Study Stopped
Not due to safety concerns, but changes in strategy which this trial no longer fulfills.
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
1 other identifier
interventional
N/A
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2024
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedStudy Start
First participant enrolled
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2026
CompletedOctober 18, 2024
October 1, 2024
1.8 years
February 7, 2024
October 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-emergent adverse events from baseline to week 52
From baseline to week 52
Study Arms (4)
FE 999322
EXPERIMENTALMicrobiota suspension
FE 999324
EXPERIMENTALMicrobiota capsule
Placebo FE 999322
PLACEBO COMPARATORPlacebo suspension
Placebo FE 999324
PLACEBO COMPARATORPlacebo capsule
Interventions
Eligibility Criteria
You may qualify if:
- Subject aged ≥18 at screening
- Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ferring Investigational Site
North Little Rock, Arkansas, 72117, United States
Ferring Investigational Site
Hamden, Connecticut, 06518, United States
Ferring Investigational Site
Inverness, Florida, 34452, United States
Ferring Investigational Site
Jacksonville, Florida, 32256, United States
Ferring Investigational Site
Orange City, Florida, 32763, United States
Ferring Investigational Site
Glenview, Illinois, 60026, United States
Ferring Investigational Site
Gurnee, Illinois, 60031, United States
Ferring Investigational Site
Shreveport, Louisiana, 71105, United States
Ferring Investigational Site
Boston, Massachusetts, 02115, United States
Ferring Investigational Site
Oklahoma City, Oklahoma, 73102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2024
First Posted
February 15, 2024
Study Start
March 12, 2024
Primary Completion
January 15, 2026
Study Completion
January 15, 2026
Last Updated
October 18, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share