Combination CurQD and Vedolizumab in Ulcerative Colitis
Phase 4 · Testing CurQD and Vedolizumab · 4 sites · Ryan C Ungaro
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing CurQD (a drug) and Vedolizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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:
Plus 5 more requirement(s). There are also 28 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 160 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-10-01 (planned).
- Main results expected around 2027-06-23 (estimate from the record).
- 4 study sites listed in Israel and United States.
Groups in this study
- CurQD (listed as: experimental group)
- Placebo (listed as: placebo group)
Main thing being measured
- Number of participants with clinical remission (Week 14)
In the researchers’ words
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)..
Words you might see
- ULN: upper limit of normal: the top of the usual range for a lab test.
- Bilirubin: a yellow substance measured in blood; high levels can be a sign of liver or bile-duct problems.
- Cirrhosis: advanced scarring of the liver.
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
- JAK inhibitor: a group of oral medicines that calm parts of the immune system.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Ryan C Ungaro |
| Collaborators | United States Department of Defense |
| Enrollment | 160 (estimated) |
| Start date | 2026-10-01 |
| Primary completion (est.) | 2027-06-23 |
| First posted | 2026-06-24 |
| Last updated | 2026-10-05 |
| Official title | 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) |
| ClinicalTrials.gov ID | NCT07665294 |
Interventions
- CurQD (Drug)
Capsule doses 235mg - 385mg curcumin/150mg-300mg QingDai - Placebo (Drug)
Matching capsules - Vedolizumab (Drug)
as prescribed by participant's provider as part of routine clinical care
Full eligibility criteria (from the record)
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
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| CURVE-UC Icahn School of Medicine at Mount Sinai | New York, New York | United States | |
| Icahn School of Medicine at Mount Sinai | New York, New York | United States | |
| CURVE-UC New York Gastroenterology Associates | New York, New York | United States | |
| Sheba Medical Center | Ramat Gan | Israel |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.