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
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
Australia
Sunshine Coast University
RECRUITING
Birtinya
Eastern Health
RECRUITING
Box Hill
Coastal Digestive Health
RECRUITING
Maroochydore
Alfred Health
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Royal Melbourne Hospital
RECRUITING
Parkville
Austria
Medical University of Graz
RECRUITING
Graz
Canada
CHUM
RECRUITING
Montreal
Montreal General Hospital/McGill University
RECRUITING
Montreal
Jordan
Jordan University Hospital
RECRUITING
Amman
The Specialty Hospital (TSH) / Advanced Clinical Center
RECRUITING
Amman
Irbid Specialty Hospital
RECRUITING
Irbid
Lithuania
The Hospital of Lithuanian University of Health Sciences
RECRUITING
Kaunas
New Zealand
PCRN Auckland
RECRUITING
Auckland
PCRN Christchurch
RECRUITING
Christchurch
PCRN Waikato
RECRUITING
Hamilton
PCRN Tasman
RECRUITING
Nelson
PCRN Wellington
RECRUITING
Upper Hutt
Poland
Centrum Medyczne
RECRUITING
Bydgoszcz
Centrum Medyczne LukaMed
RECRUITING
Chojnice
Vita Longa Sp. z.o.o.
RECRUITING
Katowice
Centrum Medyczne Medyk
RECRUITING
Rzeszów
Endoskopia Sp. z.o.o
RECRUITING
Sopot
Nowe zdrowie-CK, Kiełtucki
RECRUITING
Staszów
Medical Network Company
RECRUITING
Warsaw
Penta Hospitals Przychodnie
RECRUITING
Wroclaw
Republic of Moldova
IMSP Spitalul Clinic Republican Timofei Moneaga
RECRUITING
Chisinau
Ukraine
Regional Clinical Hospital
RECRUITING
Ivano-frankivsk
Medical centre of ARENSIA Exploratory Medicine LCC