Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOdyssey Therapeutics
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Has diagnosis of Crohn's disease or indeterminate colitis
Has had extensive colonic resection
Has colostomy or ileostomy
Has uncontrolled primary sclerosing cholangitis
Trial design
Treatments tested in this trial
- OD-07656
- Vedolizumab
Treatment groups
57 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov