RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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 Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
OD-07656
Experimental intervention
DRUG
Vedolizumab
Active standard of care comparator
Locations (20)
Sunshine Coast University
Birtinya, Australia
Eastern Health
Box Hill, Australia
Coastal Digestive Health
Maroochydore, Australia
Alfred Health
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Royal Melbourne Hospital
Parkville, Australia
Medical University of Graz
Graz, Austria
CHUM
Montreal, Canada
Montreal General Hospital/McGill University
Montreal, Canada
CHUM - Pavillon R
Polička, Czechia
Jordan University Hospital
Amman, Jordan
The Specialty Hospital (TSH) / Advanced Clinical Center
Amman, Jordan
Irbid Specialty Hospital
Irbid, Jordan
The Hospital of Lithuanian University of Health Sciences
Kaunas, Lithuania
IMSP Spitalul Clinic Republican Timofei Moneaga
Chisinau, Moldova
PCRN Auckland
Auckland, New Zealand
PCRN Christchurch
Christchurch, New Zealand
PCRN Waikato
Hamilton, New Zealand
PCRN Tasman
Nelson, New Zealand
PCRN Wellington
Upper Hutt, New Zealand