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Colitis, Ulcerative clinical trials

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NCT ID: NCT05479058 Terminated - Ulcerative Colitis Clinical Trials

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

CAPYBARA
Start date: July 26, 2022
Phase: Phase 3
Study type: Interventional

Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

NCT ID: NCT04985968 Terminated - Ulcerative Colitis Clinical Trials

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

CONCLUDE
Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

NCT ID: NCT04968951 Terminated - Ulcerative Colitis Clinical Trials

Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

REFOCUS
Start date: November 10, 2021
Phase: Early Phase 1
Study type: Interventional

The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors. Donors will be specifically screened for Fusobacterium and Sutterella species as well as for global diversity. It is unknown if treatment with antibiotics before FMT improves the engraftment and/or efficacy of FMT in UC, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before FMT therapy. The research team enroll patients from The Susan and Leonard Feinstein IBD Center and our established early diagnosis clinic at Mount Sinai Hospital (MSH).

NCT ID: NCT04677179 Terminated - Colitis, Ulcerative Clinical Trials

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

INSTRUCT-UC
Start date: March 22, 2021
Phase: Phase 2
Study type: Interventional

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

NCT ID: NCT04613518 Terminated - Colitis, Ulcerative Clinical Trials

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

Start date: March 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.

NCT ID: NCT04576000 Terminated - Ulcerative Colitis Clinical Trials

Identification of Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis

PROPHETIC
Start date: August 25, 2020
Phase:
Study type: Observational

This study aims to provide new mechanistic insights into the molecular determinants of response or nonresponse to Janus Kinase inhibitor therapy and the biological heterogeneity that exists in Ulcerative Colitis. This study will include patients who are initiating Janus Kinase inhibitor therapy according to standard of care. This study consists of: - Part 1: 8 or 10 week induction therapy followed by an 8-week maintenance therapy - Part 2: Patients who continue Janus Kinas inhibitor therapy after part 1 will be followed further for a total of 2 years, or until discontinuation of Janus Kinase inhibitor therapy (whichever is first)

NCT ID: NCT04556383 Terminated - Ulcerative Colitis Clinical Trials

A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

Start date: October 19, 2020
Phase: Phase 2
Study type: Interventional

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

NCT ID: NCT04478825 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis

Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.

NCT ID: NCT04457960 Terminated - Healthy Clinical Trials

A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis

Start date: July 1, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).

NCT ID: NCT04434872 Terminated - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT). FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability. Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm. At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level. Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.