Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT06850727 · Interventional (participants receive a specific treatment) · Lead sponsor: Odyssey Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
OD-07656Vedolizumab
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
32 locations listed.
- Jordan University Hospital - Amman, Jordan
- The Specialty Hospital (TSH) / Advanced Clinical Center - Amman, Jordan
- PCRN Auckland - Auckland, New Zealand
- Sunshine Coast University - Birtinya, Australia
- Eastern Health - Box Hill, Australia
- Centrum Medyczne - Bydgoszcz, Poland
- IMSP Spitalul Clinic Republican Timofei Moneaga - Chisinau, Moldova
- Centrum Medyczne LukaMed - Chojnice, Poland
- PCRN Christchurch - Christchurch, New Zealand
- Medical University of Graz - Graz, Austria
- PCRN Waikato - Hamilton, New Zealand
- Irbid Specialty Hospital - Irbid, Jordan
- Regional Clinical Hospital - Ivano-Frankivsk, Ukraine
- Vita Longa Sp. z.o.o. - Katowice, Poland
- The Hospital of Lithuanian University of Health Sciences - Kaunas, Lithuania
- Medical centre of ARENSIA Exploratory Medicine LCC - Kyiv, Ukraine
- Danylo Halytsky Lviv National Medical University - Lviv, Ukraine
- Lviv Regional Clinical Hospital - Lviv, Ukraine
- Coastal Digestive Health - Maroochydore, Australia
- Alfred Health - Melbourne, Australia
- CHUM - Montreal, Canada
- Montreal General Hospital/McGill University - Montreal, Canada
- Fiona Stanley Hospital - Murdoch, Australia
- PCRN Tasman - Nelson, New Zealand
- Royal Melbourne Hospital - Parkville, Australia
- CHUM - Pavillon R - Polička, Czechia
- Centrum Medyczne Medyk - Rzeszów, Poland
- Endoskopia Sp. z.o.o - Sopot, Poland
- Nowe zdrowie-CK, Kiełtucki - Staszów, Poland
- PCRN Wellington - Upper Hutt, New Zealand
- Medical Network Company - Warsaw, Poland
- Penta Hospitals Przychodnie - Wroclaw, Poland