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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2026-01-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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FE 999322

Microbiota suspension

Group Type EXPERIMENTAL

Microbiota suspension

Intervention Type DRUG

Microbiota suspension

FE 999324

Microbiota capsule

Group Type EXPERIMENTAL

Microbiota capsule

Intervention Type DRUG

Microbiota capsule

Placebo FE 999322

Placebo suspension

Group Type PLACEBO_COMPARATOR

Placebo suspension

Intervention Type DRUG

Placebo suspension

Placebo FE 999324

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DRUG

Placebo capsule

Interventions

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Microbiota suspension

Intervention Type DRUG

Microbiota capsule

Intervention Type DRUG

Placebo suspension

Intervention Type DRUG

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No