A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
NCT06260267 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2024-10-18
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).
Conditions
Interventions
- DRUG
-
Microbiota suspension
Microbiota suspension
- DRUG
-
Microbiota capsule
Microbiota capsule
- DRUG
-
Placebo suspension
Placebo suspension
- DRUG
-
Placebo capsule
Placebo capsule
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Global Clinical Compliance · Ferring Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-12
- Primary Completion
- 2026-01-15
- Completion
- 2026-01-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Faecal Microbiota Transplantation in Ulcerative Colitis
NCT01896635 ·Status: COMPLETED ·Phase: PHASE2
-
Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
NCT03483246 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
NCT07047339 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
NCT02390726 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
FMT for Remission of Active Ulcerative Colitis in Adults
NCT04202211 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
NCT02958865 ·Status: COMPLETED ·Phase: PHASE2
-
Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
NCT02227342 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Manipulating the Microbiome in IBD by Antibiotics and FMT
NCT02033408 ·Status: COMPLETED ·Phase: NA
-
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
NCT00064441 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
NCT01465763 ·Status: COMPLETED ·Phase: PHASE3
-
Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
NCT04100291 ·Status: TERMINATED ·Phase: NA
-
Fecal Microbiota Transplantation in Ulcerative Colitis
NCT03273465 ·Status: UNKNOWN ·Phase: PHASE2
-
Confirmatory Clinical Study in Active Ulcerative Colitis
NCT07296315 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
NCT00628433 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
NCT04096573 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies
NCT06906445 ·Status: RECRUITING ·Phase: NA
-
Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis
NCT05019742 ·Status: TERMINATED ·Phase: PHASE2
-
Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
NCT03006809 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
NCT04469062 ·Status: WITHDRAWN ·Phase: PHASE3
-
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
NCT05579483 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
NCT02914522 ·Status: COMPLETED ·Phase: PHASE3
-
Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients
NCT03582969 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06290934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
NCT03341962 ·Status: TERMINATED ·Phase: PHASE2
-
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
NCT03518086 ·Status: COMPLETED ·Phase: PHASE3