weeks
Secondary outcomes (2)
Proportion of participants who achieve clinical remission
Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1 and not greater than baseline.
Measured: Baseline and 12 weeks
Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment
Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency scubscore of 0 or 1 and not greater than baseline.
Measured: Baseline and 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start2 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odyssey Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Odyssey Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850727
- Sponsor's protocol ID
- OD-07656-201
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06850727
- Acronym / sponsor ID
- OD-07656-201
- Conditions
- Ulcerative Colitis (UC), UC - Ulcerative Colitis
- Keywords
- Ulcertative colitis, Inflammatory Bowel Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Odyssey Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OD-07656 Dosing Regimen 1 | Experimental | Drug: OD-07656, Drug: VedolizumabOpen Label, Oral, twice daily dose |
| OD-07656 Dosing Regimen 2 | Experimental | Drug: OD-07656, Drug: VedolizumabRandomized, Oral, twice daily dose |
| OD-07656 Dosing Regimen 3 | Experimental | Drug: OD-07656, Drug: VedolizumabRandomized, Oral, twice daily dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Has diagnosis of Crohn's disease or indeterminate colitis
- Has had extensive colonic resection
- Has colostomy or ileostomy
- Has uncontrolled primary sclerosing cholangitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OD-07656Experimental intervention | Drug | OD-07656 Dosing Regimen 1, OD-07656 Dosing Regimen 2, OD-07656 Dosing Regimen 3 |
| VedolizumabActive standard of care comparator | Drug | OD-07656 Dosing Regimen 1, OD-07656 Dosing Regimen 2, OD-07656 Dosing Regimen 3 |
Primary outcome
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
Time frame: 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
Time frame: Up to 12 weeks
2 secondary outcomes
Proportion of participants who achieve clinical remission
Time frame: Baseline and 12 weeks
Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment
Time frame: Baseline and 50 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Medical Officer study director
Odyssey Therapeutics, Inc.
32 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OD-07656 and Vedolizumab in people with Ulcerative Colitis (UC) and UC - Ulcerative Colitis, run by Odyssey Therapeutics, Inc. at 32 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Poland, Australia, New Zealand, Ukraine, Jordan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Operations (857-393-6160, clinicaltrials@odysseytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656 (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.