Clinical trials: Refractory Ulcerative Colitis
Ulcerative Colitis, Active Moderate
Adacolumn in Refractory UC Patients Trial
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients.
- Trial name
- ART (NCT01481142)
- Testing
- (GMA) Adsorptive Apheresis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Clostridium Difficile Infection, Ulcerative Colitis
Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis
Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational…
- Conditions
- Clostridium Difficile Infection, Ulcerative Colitis, Indeterminate Colitis
- Trial name
- FMT (NCT03268213)
- Testing
- Fecal Microbial Transplantation
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stony Brook University
Colitis, Ulcerative
Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa
Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients…
- Trial name
- NCT03460847
- Testing
- Steroids
- Where
- Austria
- Volunteers
- 114 people
- Sponsor
- Medical University of Graz
Ulcerative Colitis, Crohn Disease
Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease
The gut microbiota is determined to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism.
- Conditions
- Ulcerative Colitis, Crohn Disease, Constipation (Excl Faecal Impaction)
- Trial name
- NCT02575040
- Testing
- Fecal microbiota transplantation
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Cmv Colitis
Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis
Aim of the work To identify the prevalence of CMV infection in patients with steroid-refractory ulcerative colitis. To assess the clinical and endoscopic conditions in these patients.
- Trial name
- NCT03467841
- Testing
- CMV IgM, IgG in blood real time PCR for serum CMV DNA .
- Volunteers
- 50 people
- Sponsor
- Dr mohammedRmadan hamad
Ulcerative Colitis
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in…
- Trial name
- NCT00347048
- Testing
- tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Ulcerative Colitis, Inflammatory Bowel Diseases
Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)
The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic/advanced therapy relapsed/refractory moderately to severely active UC.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Autoimmune Diseases
- Trial name
- Aegean (NCT07513181)
- Testing
- ATH-063
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Athos Therapeutics Inc
Intravenous Steroid-Refractory Ulcerative Colitis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.
- Trial name
- NCT00502294
- Testing
- Visilizumab (HuM291; Nuvion®)
- Volunteers
- 150 people
- Sponsor
- Facet Biotech
Ulcerative Colitis
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.
- Trial name
- NCT00355901
- Testing
- Visilizumab (Nuvion®; HuM291)
- Where
- 40 sites in United States, Australia and 12 more
- Volunteers
- 300 people
- Sponsor
- PDL BioPharma, Inc.
Ulcerative Colitis
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC.
- Trial name
- NCT06109441
- Testing
- ALTB-268
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- AltruBio Inc.
Inflammatory Bowel Diseases (IBD)
BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with relapsed and/or refractory…
- Trial name
- NCT07544160
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T
- Where
- China
- Volunteers
- 18 people
- Sponsor
- iCell Gene Therapeutics
Ulcerative Colitis, Pediatric, Inflammatory Bowel Diseases
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD).
- Conditions
- Ulcerative Colitis, Pediatric, Inflammatory Bowel Diseases, Crohn Disease
- Trial name
- COMPARE (NCT07198113)
- Where
- 4 sites in United States
- Volunteers
- 1,100 people
- Sponsor
- University of North Carolina, Chapel Hill
UC
Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study
A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study on the Use of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis: A Preliminary Exploration of 12-Week…
- Trial name
- NCT07435779
- Testing
- BCMA CAR-T or CD19 CAR-T or CD19×BCMA
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
Ulcerative Colitis, Steroid Refractory
Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis
PHASE: IV TYPE OF STUDY: With direct benefit. DESCRIPTIVE: Multicenter, randomized, open label study. INCLUSION CRITERIA: Steroid-refractory ulcerative colitis.
- Trial name
- CYSIF (NCT00542152)
- Testing
- CYCLOSPORINE VS INFLIXIMAB
- Where
- 41 sites in Belgium, Finland and 3 more
- Volunteers
- 115 people
- Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Pouchitis, Crohn's Disease
Stem Cells for the Treatment of Pouchitis
The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.
- Conditions
- Pouchitis, Crohn's Disease, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases
- Trial name
- NCT05578508
- Testing
- Mesenchymal Stem Cells (MSCs)
- Where
- United States
- Sponsor
- The Cleveland Clinic
Ulcerative Colitis
Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.
- Trial name
- NCT00643071
- Testing
- Tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Astellas Pharma Inc
Ulcerative Colitis
Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis
This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids
- Trial name
- TOCASU (NCT05112263)
- Testing
- Tofacitinib, Cyclosporine
- Volunteers
- 96 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Ulcerative Colitis
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled…
- Trial name
- PREDICT UC (NCT02770040)
- Testing
- Infliximab
- Where
- Australia
- Volunteers
- 138 people
- Sponsor
- Austin Health
Ulcerative Colitis
Antimicrobial Therapy for Ulcerative Colitis (UC)
The Aim of this randoized controlled pilot study is to find a better treatment strategy for active UC based on the recent knowledge regarding the microbiota in UC and the beneficial or detrimental effects of antibiotics in…
- Trial name
- UC (NCT03986996)
- Testing
- amoxicillin, metronidazole and doxycycline, amoxicillin and doxycyclin
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Wolfson Medical Center
Ulcerative Colitis
Basiliximab in Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
- Trial name
- NCT00430898
- Testing
- Basiliximab
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 181 people
- Sponsor
- Cerimon Pharmaceuticals