Under construction – not a live service
Sign in

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

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 Graz
Coordinator of this site? Confirm its status
GrazAustriaRecruiting
Sunshine Coast University
Coordinator of this site? Confirm its status
BirtinyaAustraliaRecruiting
Eastern Health
Coordinator of this site? Confirm its status
Box HillAustraliaRecruiting
Coastal Digestive Health
Coordinator of this site? Confirm its status
MaroochydoreAustraliaRecruiting
Alfred Health
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Fiona Stanley Hospital
Coordinator of this site? Confirm its status
MurdochAustraliaRecruiting
Royal Melbourne Hospital
Coordinator of this site? Confirm its status
ParkvilleAustraliaRecruiting
CHUM
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Montreal General Hospital/McGill University
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
CHUM - Pavillon R
Coordinator of this site? Confirm its status
PoličkaCzechiaRecruiting
The Specialty Hospital (TSH) / Advanced Clinical Center
Coordinator of this site? Confirm its status
AmmanJordanRecruiting
Jordan University Hospital
Coordinator of this site? Confirm its status
AmmanJordanRecruiting
Irbid Specialty Hospital
Coordinator of this site? Confirm its status
IrbidJordanRecruiting
The Hospital of Lithuanian University of Health Sciences
Coordinator of this site? Confirm its status
KaunasLithuaniaRecruiting
IMSP Spitalul Clinic Republican Timofei Moneaga
Coordinator of this site? Confirm its status
ChisinauMoldovaRecruiting
PCRN Auckland
Coordinator of this site? Confirm its status
AucklandNew ZealandRecruiting
PCRN Christchurch
Coordinator of this site? Confirm its status
ChristchurchNew ZealandRecruiting
PCRN Waikato
Coordinator of this site? Confirm its status
HamiltonNew ZealandRecruiting
PCRN Tasman
Coordinator of this site? Confirm its status
NelsonNew ZealandRecruiting
PCRN Wellington
Coordinator of this site? Confirm its status
Upper HuttNew ZealandRecruiting
Centrum Medyczne
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Centrum Medyczne Lukamed
Coordinator of this site? Confirm its status
ChojnicePolandRecruiting
Vita Longa Sp. Z o.o.
Coordinator of this site? Confirm its status
KatowicePolandRecruiting
Centrum Medyczne Medyk
Coordinator of this site? Confirm its status
RzeszówPolandRecruiting
Endoskopia Sp z o.o.
Coordinator of this site? Confirm its status
SopotPolandRecruiting
Nowe zdrowie-CK, Kiełtucki
Coordinator of this site? Confirm its status
StaszówPolandRecruiting
Medical Network Company
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Penta Hospitals Przychodnie
Coordinator of this site? Confirm its status
WroclawPolandRecruiting
Regional Clinical Hospital
Coordinator of this site? Confirm its status
Ivano-FrankivskUkraineRecruiting
Medical centre of ARENSIA Exploratory Medicine LCC
Coordinator of this site? Confirm its status
KyivUkraineRecruiting
Lviv Regional Clinical Hospital
Coordinator of this site? Confirm its status
LvivUkraineRecruiting
Danylo Halytsky Lviv National Medical University
Coordinator of this site? Confirm its status
LvivUkraineRecruiting

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