- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260267
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
April 3, 2024 updated by: Ferring Pharmaceuticals
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Global Clinical Compliance
- Phone Number: +1 833-548-1402 (US/Canada)
- Email: DK0-Disclosure@ferring.com
Study Contact Backup
- Name: Global Clinical Compliance
- Phone Number: +1 862-286-5200 (outside US)
- Email: DK0-Disclosure@ferring.com
Study Locations
-
-
Arkansas
-
North Little Rock, Arkansas, United States, 72117
- Recruiting
- Ferring Investigational Site
-
Contact:
- Global Clinical Compliance
-
-
Florida
-
Jacksonville, Florida, United States, 32256
- Recruiting
- Ferring Investigational Site
-
Contact:
- Global Clinical Compliance
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73102
- Recruiting
- Ferring Investigational Site
-
Contact:
- Global Clinical Compliance
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FE 999322
Microbiota suspension
|
Microbiota suspension
|
Experimental: FE 999324
Microbiota capsule
|
Microbiota capsule
|
Placebo Comparator: Placebo FE 999322
Placebo suspension
|
Placebo suspension
|
Placebo Comparator: Placebo FE 999324
Placebo capsule
|
Placebo capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment-emergent adverse events from baseline to week 52
Time Frame: From baseline to week 52
|
From baseline to week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Global Clinical Compliance, Ferring Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2024
Primary Completion (Estimated)
September 15, 2025
Study Completion (Estimated)
September 15, 2025
Study Registration Dates
First Submitted
February 7, 2024
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 15, 2024
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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