Combination CurQD and Vedolizumab in Ulcerative Colitis
ConditionUlcerative Colitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRyan C Ungaro
About this trial
The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..
Eligibility criteria
Qualifiers
Age 18 to 80 years old (inclusive) at time of consent
Understand and sign the written voluntary informed consent form prior to any protocol specific procedures
History of established UC for >3 months as determined by standard clinical criteria
Active UC defined as a modified Mayo score of 5-9 with a rectal bleeding sub score [RBS] ≥1 and Mayo endoscopic score [MES] ≥2
Disqualifiers
Diagnosis of inflammatory bowel disease unclassified (IBD-U) or Crohn's colitis
Previously received VDZ or etrolizumab (another anti-integrin biologic therapy)
Receiving corticosteroids at a dose >20mg/day of prednisone within two weeks prior to enrollment
Participants who have been exposed to more than one advanced therapy medication (biologic or small molecule drug) before enrollment will be excluded
Trial design
Treatments tested in this trial
- CurQD
- Placebo
- Vedolizumab
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ryan C Ungaro
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov