CurQD + Vedolizumab for Ulcerative Colitis

(Curve UC Trial)

NL
MS
Overseen ByMiriam San Lucas
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Ryan C Ungaro
Must be taking: Corticosteroids, Methotrexate, 5-aminosalicylates
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of a new combination treatment for people with ulcerative colitis (UC), a condition that causes inflammation in the colon. Participants will receive either CurQD, a mix of curcumin and QingDai, or a placebo (inactive pill), along with vedolizumab, a medication already used for UC. The study seeks individuals who have had active UC for more than three months and experience frequent symptoms like rectal bleeding. As a Phase 4 trial, this research helps determine how the already FDA-approved and proven effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

You can continue taking your current medications if they are stable doses of certain drugs like corticosteroids, methotrexate, azathioprine, 6-mercaptopurine, oral 5-aminosalicylates, mesalamine, sulfasalazine, probiotics, or anti-diarrheal medications. However, you cannot take certain biologic therapies or calcineurin inhibitors before or during the trial.

What is the safety track record for CurQD and vedolizumab?

A previous study found CurQD, a mix of curcumin and QingDai, to be safe. Most patients experienced only minor side effects, indicating that CurQD is generally well-tolerated. Furthermore, the European Crohn's and Colitis Organisation guidelines mention CurQD, adding to its safety credibility.

Vedolizumab, in contrast, already has FDA approval for treating ulcerative colitis, meaning it has been tested and found safe for people with this condition. Together, these treatments appear to have a good safety record based on current research.12345

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for ulcerative colitis that primarily focus on suppressing inflammation, CurQD combines curcumin and QingDai to potentially offer a novel approach. Curcumin, a natural compound found in turmeric, is known for its anti-inflammatory properties, while QingDai, a traditional Chinese medicine, contributes additional anti-inflammatory effects. Researchers are excited about CurQD because it targets inflammation through these unique natural ingredients, offering a potentially safer and complementary option to existing biologics like vedolizumab. This innovative combination could lead to improved patient outcomes with fewer side effects.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Studies have shown that CurQD, a mix of curcumin and QingDai, effectively treats ulcerative colitis (UC). Clinical trials have demonstrated that this combination helps patients achieve remission, significantly improving or eliminating symptoms. In this trial, participants will receive either CurQD or a placebo. CurQD activates a part of the immune system that reduces gut inflammation, a major issue in UC. Overall, CurQD has shown promising results in managing UC symptoms.45678

Who Is on the Research Team?

RU

Ryan Ungaro, MD MS

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for people diagnosed with ulcerative colitis who are being treated with vedolizumab. Participants must meet certain health requirements and cannot join if they have conditions or factors that would interfere with the study, as determined by the researchers.

Inclusion Criteria

Understand and sign the written voluntary informed consent form prior to any protocol specific procedures
I have been taking probiotics or anti-diarrheal medicine at a stable dose for at least 2 weeks.
I am between 18 and 80 years old.
See 7 more

Exclusion Criteria

History of solid organ transplantation
Participant is pregnant, lactating, or actively trying to become pregnant
Severe lab abnormalities: hemoglobin <8.0 g/dl, albumin <3.0 g/dl, platelets <100/mcl, AST >2X ULN, ALT >2X ULN, total bilirubin >1.5X ULN
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CurQD or placebo in combination with vedolizumab for up to 30 weeks

30 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CurQD
  • Vedolizumab

Trial Overview

The study tests whether adding CurQD (a new supplement) or a placebo to standard treatment with vedolizumab helps people with ulcerative colitis. Participants are randomly assigned to receive either CurQD or a placebo along with their usual medication.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: CurQDExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ryan C Ungaro

Lead Sponsor

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37302449/

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