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

October 16, 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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Ferring Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Ferring Investigational Site
    • Florida
      • Inverness, Florida, United States, 34452
        • Ferring Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Ferring Investigational Site
      • Orange City, Florida, United States, 32763
        • Ferring Investigational Site
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Ferring Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Ferring Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Ferring Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Ferring Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Ferring Investigational Site

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
Drug: Microbiota suspension
Microbiota suspension
Experimental: FE 999324
Microbiota capsule
Drug: Microbiota capsule
Microbiota capsule
Placebo Comparator: Placebo FE 999322
Placebo suspension
Drug: Placebo suspension
Placebo suspension
Placebo Comparator: Placebo FE 999324
Placebo capsule
Drug: 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

Ferring Pharmaceuticals

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)

January 15, 2026

Study Completion (Estimated)

January 15, 2026

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)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 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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