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

Phase 1

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Drug: Placebo capsule; Drug: Microbiota capsule; Drug: Microbiota suspension; Drug: Placebo suspension

• Registration Number: NCT06260267
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-03-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo FE 999324	Placebo capsule	Placebo capsule
FE 999324	Microbiota capsule	Microbiota capsule
FE 999322	Microbiota suspension	Microbiota suspension
Placebo FE 999322	Placebo suspension	Placebo suspension

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events from baseline to week 52	From baseline to week 52

Trial Locations

Locations (1)

Ferring Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States