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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OD-07656 Dosing Regimen 1 | Experimental | Open Label, Oral, twice daily dose |
|
| OD-07656 Dosing Regimen 2 | Experimental | Randomized, Oral, twice daily dose |
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| OD-07656 Dosing Regimen 3 | Experimental | Randomized, Oral, twice daily dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OD-07656 | Drug | Experimental intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656 | 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. | Baseline and 12 weeks |
| Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve clinical remission | 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. | Baseline and 12 weeks |
| Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Contact | 857-393-6160 | clinicaltrials@odysseytx.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Odyssey Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunshine Coast University | Recruiting | Birtinya | Australia |
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| Vedolizumab | Drug | Active standard of care comparator |
|
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. |
| Baseline and 50 weeks |
| Eastern Health | Recruiting | Box Hill | Australia |
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| Coastal Digestive Health | Recruiting | Maroochydore | Australia |
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| Alfred Health | Recruiting | Melbourne | 3004 | Australia |
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| Fiona Stanley Hospital | Recruiting | Murdoch | 6150 | Australia |
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| Royal Melbourne Hospital | Recruiting | Parkville | Australia |
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| Medical University of Graz | Recruiting | Graz | Austria |
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| CHUM | Recruiting | Montreal | H2X OA9 | Canada |
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| Montreal General Hospital/McGill University | Recruiting | Montreal | Canada |
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| CHUM - Pavillon R | Recruiting | Polička | 1549 | Czechia |
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| Jordan University Hospital | Recruiting | Amman | 11942 | Jordan |
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| The Specialty Hospital (TSH) / Advanced Clinical Center | Recruiting | Amman | Jordan |
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| Irbid Specialty Hospital | Recruiting | Irbid | 21110 | Jordan |
|
| The Hospital of Lithuanian University of Health Sciences | Recruiting | Kaunas | Lithuania |
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| IMSP Spitalul Clinic Republican Timofei Moneaga | Recruiting | Chisinau | Md-2025 | Moldova |
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| PCRN Auckland | Recruiting | Auckland | 0622 | New Zealand |
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| PCRN Christchurch | Recruiting | Christchurch | 0622 | New Zealand |
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| PCRN Waikato | Recruiting | Hamilton | 3200 | New Zealand |
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| PCRN Tasman | Recruiting | Nelson | 7011 | New Zealand |
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| PCRN Wellington | Recruiting | Upper Hutt | 5018 | New Zealand |
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| Centrum Medyczne | Recruiting | Bydgoszcz | Poland |
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| Centrum Medyczne LukaMed | Recruiting | Chojnice | Poland |
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| Vita Longa Sp. z.o.o. | Recruiting | Katowice | Poland |
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| Centrum Medyczne Medyk | Recruiting | Rzeszów | Poland |
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| Endoskopia Sp. z.o.o | Recruiting | Sopot | Poland |
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| Nowe zdrowie-CK, Kiełtucki | Recruiting | Staszów | Poland |
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| Medical Network Company | Recruiting | Warsaw | Poland |
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| Penta Hospitals Przychodnie | Recruiting | Wroclaw | 54-239 | Poland |
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| Regional Clinical Hospital | Recruiting | Ivano-Frankivsk | 76008 | Ukraine |
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| Medical centre of ARENSIA Exploratory Medicine LCC | Recruiting | Kyiv | 01135 | Ukraine |
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| Danylo Halytsky Lviv National Medical University | Recruiting | Lviv | 79000 | Ukraine |
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| Lviv Regional Clinical Hospital | Recruiting | Lviv | 79010 | Ukraine |
|
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
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