Combination CurQD and Vedolizumab in Ulcerative Colitis (Curve UC)

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)..

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: CurQD; Drug: Vedolizumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nicole Lewis; Phone Number: 212-468-2174; Email: nicole.lewis@mssm.edu
• Study Contact Backup: Name: Miriam San Lucas; Email: Miriam.sanlucas@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CurQD; 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	Drug: CurQD; Capsule doses 235mg - 385mg curcumin/150mg-300mg QingDai; Other Names: Curcumin-QingDai; Drug: Vedolizumab; as prescribed by participant's provider as part of routine clinical care
Placebo Comparator: Placebo; Placebo comparator in same dosing frequency	Drug: Placebo; Matching capsules; Drug: Vedolizumab; as prescribed by participant's provider as part of routine clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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.	Week 14 and Week 30

Collaborators and Investigators

• Sponsor: Ryan C Ungaro
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ryan Ungaro, MD MS, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ulcerative colitis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; vedolizumab
• Other Study ID Numbers: STUDY-26-00034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

To achieve aims in the approved proposal. Proposals should be directed to ryan.ungaro@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No