OD-07656 followed by vedolizumab for moderate to severe 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
This test tries OD-07656, followed by vedolizumab, to see if it improves symptoms in people with moderate to severe ulcerative colitis who have not responded well to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Odyssey Therapeutics Industry-sponsored |
| Drugs / interventions | vedolizumab |
| Locations | 32 sites (Birtinya and 31 other locations) |
| Trial ID | NCT06850727 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives participants with moderately to severely active ulcerative colitis OD-07656 and monitors safety and clinical outcomes using measures such as the 3-component Modified Mayo clinic score. Eligible participants are those with inadequate response, loss of response, or intolerance to prior therapies including aminosalicylates, corticosteroids, immunosuppressants, biologics, JAK inhibitors, or S1P modulators. A key objective is to determine whether OD-07656 can enhance the therapeutic benefit of vedolizumab when vedolizumab is administered after OD-07656. Study visits will take place at Australian sites including Sunshine Coast University (Birtinya), Eastern Health (Box Hill), and Coastal Digestive Health (Maroochydore).
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed moderate to severe ulcerative colitis by the 3-component Modified Mayo score who have had inadequate response, loss of response, or intolerance to at least one prior UC therapy.
Not a fit: People with Crohn's disease or indeterminate colitis, those who have had extensive colonic resection or an ostomy, or those with uncontrolled primary sclerosing cholangitis are excluded and likely would not benefit.
Why it matters
Potential benefit: If successful, this approach could help more people achieve symptom control or remission, especially those who have not benefited from existing treatments.
How similar studies have performed: Vedolizumab is an established treatment for UC, but OD-07656 is experimental and using it to boost subsequent vedolizumab response is a novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birtinya and 31 other locations
- 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)
Study contacts
- Study coordinator: Head of Clinical Operations
- Email: clinicaltrials@odysseytx.com
- Phone: 857-393-6160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.