Combination CurQD and Vedolizumab in Ulcerative Colitis

NCT07665294 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY-26-00034
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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)..

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of participants with a clinical response

  14 weeks

• Number of participants with corticosteroid-free remission

  Week 30

• Number of participants with endoscopic improvement

  Week 14 and Week 30

• Number of participants with endoscopic remission

  Week 14 and Week 30

• Number of participants with durable clinical remission

  Week 14 and Week 30

Study Arms (2)

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

Drug: CurQD; Drug: Vedolizumab

Placebo

PLACEBO COMPARATOR

Placebo comparator in same dosing frequency

Drug: Placebo; Drug: Vedolizumab

Interventions

Placebo DRUG

Matching capsules

Placebo

Vedolizumab DRUG

as prescribed by participant's provider as part of routine clinical care

CurQD; Placebo

CurQD DRUG

Capsule doses 235mg - 385mg curcumin/150mg-300mg QingDai

Also known as: Curcumin-QingDai

CurQD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ryan C Ungaro: lead
• United States Department of Defense: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ryan Ungaro, MD MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Lewis

CONTACT

212-468-2174; nicole.lewis@mssm.edu

Miriam San Lucas

CONTACT

Miriam.sanlucas@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (1)