Clinical trials: Refractory Ulcerative Colitis
Ulcerative Colitis
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
- Trial name
- TURANDOT II (NCT01771809)
- Testing
- 75mg SHP647 (PF-00547659), 225mg SHP647 (PF-00547659)
- Where
- 99 sites in United States, Australia and 19 more
- Volunteers
- 330 people
- Sponsor
- Shire
Severe Ulcerative Colitis
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy.
- Trial name
- NCT00267306
- Testing
- Visilizumab
- Where
- 11 sites in United States
- Volunteers
- 144 people
- Sponsor
- Facet Biotech
Ulcerative Colitis
A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
- Trial name
- NCT00279422
- Testing
- visilizumab
- Where
- 70 sites in United States, Australia and 12 more
- Volunteers
- 127 people
- Sponsor
- Facet Biotech
Ulcerative Colitis
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine
- Trial name
- PROTECT-3 (NCT02849951)
- Testing
- LT-02
- Where
- 45 sites in United States
- Volunteers
- 25 people
- Sponsor
- Prometheus Laboratories
Ulcerative Colitis
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
- Trial name
- NCT00279435
- Testing
- visilizumab
- Where
- 39 sites in United States, Australia and 13 more
- Volunteers
- 25 people
- Sponsor
- Facet Biotech
Ulcerative Colitis
Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
This study is designed as a proof of concept of KRP203 for induction of remission in ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory…
- Trial name
- NCT01375179
- Testing
- KRP203
- Where
- 14 sites in Belgium, Germany and 4 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis
CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical response to IFX will be evaluated through the PUCAI score.
- Trial name
- NCT05430412
- Testing
- Adacolumn
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 15 people
- Sponsor
- Adacyte Therapeutics SL
Ulcerative Colitis
Research Study in Patients With Severe Ulcerative Colitis
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy.
- Trial name
- NCT00032305
- Testing
- Visilizumab
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Facet Biotech
Ulcerative Colitis, Inflammatory Bowel Diseases
Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis
Protocol Summary Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory ulcerative…
- Trial name
- NCT05176366
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Direct Biologics, LLC
Ulcerative Colitis
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active…
- Trial name
- NCT03093259
- Testing
- ABX464
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 32 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis
The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.
- Trial name
- PROTECT-1 (NCT02142725)
- Testing
- LT-02
- Where
- Germany
- Volunteers
- 468 people
- Sponsor
- Dr. Falk Pharma GmbH
Colitis, Ulcerative
The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients
The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.
- Trial name
- COLLECT (NCT01493960)
- Testing
- Cobitolimod
- Where
- 37 sites in Czechia, France and 5 more
- Volunteers
- 131 people
- Sponsor
- InDex Pharmaceuticals
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
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
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.