Ulcerative ColitisPhase 4Curve UCNCT07665294
Combination CurQD and Vedolizumab in Ulcerative Colitis
A Phase 4 study testing CurQD and Vedolizumab in people with Ulcerative Colitis, run by Ryan C Ungaro at 4 sites in 2 countries.
Trial summary
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).. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- CurQD and Vedolizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2026to 23 Jun 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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)
Show all 28Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Miriam San Lucas contact
4 sites in 2 countries
United States3 sites
CURVE-UC Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Phyu Mar, 929-641-0917, phyu.mar@mssm.edu
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Ryan ungaro, 212-241-8100, ryan.ungaro@mssm.edu
Sari Feldman, 212-241-8100, sari.feldman@mssm.edu
CURVE-UC New York Gastroenterology Associates
New York, New York, 10128
Salitah Qureshi, salitah.qureshi@nygahealth.com
Israel1 site
Sheba Medical Center
Ramat Gan
Revital Dvir, revital.dvir@sheba.health.gov.il
About this study
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)
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)..
Read the detailed description
A prospective, 30-weeks long, treat-through, multi-center, parallel-group, double blind, placebo controlled, randomized pragmatic clinical trial to examine if there is added clinical benefit in participants with active UC receiving a combination VDZ+CurQD versus VDZ alone (with placebo). Moderately to severely active UC participants for whom VDZ was prescribed by their physician irrespective of the present trial as part of routine clinical care will be eligible. Moderate to severely active UC will be defined as a modified Mayo score of 5 to 9, with rectal bleeding score of ≥1, and with a sigmoidoscopy or colonoscopy sub-score of at least 2.
- Conditions
- Ulcerative Colitis
- Being tested
- CurQD, Placebo, Vedolizumab
- Keywords
- ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurQDDrug
Also called Curcumin-QingDai
Capsule doses 235mg - 385mg curcumin/150mg-300mg QingDai
PlaceboDrug
Matching capsules
VedolizumabDrug
as prescribed by participant's provider as part of routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| CurQD | Experimental | CurQD in 1-2 oral capsules twice a day, increasing doses up to 30 weeks.
Dose ranging from 470-1540mg curcumin and 300mg-600mg QingDai Receives: Drug: CurQD; Drug: Vedolizumab |
| Placebo | Placebo comparator | Placebo comparator in same dosing frequency Receives: Drug: Placebo; Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical remission
Clinical remission is defined as a modified Mayo score (mMS) of 2 or lower with stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic sub-score 0 or 1.
Measured: Week 14
Secondary outcomes (5)
Number of participants with a clinical response
Clinical response is defined as a decrease from baseline in the mMS of f ≥ 2 points and at least 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1.
Measured: 14 weeks
Number of participants with corticosteroid-free remission
Corticosteroid-free remission at week 30 (end of maintenance phase of clinical trial) is defined as a mMS of 2 or lower with stool frequency sub-score of 0 or 1, rectal bleeding sub-score of 0, and an endoscopic sub-score of 0 or 1 without escalation of vedolizumab therapy (increase in dosing frequency) and without corticosteroid exposure for at last 8 weeks prior to assessment.
Measured: Week 30
Number of participants with endoscopic improvement
Endoscopic improvement at weeks 14 and 30 defined as a centrally read endoscopy sub-score of 0 or 1 (score of 1 excludes friability).
The endoscopic subscore is part of the Mayo Endoscopic Score (MES). The MES endoscopic subscore is graded:
- 0. No friability or granularity, intact vascular pattern
- 1. Mild-erythema, diminished or absent vascular markings, mild granularity
- 2. Moderate-marked erythema, absent vascular marking, granularity, friability, no ulceration
- 3. Severe-marked erythema, absent vascular markings, granularity, friability, spontaneous bleeding in the lumen, ulcerations
Measured: Week 14 and Week 30
Number of participants with endoscopic remission
Endoscopic remission at weeks 14 and 30 defined as a centrally read endoscopy sub-score of 0.
The endoscopic subscore is part of the Mayo Endoscopic Score (MES). The MES endoscopic subscore is graded:
- 0. No friability or granularity, intact vascular pattern
- 1. Mild-erythema, diminished or absent vascular markings, mild granularity
- 2. Moderate-marked erythema, absent vascular marking, granularity, friability, no ulceration
- 3. Severe-marked erythema, absent vascular markings, granularity, friability, spontaneous bleeding in the lumen, ulcerations
Measured: Week 14 and Week 30
Number of participants with durable clinical remission
Durable clinical remission defined as clinical remission at both week 14 and 30.
Clinical response is defined as a decrease in the mMS of ≥ 2 points and at least 30% reduction, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1.
Measured: Week 14 and Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryan C Ungaro
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Ryan C Ungaro, Icahn School of Medicine at Mount Sinai
- Investigators
- Ryan Ungaro, MD MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665294
- Sponsor's protocol ID
- STUDY-26-00034
- Acronym
- Curve UC
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).