Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Ulcerative Colitis
• Age: Between 18 years - 80 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants willing and able to comply to all the study specific procedures and visits
  2. Those who will provide written informed consent
  3. Participants who have documented diagnosis (endoscopic and histological) of UC
  4. Disease severity: moderate to severe active UC
  5. Active UC extending = 15 cm from the anal verge
  6. Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications
     • 5- ASAs, such as mesalamine, sulfasalazine, olsalazine, or balsalazide
     • CS, such as prednisone (or equivalent) or budesonide (or equivalent)
     • Immunosuppressants, such as azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX)
     • Anti-tumor necrosis factor (TNF)-a agents, such as infliximab, adalimumab, or golimumab
     • Integrin inhibitor, such as vedolizumab
  7. Currently using concomitant salicylates, probiotics, or oral CS
  8. Participants of childbearing potential must have negative pregnancy test, breastfeed, or plan pregnancy during the study period, and use the acceptable contraceptive methods as per the protocol
  9. Males who are sexually active with WOCBP must agree to use the acceptable contraceptive methods as per the protocol

  
  

You may not be eligible for this study if the following are true:

• 1. Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, pseudomembranous colitis.
  2. Current or recent evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation.
  3. History or evidence of any extensive colonic resection, subtotal or total colectomy, with or without presence of a stoma or ileoanal pouch.
  4. History of diverticulitis within 60 days prior to the randomization visit
  5. Current colonic adenomas or dysplasia or past confirmed colonic dysplasia
  6. Current or recent gastrointestinal disease, including gastrointestinal surgery, that could impact the absorption of study treatment, or current or recent gastrointestinal resections.
  7. Women who are pregnant or breastfeeding.
  8. Any major illness/condition or evidence of an unstable clinical condition
  9. Any major surgery
  10. History of bleeding disorders or recent use of anti-platelet or anti-thrombotic agents
  11. Cancer or history of cancer or lymphoproliferative disease
  12. Class III or IV congestive heart failure
  13. Acute coronary syndrome and/or any history of significant cerebrovascular disease
  14. Female subjects with a breast cancer screen suspicious for malignancy
  15. Significant blood loss (> 500 mL) or blood transfusion
  16. Inability to tolerate oral medication.
  17. Inability to undergo venipuncture and/or tolerate venous access
  18. Drug or alcohol abuse,
  19. Previous exposure to BMS-986165 in any study
  20. Evidence of organ dysfunction or any clinically significant deviation
  21. Evidence of active or latent tuberculosis (TB)