Recruiting
Phase 2

OD-07656 & Vedolizumab

Sponsor:

Odyssey Therapeutics

Code:

NCT06850727

Conditions

Ulcerative Colitis (UC)

UC - Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

OD-07656

Vedolizumab

Study Details

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.

Conditions

Ulcerative Colitis (UC)

UC - Ulcerative Colitis

Study ID

NCT06850727

Start date

Jun 2, 2025

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OD-07656 Dosing Regimen 1

Open Label, Oral, twice daily dose

experimental: OD-07656 Dosing Regimen 2

Randomized, Oral, twice daily dose

experimental: OD-07656 Dosing Regimen 3

Randomized, Oral, twice daily dose

Interventions

OD-07656

Experimental intervention

Vedolizumab

Active standard of care comparator

Primary outcome measure

  • Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656 [ Time Frame: Baseline and 12 weeks ]
  • Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Head of Clinical Operations

857-393-6160clinicaltrials@odysseytx.com

Locations

CHUM

Recruiting

Montreal, Canada, H2X OA9

Montreal General Hospital/McGill University

Recruiting

Montreal, Canada

More Information

Sponsor

Odyssey Therapeutics

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Ulcertative colitis
  • Inflammatory Bowel Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Odyssey Therapeutics on 2026-02-11.