Clinical trials: Colitis
Ulcerative Colitis
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
- Trial name
- NCT00808977
- Testing
- Dersalazine sodium, Mesalazine
- Where
- 22 sites in Belgium, Hungary and 2 more
- Volunteers
- 80 people
- Sponsor
- Palau Pharma S.L.U.
Ulcerative Colitis
ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis
Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments…
- Trial name
- NCT00781638
- Testing
- Adacolumn®
- Volunteers
- 24 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Pouchitis
Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry.
- Trial name
- NCT00583531
- Testing
- AST-120
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Ocera Therapeutics
Ulcerative Colitis
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an…
- Trial name
- NCT05976802
- Testing
- High dose budesonide rectal foam, Low dose budesonide rectal foam
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
- Trial name
- NCT04023396
- Testing
- ABX464
- Where
- 120 sites in Austria, Belarus and 14 more
- Volunteers
- 217 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis (UC)
A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis
This Phase IIa, multicenter, single-arm trial evaluates the efficacy, safety, tolerability, and pharmacokinetics of PTT-621 tablets in adults (18-70 years) with moderate-to-severe active ulcerative colitis (UC) who have…
- Trial name
- NCT07747155
- Testing
- PTT-621 Tablets
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Pyrotech Therapeutics, Inc.
Ulcerative Colitis
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
- Trial name
- NCT04205643
- Testing
- CT-P13 SC (Infliximab)
- Where
- Poland
- Volunteers
- 548 people
- Sponsor
- Celltrion
Crohn Disease, Colitis, Ulcerative
A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD)…
- Trial name
- G-FORCE (NCT07606339)
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Janssen-Cilag Pharma GmbH
Crohn's Disease
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
- Trial name
- NCT00078611
- Testing
- natalizumab
- Where
- 75 sites in United States, Canada
- Volunteers
- 462 people
- Sponsor
- Biogen
Ulcerative Colitis
A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment.
- Trial name
- PULSE (NCT03849599)
- Testing
- PRV-300
- Where
- 3 sites in Georgia, Moldova and 1 more
- Volunteers
- 37 people
- Sponsor
- Provention Bio, Inc.
Colitis, Ulcerative
Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea
The purpose of this study is to describe clinical course of newly diagnosed moderate to severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral hospitals in Korea for 5-year follow-up under…
- Trial name
- MOSAIK (NCT02229344)
- Testing
- No Intervention
- Where
- 15 sites in South Korea
- Volunteers
- 368 people
- Sponsor
- Janssen Korea, Ltd., Korea
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Ulcerative Colitis
A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT06281704
- Testing
- AK101 IV, AK101 SC, AK101 IV/AK101 SC
- Where
- 12 sites in China
- Volunteers
- 34 people
- Sponsor
- Akeso
Colitis, Hepatitis
PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.
- Conditions
- Colitis, Hepatitis, Melanoma (Skin Cancer)
- Trial name
- PHOENIX-ECP (NCT07619898)
- Testing
- methoxsalen, Extracorporeal photopheresis (ECP), Vedolizumab
- Volunteers
- 112 people
- Sponsor
- Therakos LLC
Ulcerative Colitis
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.
- Trial name
- NCT00219414
- Testing
- Adacolumn Apheresis System
- Volunteers
- 42 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Ulcerative Colitis
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
- Trial name
- NCT02039505
- Testing
- Vedolizumab
- Where
- 59 sites in Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
Crohn Disease, Ulcerative Colitis
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in patients with ulcerative colitis and Crohn disease.
- Conditions
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- Trial name
- NCT07383597
- Testing
- Efferon LPS
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Efferon JSC
Mild to Moderate Ulcerative Colitis
Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
This is a multi-center study in Ireland and United Kingdom to determine the effects, safety and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis (UC).
- Trial name
- NCT01033305
- Testing
- CyCol™
- Where
- 22 sites in Ireland, United Kingdom
- Volunteers
- 118 people
- Sponsor
- Sigmoid Pharma
Ulcerative Colitis, Crohn's Disease
Predicting Medication Response for Autoimmune Disease
Coral is conducting a large study comparing and predicting the relative effectiveness of different medications for autoimmune patients.
- Conditions
- Ulcerative Colitis, Crohn's Disease, Psoriasis, Rheumatoid Arthritis
- Trial name
- REEF (NCT04995783)
- Testing
- Coral FRS test
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Coral Genomics, Inc.
Ulcerative Colitis
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
- Trial name
- NCT05181137
- Testing
- SHR0302
- Where
- 113 sites in United States, China and 3 more
- Volunteers
- 368 people
- Sponsor
- Reistone Biopharma Company Limited