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NCT06260267 Clinical Trial

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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06260267
Other study ID # 000417
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 12, 2024
Est. completion date September 15, 2025

Study information
Verified date May 2024
Source Ferring Pharmaceuticals
Contact Global Clinical Compliance
Phone +1 833-548-1402 (US/Canada)
Email DK0-Disclosure@ferring.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date September 15, 2025
Est. primary completion date September 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Microbiota suspension
Microbiota suspension
• Microbiota capsule
Microbiota capsule
• Placebo suspension
Placebo suspension
• Placebo capsule
Placebo capsule

Locations
Country Name City State
United States Ferring Investigational Site Hamden Connecticut
United States Ferring Investigational Site Jacksonville Florida
United States Ferring Investigational Site North Little Rock Arkansas
United States Ferring Investigational Site Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment-emergent adverse events from baseline to week 52 From baseline to week 52
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