CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study

November 19, 2025 updated by: Evinature Ltd.

Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study

This study aims to evaluate whether adding CurQD, a nutraceutical composed of Curcumin and QingDai, improves treatment outcomes in patients with active ulcerative colitis (UC) who are already receiving Vedolizumab but still have ongoing disease activity. The study will use de-identified patient records collected through Evinature's global data platform. We will examine whether the addition of CurQD helps patients stay on Vedolizumab longer, improves symptoms and biomarkers, and increases satisfaction with treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Curcumin and QingDai, (Indigo, QD) are two herbal traditional medicine compounds which have been investigated for their use in mild-moderate and moderate-severe UC, respectively. A combination of Curcumin and QD (CurQD), which was developed at Sheba Medical Center to maximize clinical efficacy while reducing long-term high-dose QD exposure, has been used in clinical practice in Israel since 2015 and has gained wide acceptance by UC patients and IBD experts [1,2]. In two multi-center retrospective studies, CurQD was found effective in inducing clinical and biomarker remission in both adult and pediatric patients, including in patients who were refractory to biologic and/or small molecules [3,4], and recent evidence from a pediatric cohort in the U.S also documented intestinal sonographic response to CurQD [5]. In a placebo-controlled randomized trial from Israel and Greece, CurQD was found superior to placebo in inducing and maintaining clinical and endoscopic remission without any safety signals [6,7]. Moreover, the study also showed the active compounds in CurQD exerts agonistic up-regulation of Aryl-hydrocarbon Receptor pathway in the rectal mucosa [6], supporting its unique non-immunosuppressive mode-of-action. Subsequently, CurQD has been increasingly used by IBD experts in academic centers in the USA and elsewhere as Add-on therapy in patients with partial or non-response to biologics and/or small molecules medications. Recently, CurQD became the first and only nutraceutical to date to pass the CCFA Ingestible committee examination of supporting clinical and scientific data to allow its endorsement by the CCFA. Collectively, these data provide the rationale for exploring large scale population-based impact of combining CurQD with a biologic.

The present retrospective cohort study will interrogate the Evinature GDPR HIPAA compliant database to identify patients who started CurQD while being treated with VDZ. The study will investigate the clinical benefit of adding CurQD in combination with VDZ, in patients partially responding or not-responding to VDZ.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Binyamina, Israel
        • Evinature

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will comprise adult and pediatric (age > 8 years-old) UC patients with active disease while on VDZ treatment who start CurQD combo therapy concomitantly with VDZ

Description

Inclusion Criteria:

  • Age >8 years
  • Diagnosis of ulcerative colitis (self-reported)
  • Completed Evinature clinical assessment between April 1, 2022, and cutoff date
  • Vedolizumab treatment at baseline
  • Active disease at entry (SCCAI ≥3 or PRO-2 ≥2 with RB ≥1)
  • Initiated CurQD at entry

Exclusion Criteria:

  • Vedolizumab for indications other than UC
  • Unclear medication status at baseline
  • Not active disease when starting CurQD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1 (VDZ + CurQD)
Patients with ulcerative colitis on Vedolizumab who initiated CurQD as adjunct therapy.
Dietary supplement: CurQD (Curcumin + QingDai combination)
Patients received CurQD in addition to Vedolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD
Time Frame: Week 12
Count of participants who remain on vedolizumab (VDZ) at Week 12 after initiating adjunct CurQD. Baseline clinical activity is defined as SCCAI ≥3 or PRO-2 ≥2 with rectal bleeding ≥1. Percentages will also be calculated relative to the number of participants with Week 12 data.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Retaining Vedolizumab at Week 30
Time Frame: Week 30
Count of participants with ≥30 weeks of follow-up who remain on VDZ at Week 30 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 30 data.
Week 30
Number of Participants Retaining Vedolizumab at Week 54
Time Frame: Week 54
Count of participants with ≥54 weeks of follow-up who remain on VDZ at Week 54 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 54 data
Week 54
Number of Participants Achieving Clinical Remission at Week 12
Time Frame: Week 12
Clinical response is defined as SCCAI decrease ≥3, or PRO-2 decrease ≥2 with RB = 0 and SF ≤1, among participants with available baseline and follow-up values. Percentages will also be calculated relative to the number of participants with Week 12 clinical data.
Week 12
Number of Participants Achieving Clinical Response at Week 54
Time Frame: Week 54
Same response definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data.
Week 54
Number of Participants in Clinical Remission at Week 12
Time Frame: Week 12
Clinical remission defined as SCCAI ≤2 or PRO-2 = 0. Percentages will also be calculated relative to the number of participants with Week 12 clinical data.
Week 12
Number of Participants in Clinical Remission at Week 54
Time Frame: Week 54
Same remission definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data.
Week 54
Number of Participants Reporting Satisfaction with CurQD + Vedolizumab (VAS 1-10)
Time Frame: Week 12
Number of participants providing a satisfaction score using a 1-10 Visual Analog Scale (VAS) after using CurQD + VDZ. Percentages will also be calculated relative to the number of participants who completed the VAS assessment.
Week 12
Number of Participants Achieving Fecal Calprotectin (FCP) Response
Time Frame: Up to Week 54
FCP response defined as ≥50% reduction from baseline among participants with baseline FCP ≥250 mcg/g and available follow-up FCP. Percentages will also be calculated relative to the number of participants with FCP measurements.
Up to Week 54
Number of Participants Achieving Fecal Calprotectin (FCP) Remission
Time Frame: Up to Week 54
FCP remission defined as FCP <150 mcg/g among participants with baseline FCP ≥250 mcg/g, following STRIDE II and GEMINI-I guidance. Percentages will also be calculated relative to the number of participants with FCP measurements.
Up to Week 54
Number of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: Baseline through Week 54
Number and type of adverse events occurring during combined CurQD + VDZ therapy. Percentages will also be calculated relative to the number of participants exposed to both therapies.
Baseline through Week 54
Sensitivity Analysis: Number of Participants Retaining Vedolizumab at Week 12 with Baseline SCCAI ≥6
Time Frame: Week 12
Same definition as the primary endpoint but limited to participants with moderate-severe disease (baseline SCCAI ≥6). Percentages will also be calculated relative to the number of participants in this subgroup with Week 12 data.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evinature Ltd.

Collaborators

Sheba Medical Center
Takeda Pharmaceuticals U.S.A., Inc.

Investigators

  • Study Director: Shomron Ben-Horin, Evinature Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2025

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

August 20, 2026

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR-2024-200598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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