Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

Odyssey Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis (UC); UC - Ulcerative Colitis

Treatments: Drug: Vedolizumab; Drug: OD-07656

Study type: Interventional

Funder types: Industry

Identifiers

NCT06850727

OD-07656-201

Details and patient eligibility

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.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 3 patient groups

OD-07656 Dosing Regimen 1

Experimental group

Description:

Open Label, Oral, twice daily dose

Treatment:

Drug: OD-07656

Drug: Vedolizumab

OD-07656 Dosing Regimen 2

Experimental group

Description:

Randomized, Oral, twice daily dose

Treatment:

Drug: OD-07656

Drug: Vedolizumab

OD-07656 Dosing Regimen 3

Experimental group

Description:

Randomized, Oral, twice daily dose

Treatment:

Drug: OD-07656

Drug: Vedolizumab