NCT06850727RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- First submitted
- 22 Feb 2025
- Start date
- 2 Jun 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- Odyssey Therapeutics, Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT06850727
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 57
- From 2 Jun 2025 to the primary completion date, Apr 2026
- 32 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had extensive colonic resection
Other illness
- Has diagnosis of Crohn's disease or indeterminate colitis
Other
- The main exclusion criteria include but are not limited to the following:
- Has colostomy or ileostomy
- Has uncontrolled primary sclerosing cholangitis
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Sunshine Coast University Coordinator of this site? Confirm its status | Birtinya | Australia | Recruiting |
| Eastern Health Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Coastal Digestive Health Coordinator of this site? Confirm its status | Maroochydore | Australia | Recruiting |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Montreal General Hospital/McGill University Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| CHUM - Pavillon R Coordinator of this site? Confirm its status | Polička | Czechia | Recruiting |
| The Specialty Hospital (TSH) / Advanced Clinical Center Coordinator of this site? Confirm its status | Amman | Jordan | Recruiting |
| Jordan University Hospital Coordinator of this site? Confirm its status | Amman | Jordan | Recruiting |
| Irbid Specialty Hospital Coordinator of this site? Confirm its status | Irbid | Jordan | Recruiting |
| The Hospital of Lithuanian University of Health Sciences Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| IMSP Spitalul Clinic Republican Timofei Moneaga Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| PCRN Auckland Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| PCRN Christchurch Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| PCRN Waikato Coordinator of this site? Confirm its status | Hamilton | New Zealand | Recruiting |
| PCRN Tasman Coordinator of this site? Confirm its status | Nelson | New Zealand | Recruiting |
| PCRN Wellington Coordinator of this site? Confirm its status | Upper Hutt | New Zealand | Recruiting |
| Centrum Medyczne Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Lukamed Coordinator of this site? Confirm its status | Chojnice | Poland | Recruiting |
| Vita Longa Sp. Z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Centrum Medyczne Medyk Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Endoskopia Sp z o.o. Coordinator of this site? Confirm its status | Sopot | Poland | Recruiting |
| Nowe zdrowie-CK, Kiełtucki Coordinator of this site? Confirm its status | Staszów | Poland | Recruiting |
| Medical Network Company Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Penta Hospitals Przychodnie Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Regional Clinical Hospital Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Recruiting |
| Medical centre of ARENSIA Exploratory Medicine LCC Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Lviv Regional Clinical Hospital Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
| Danylo Halytsky Lviv National Medical University Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.