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Combination CurQD and Vedolizumab in Ulcerative Colitis

ConditionUlcerative Colitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRyan C Ungaro

About this trial

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)..

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: CurQDExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
Week 14

Secondary outcomes

1

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.

Time frame
14 weeks
2

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.

Time frame
Week 30
3

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

Time frame
Week 14 and Week 30
4

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

Time frame
Week 14 and Week 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ryan C Ungaro

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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