Not yet recruitingPhase 4

Combination CurQD and Vedolizumab in Ulcerative Colitis

CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well CurQD works and how safe it is when taken with vedolizumab, a usual treatment for ulcerative colitis (UC). UC causes swelling and sores in the large bowel. Adults ages 18 to 80 with active UC will receive either CurQD or a placebo (a pill with no active medicine) along with vedolizumab.

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)..

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 80 years old and understand and sign the study consent form.
  • Have had UC for more than 3 months.
  • Have active UC with rectal bleeding and bowel swelling that meet the study’s test scores.
  • Have UC that extends at least 5 centimeters into the bowel from the anus.
  • If taking oral steroids, have a steady dose for more than 2 weeks before screening, within the study’s dose limits.
  • If taking methotrexate, azathioprine, 6-MP, or oral medicines such as mesalamine or sulfasalazine, have a steady dose for more than 4 weeks before screening and through the study.
  • If taking probiotics or diarrhea medicines, have a steady dose for at least 2 weeks before screening and through the study.
  • If you have had UC for 8 years or longer, be up to date on colon cancer screening before assignment to a study group.

Who can't join

  • Have Crohn’s colitis or bowel inflammation that has not been clearly classified; have had colon removal or bowel pouch surgery; or have very severe UC, a dangerously swollen colon, or a UC hospital stay now or within the past 2 weeks.
  • Have used vedolizumab or etrolizumab before, or more than one advanced UC drug; take or plan to take another advanced UC drug with vedolizumab; recently used cyclosporine or tacrolimus; or took more than 20 mg of prednisone daily within 2 weeks before joining.
  • Have hepatitis B or C, HIV, any active infection, a positive stool test for infection, or tuberculosis that has not been adequately treated.
  • Have severe blood test problems, reduced kidney function, long-term liver disease, or a history of primary sclerosing cholangitis (scarring of the bile ducts).
  • Have a history of colon cancer or untreated abnormal colon cells, or cancer or certain immune-cell disorders within the past 5 years. Some fully treated cervical and skin cancers are allowed.
  • Have another serious illness that could make joining unsafe, have had an organ transplant, or currently need all nutrition through a vein.
  • Have had a blood clot in a deep vein or lung, have a disorder that makes blood clot too easily, or take blood-thinning medicine other than aspirin.
  • Are pregnant, breastfeeding, or actively trying to become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * Participant will have a minimum disease extent of at least 5 cm proximal from the anal verge * Subjects must be on stable doses of concomitant medications, defined as: * Participants on oral corticosteroids must be on a stable dose \>2 weeks (dose not exceeding 20 mg/day prednisone, 9mg/day of budesonide, or equivalent) prior to screening * Participants on methotrexate (MTX), azathioprine (AZA), or 6-mercaptopurine (6-MP) must be on treatment at a stable dose \>4 weeks prior to screening and until end of study * Participants on oral 5-aminosalicylates, mesalamine, or sulfasalazine must be on a stable dose for \>4 weeks prior to screening and until end of study * Probiotics or anti-diarrheal at a stable dose ≥ 2 weeks prior to Screening and until the end of study * Participants who have been diagnosed with UC for ≥8 years must be up to date on their colorectal cancer screening per local guidelines by the time of randomization. Exclusion Criteria: * 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 * Receiving or planned concomitant biologic or small targeted small molecule advanced therapy (tumor necrosis factor antagonist, interleukin \[IL\]-12/23 antagonist, IL-23 antagonist, Janus kinase \[JAK\] inhibitor and/or sphingosine-1-phosphate \[S1P\] receptor modulator) with vedolizumab * Any calcineurin inhibitor use within 4 weeks prior to screening (e.g., cyclosporine, tacrolimus) * Participant with known hepatitis B or C infection * Participant with active or latent tuberculosis (that has not been adequately treated) * Participant has any active infection * Participant has fecal sample positive for enteric infection at screening * History of prior colectomy or ileal pouch anal anastomosis * Participants with fulminant UC, toxic megacolon, or hospitalized for UC currently or within prior 2 weeks * Severe lab abnormalities including hemoglobin \< 8.0 g/dl, albumin \< 3.0 g/dl, platelets \< 100/mcl, AST \> 2X upper limit of normal (ULN), ALT \>2X ULN, total bilirubin \>1.5X ULN * Participant with history of colon cancer or colonic dysplasia not adequately treated (i.e. polyp removed) * Any serious underlying disease other than UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as any unstable or uncontrolled medical disorder, class III or IV congestive heart failure, demyelinating disease) * History of primary sclerosing cholangitis * Renal impairment and reduced creatinine clearance defined as estimated glomerular filtration rate GFR (eGFR)\<60mL/min * History of chronic liver disease (autoimmune hepatitis, cirrhosis, etc.) * Currently requiring total parental nutrition * History of solid organ transplantation * History of malignancy or lymphoproliferative disorder in the prior 5 years, other than * adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous * cell carcinoma, or nonmetastatic basal cell carcinoma of the skin. * History of venothromboembolism (DVT or PE) or known inherited or acquired hyper coagulation disorder * Currently taking anti-platelet agent (other than aspirin) or anti-coagulant (coumadin, * rivaroxaban, etc.) * History of human immunodeficiency virus (HIV) infection * Participant is pregnant or lactating or actively trying to become pregnant

Study sites (3)

NY