VE202 for Ulcerative Colitis

No longer recruiting at 80 trial locations

Overseen By Azadeh Haghighi, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vedanta Biosciences, Inc.

Must not be taking: Probiotics, Herbal preparations

Disqualifiers: Crohn's disease, Indeterminate colitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VE202 (also known as JNJ 67670187) for individuals with mild to moderate ulcerative colitis, a condition that inflames the colon. The study aims to determine the safety and effectiveness of VE202 and its impact on the gut's microbiota (the community of bacteria in the intestines). Participants will be divided into two groups: one will begin with the active treatment, while the other will start with a placebo before switching. Those who have had ulcerative colitis for at least three months and have not used certain advanced medications may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that any corticosteroid doses be stable for at least 4 weeks and other UC medication doses be stable for at least 8 weeks before joining. You cannot use probiotics or certain herbal medicines within 2 weeks before starting the trial.

Is there any evidence suggesting that VE202 is likely to be safe for humans?

Research has shown that VE202 is generally safe and well tolerated. Earlier studies reported no serious side effects linked to the treatment, and it did not raise new safety concerns for people with mild to moderate ulcerative colitis. Although VE202 was not more effective than a placebo in these studies, its safety remains reassuring. Participants did not experience harmful effects from the treatment itself. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike the standard treatments for ulcerative colitis, which often involve anti-inflammatory drugs, immunosuppressants, or biologics, VE202 is a novel approach that targets the gut microbiome. Researchers are excited about VE202 because it uses live bacterial strains to potentially restore a healthy microbiome balance, offering a new mechanism of action. This could lead to more personalized and potentially more effective treatment outcomes with fewer side effects compared to traditional therapies.

What evidence suggests that VE202 might be an effective treatment for ulcerative colitis?

Research has shown that VE202, a treatment for ulcerative colitis, did not outperform a placebo in past studies. It failed to achieve the primary goal of reducing symptoms more effectively than a placebo. VE202 consists of a pill containing 16 types of beneficial bacteria. Although the treatment was safe, it did not alleviate ulcerative colitis symptoms as anticipated. This trial will further investigate VE202, with participants in Group A receiving VE202 initially and Group B receiving it later, to assess its safety and potential effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with mild to moderate ulcerative colitis (UC) diagnosed at least 3 months ago. Participants must not have received certain UC treatments like biologics, and doses of other UC meds should be stable for 8 weeks. Exclusions include a history of Crohn's disease, allergies to VE202 or vancomycin, recent non-IBD diarrheal illnesses, use of probiotics or herbal preparations within 2 weeks before the trial, past fecal transplantations within 6 months, and any intestinal surgery except cholecystectomy or appendectomy.

Inclusion Criteria

I was diagnosed with ulcerative colitis over 3 months ago.

My corticosteroid dose has been the same for at least 4 weeks.

My ulcerative colitis medication doses have been stable for 8 weeks.

Exclusion Criteria

Allergy to VE202 or any of its components

Allergy to vancomycin or any of its components

I haven't taken probiotics or herbal medicines in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive VE202 or placebo for 8 weeks with Vancomycin pretreatment

8 weeks

Treatment Part 2

Participants receive VE202 or placebo for 2 weeks with Vancomycin pretreatment

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VE202

Trial Overview The Phase 2 study tests the safety and effectiveness of VE202 in patients with mild to moderate UC. It also looks at how it affects gut microbiota. Patients will receive either VE202 with a placebo that mimics vancomycin or vice versa; some may get both placebos as controls.

How Is the Trial Designed?

Group I: Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. Experimental Treatment 4 Interventions

In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks. In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Group II: Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. Experimental Treatment 4 Interventions

In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks. In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Who Is Running the Clinical Trial?

Vedanta Biosciences, Inc.

Lead Sponsor

Trials

7

Recruited

1,200+

Citations

1. vedantabio.com vedantabio.com/press-release/vedanta-biosciences-announces-phase-2-study-of-ve202-in-ulcerative-colitis-did-not-meet-primary-endpoint/

Vedanta Biosciences Announces Phase 2 Study of VE202 ... Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint ... efficacy with a 30.5% absolute ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05370885

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed. VE202 in ...

3. synapse.patsnap.com synapse.patsnap.com/drug/1fb685bb89f84c16af0a3d32e6f4c385

VE-202 - Drug Targets, Indications, Patents Participants received either VE202 or placebo alongside stable background ulcerative colitis therapy for eight weeks. The primary endpoint — an endoscopic ...

4. vedantabio.com vedantabio.com/pipeline-programs/ve202/

VE202 VE202 is a wholly-owned, orally-administered defined bacterial consortium candidate consisting of 16 strains of live commensal bacteria for the treatment of IBD ...

5. adisinsight.springer.com adisinsight.springer.com/drugs/800040875

VE 202 - AdisInsight - Springer VE 202, an orally-administered live biotherapeutic product (LBP), is being developed by Vedanta Biosciences (an affiliate of PureTech Health) for the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05370885?term=ve202&rank=1

Study Details | NCT05370885 | VE202 in Patients With Mild ... Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed. VE202 in ...