UCRecruiting
Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
Phase 2 · Testing OD-07656 and Vedolizumab · 32 sites · Odyssey Therapeutics, Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing OD-07656 (a drug) and Vedolizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC) and UC - Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 57 participants are expected to take part.
- Start date: 2025-06-02.
- Main results expected around 2026-04 (estimate from the record).
- 32 study sites listed (32 marked recruiting) in Australia, Austria, Canada, Czechia and Jordan and 5 more countries.
Main thing being measured
- Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656 (Baseline and 12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); UC - Ulcerative Colitis |
| Lead sponsor | Odyssey Therapeutics, Inc. |
| Enrollment | 57 (estimated) |
| Start date | 2025-06-02 |
| Primary completion (est.) | 2026-04 |
| First posted | 2025-02-27 |
| Last updated | 2026-02-11 |
| 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 |
Interventions
- OD-07656 (Drug)
Experimental intervention - Vedolizumab (Drug)
Active standard of care comparator
Full eligibility criteria (from the record)
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
Locations (32)
Show all 32 sites
| Site | City | Country | Site 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.