Ulcerative Colitis (UC), UC - Ulcerative Colitis
Conditions
Keywords
Ulcertative colitis, Inflammatory Bowel Diseases
Brief summary
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.
Interventions
DRUGOD-07656
Experimental intervention
DRUGVedolizumab
Active standard of care comparator
Sponsors
Odyssey Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656 | Baseline and 12 weeks | The 3-component MMCS ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding and stool frequency subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. |
| Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment | Up to 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve clinical remission | Baseline and 12 weeks | Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1 and not greater than baseline. |
| Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment | Baseline and 50 weeks | Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency scubscore of 0 or 1 and not greater than baseline. |
Countries
Australia, Austria, Canada, Czechia, Jordan, Lithuania, Moldova, New Zealand, Poland, Ukraine
Contacts
CONTACTHead of Clinical Operations
STUDY_DIRECTORChief Medical Officer
Odyssey Therapeutics
Outcome results
None listed