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NCT Number: NCT06850727

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

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases UC - Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sunshine Coast University, Birtinya, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OD-07656

Drug

Experimental intervention

Vedolizumab

Drug

Active standard of care comparator

Primary outcomes

  1. Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656

    Time frame: 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.

  2. Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Proportion of participants who achieve clinical remission

    Time frame: 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.

  2. Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Head of Clinical Operations

CONTACT

[email protected]

857-393-6160

Sponsors and collaborators

Lead sponsor

Odyssey Therapeutics

Industry

Registry information

Official study title

A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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