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NCT06850727RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 11 Feb 2026

Next steps

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
57 (estimated)
First submitted
22 Feb 2025
Start date
2 Jun 2025
Primary completion date
Apr 2026
Lead sponsor
Odyssey Therapeutics, Inc.
NCT number
NCT06850727

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 57
  • From 2 Jun 2025 to the primary completion date, Apr 2026
  • 32 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had extensive colonic resection

Other illness

  • Has diagnosis of Crohn's disease or indeterminate colitis

Other

  • The main exclusion criteria include but are not limited to the following:
  • Has colostomy or ileostomy
  • Has uncontrolled primary sclerosing cholangitis

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical University of GrazGrazAustriaRecruiting
Sunshine Coast UniversityBirtinyaAustraliaRecruiting
Eastern HealthBox HillAustraliaRecruiting
Coastal Digestive HealthMaroochydoreAustraliaRecruiting
Alfred HealthMelbourneAustraliaRecruiting
Fiona Stanley HospitalMurdochAustraliaRecruiting
Royal Melbourne HospitalParkvilleAustraliaRecruiting
CHUMMontrealCanadaRecruiting
Montreal General Hospital/McGill UniversityMontrealCanadaRecruiting
CHUM - Pavillon RPoličkaCzechiaRecruiting
The Specialty Hospital (TSH) / Advanced Clinical CenterAmmanJordanRecruiting
Jordan University HospitalAmmanJordanRecruiting
Irbid Specialty HospitalIrbidJordanRecruiting
The Hospital of Lithuanian University of Health SciencesKaunasLithuaniaRecruiting
IMSP Spitalul Clinic Republican Timofei MoneagaChisinauMoldovaRecruiting
PCRN AucklandAucklandNew ZealandRecruiting
PCRN ChristchurchChristchurchNew ZealandRecruiting
PCRN WaikatoHamiltonNew ZealandRecruiting
PCRN TasmanNelsonNew ZealandRecruiting
PCRN WellingtonUpper HuttNew ZealandRecruiting
Centrum MedyczneBydgoszczPolandRecruiting
Centrum Medyczne LukamedChojnicePolandRecruiting
Vita Longa Sp. Z o.o.KatowicePolandRecruiting
Centrum Medyczne MedykRzeszówPolandRecruiting
Endoskopia Sp z o.o.SopotPolandRecruiting
Nowe zdrowie-CK, KiełtuckiStaszówPolandRecruiting
Medical Network CompanyWarsawPolandRecruiting
Penta Hospitals PrzychodnieWroclawPolandRecruiting
Regional Clinical HospitalIvano-FrankivskUkraineRecruiting
Medical centre of ARENSIA Exploratory Medicine LCCKyivUkraineRecruiting
Lviv Regional Clinical HospitalLvivUkraineRecruiting
Danylo Halytsky Lviv National Medical UniversityLvivUkraineRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.