VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Overview

Información sobre este estudio

The purpose of this study is to evaluate the safety, effectovemess, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/28/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Darrell Pardi, M.D.

Abierto para la inscripción

Contact information:

Patricia Kammer CCRP

(507) 538-1827

Kammer.Patricia@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20558431

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