VE202 in Patients with Mild-to-Moderate Ulcerative Colitis

Vedanta Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Colitis, Ulcerative; Ulcerative Colitis

Treatments: Other: Vancomycin Placebo; Drug: Vancomycin Oral Capsule; Biological: VE202; Other: VE202 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05370885

VE202-002

2021-001280-24 (EudraCT Number)

Details and patient eligibility

About

A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

Full description

A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

KEY INCLUSION CRITERIA

1. 18 to 75 years of age

2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization

3. Active mild to moderate UC, as defined by the following:

   1. Disease that extends at least 15 cm from the anal verge
   2. A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1

4. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC

5. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization

6. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization

KEY EXCLUSION CRITERIA

1. Known history of Crohn's disease (CD) or indeterminate colitis
2. A known diagnosis of primary sclerosing cholangitis
3. Allergy to VE202 or any of its components
4. Allergy to vancomycin or any of its components
5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.

Other group

Description:

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.

Treatment:

Other: VE202 Placebo

Biological: VE202

Drug: Vancomycin Oral Capsule

Other: Vancomycin Placebo

Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

Other group

Description:

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.

Treatment:

Other: VE202 Placebo

Biological: VE202

Drug: Vancomycin Oral Capsule

Other: Vancomycin Placebo