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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
OD-07656
DrugExperimental intervention
Vedolizumab
DrugActive standard of care comparator
Treatment groups
57 Participants
are divided into 3 treatment groupsGroup A: OD-07656 Dosing Regimen 1Experimental treatment 2 interventions
Group B: OD-07656 Dosing Regimen 2Experimental treatment 2 interventions
Group C: OD-07656 Dosing Regimen 3Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
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.
Time frame
Baseline and 12 weeks2
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment
Time frame
Up to 12 weeksSecondary outcomes
1
Proportion of participants who achieve clinical remission
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.
Time frame
Baseline and 12 weeks2
Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment
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.
Time frame
Baseline and 50 weeksSponsors and contacts
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Source ClinicalTrials.gov