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

Phase 2

Recruiting

• Conditions: Ulcerative Colitis (UC); UC - Ulcerative Colitis
• Interventions: Drug: OD-07656; Drug: Vedolizumab

• Registration Number: NCT06850727
• Lead Sponsor: Odyssey Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-22
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-27
• Study Start: 2025-06-02
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OD-07656 Dosing Regimen 1	OD-07656	Open Label, Oral, twice daily dose
OD-07656 Dosing Regimen 2	OD-07656	Randomized, Oral, twice daily dose
OD-07656 Dosing Regimen 3	OD-07656	Randomized, Oral, twice daily dose
OD-07656 Dosing Regimen 3	Vedolizumab	Randomized, Oral, twice daily dose
OD-07656 Dosing Regimen 1	Vedolizumab	Open Label, Oral, twice daily dose
OD-07656 Dosing Regimen 2	Vedolizumab	Randomized, Oral, twice daily dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Alfred Health; 🇦🇺 Melbourne, Australia

IMSP Spitalul Clinic Republican Timofei Moneaga; 🇲🇩 Chisinau, Moldova, Republic of

PCRN Auckland; 🇳🇿 Auckland, New Zealand

PCRN Waikato; 🇳🇿 Hamilton, New Zealand