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RecruitingPhase 2NCT06850727

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

Sponsor

Odyssey Therapeutics

Enrollment

57 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)UC - Ulcerative Colitis

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called OD-07656 followed by vedolizumab (an approved treatment for inflammatory bowel disease) in patients with moderately to severely active ulcerative colitis (UC) — a chronic inflammation of the large bowel — who have not responded well to standard therapies. **You may be eligible if...** - You have a confirmed diagnosis of ulcerative colitis - Your UC is moderately to severely active, as measured by a standard scoring system (Modified Mayo Score) - You have tried and failed, lost response to, or cannot tolerate at least one standard UC therapy (such as aminosalicylates, steroids, immunosuppressants, biologics, or JAK inhibitors) **You may NOT be eligible if...** - You have Crohn's disease or indeterminate colitis - You have very mild or well-controlled UC - You have a serious active infection or have recently been hospitalized for UC complications - You have had surgery on your large bowel Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOD-07656

Experimental intervention

DRUGVedolizumab

Active standard of care comparator

Locations(32)

Sunshine Coast University

Birtinya, Australia

Eastern Health

Box Hill, Australia

Coastal Digestive Health

Maroochydore, Australia

Alfred Health

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Royal Melbourne Hospital

Parkville, Australia

Medical University of Graz

Graz, Austria

CHUM

Montreal, Canada

Montreal General Hospital/McGill University

Montreal, Canada

CHUM - Pavillon R

Polička, Czechia

Jordan University Hospital

Amman, Jordan

The Specialty Hospital (TSH) / Advanced Clinical Center

Amman, Jordan

Irbid Specialty Hospital

Irbid, Jordan

The Hospital of Lithuanian University of Health Sciences

Kaunas, Lithuania

IMSP Spitalul Clinic Republican Timofei Moneaga

Chisinau, Moldova

PCRN Auckland

Auckland, New Zealand

PCRN Christchurch

Christchurch, New Zealand

PCRN Waikato

Hamilton, New Zealand

PCRN Tasman

Nelson, New Zealand

PCRN Wellington

Upper Hutt, New Zealand

Centrum Medyczne

Bydgoszcz, Poland

Centrum Medyczne LukaMed

Chojnice, Poland

Vita Longa Sp. z.o.o.

Katowice, Poland

Centrum Medyczne Medyk

Rzeszów, Poland

Endoskopia Sp. z.o.o

Sopot, Poland

Nowe zdrowie-CK, Kiełtucki

Staszów, Poland

Medical Network Company

Warsaw, Poland

Penta Hospitals Przychodnie

Wroclaw, Poland

Regional Clinical Hospital

Ivano-Frankivsk, Ukraine

Medical centre of ARENSIA Exploratory Medicine LCC

Kyiv, Ukraine

Danylo Halytsky Lviv National Medical University

Lviv, Ukraine

Lviv Regional Clinical Hospital

Lviv, Ukraine

View Full Details on ClinicalTrials.gov

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NCT06850727

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