A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis

Ferring Pharmaceuticals

Overview

To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Ulcerative Colitis

Interventions

Microbiota suspensionDRUG

Microbiota suspension

Microbiota capsuleDRUG

Microbiota capsule

Placebo suspensionDRUG

Placebo suspension

Placebo capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject aged ≥18 at screening * Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening Exclusion Criteria: * Active disease or history of Crohn's disease * Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC * Active gastrointestinal infection.

Locations (10)

Ferring Investigational Site

North Little Rock, Arkansas, United States

Ferring Investigational Site

Hamden, Connecticut, United States

Ferring Investigational Site

Inverness, Florida, United States

Outcomes

Primary Outcomes

Treatment-emergent adverse events from baseline to week 52

Time frame: From baseline to week 52

Data from ClinicalTrials.gov

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