Clinical trials: Inflammatory Bowel Disease
Crohn's Disease (CD)
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- COMANDOR (NCT07078994)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 204 people
- Sponsor
- Biocad
Crohn Disease
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.
- Trial name
- NCT02974322
- Testing
- GED-0301
- Where
- 311 sites in United States, Australia and 28 more
- Sponsor
- Celgene
Ulcerative Colitis
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ELEVATE UC 12 (NCT03996369)
- Testing
- Etrasimod
- Where
- 407 sites in United States, Argentina and 39 more
- Volunteers
- 354 people
- Sponsor
- Arena Pharmaceuticals
Ulcerative Colitis
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.
- Trial name
- NCT06627556
- Testing
- H021
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jiangsu Carephar Pharmaceutical Co., Ltd.
Crohn Disease (CD)
HB-adMSCs for the Treatment of Crohn's Disease
Methodology: Randomized, double-blind, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease with a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post…
- Trial name
- NCT07077746
- Testing
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells, 0.9% sodium chloride
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Hope Biosciences Research Foundation
Inflammatory Bowel Disease
Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease
The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis or Crohn's Disease.
- Trial name
- NCT03414788
- Testing
- PF 06687234, [124I]IB PF 06687234
- Where
- United States
- Sponsor
- Pfizer
Crohn's Disease
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration…
- Trial name
- NCT02611817
- Testing
- Vedolizumab SC 108 mg, Vedolizumab IV 300 mg
- Where
- 194 sites in United States, Australia and 28 more
- Volunteers
- 644 people
- Sponsor
- Takeda
Colitis, Ulcerative, Crohn Disease
A Study of Vedolizumab in Adults in Real-World Practice
Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease.
- Trial name
- NCT04872491
- Where
- 40 sites in China
- Volunteers
- 500 people
- Sponsor
- Takeda
Gastrointestinal Disease, Inflammatory Bowel Disease (IBD)
Elemental 028 Extra Case Studies
Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to…
- Conditions
- Gastrointestinal Disease, Inflammatory Bowel Disease (IBD), Short Bowel, Malabsorption
- Trial name
- E028E (NCT06877923)
- Testing
- Elemental 028 Extra
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Crohn Disease
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to…
- Trial name
- ATTIC (NCT05594862)
- Testing
- Lipogems
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Lipogems International spa
Ulcerative Colitis
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg…
- Trial name
- NCT00254618
- Testing
- mesalamine
- Where
- 22 sites in United States
- Volunteers
- 34 people
- Sponsor
- Warner Chilcott
Ulcerative Colitis
An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- SCOUT (NCT05084261)
- Testing
- BT051 200 mg, BT051 800 mg, BT051 3200 mg
- Where
- 6 sites in United States, Georgia and 2 more
- Volunteers
- 24 people
- Sponsor
- Adiso Therapeutics
Ulcerative Colitis
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
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…
- Trial name
- NCT04556383
- Testing
- GB004
- Where
- 77 sites in United States, Georgia and 7 more
- Volunteers
- 236 people
- Sponsor
- GB004, Inc.
Ulcerative Colitis (UC), Crohn Disease (CD)
VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation
The aim of this observational study is to evaluate Effectiveness and safety of VedAryo® (Vedolizumab) in male or female participants with clinical diagnosis of Inflammatory Bowel Disease. The main questions are aim to answer: 1.
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD), Inflammatory Bowel Disease (IBD)
- Trial name
- NCT07273760
- Testing
- Vedolizumab
- Where
- 12 sites in Iran
- Volunteers
- 150 people
- Sponsor
- AryoGen Pharmed Co.
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2…
- Trial name
- NCT00417690
- Testing
- 4-Aminosalicylic acid
- Where
- 5 sites in United States, Israel
- Volunteers
- 54 people
- Sponsor
- Jacobus Pharmaceutical
Stomach Ulcer, Duodenal Ulcer
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid…
- Trial name
- NCT00787254
- Testing
- Lansoprazole, Gefarnate
- Where
- 68 sites in Japan
- Volunteers
- 366 people
- Sponsor
- Takeda
Ulcerative Colitis
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
- Trial name
- NCT00787202
- Testing
- CP- 690 550
- Where
- 59 sites in Belgium, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Pfizer
Ulcerative Colitis
ABTECT - Maintenance
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active…
- Trial name
- NCT05535946
- Testing
- ABX464
- Where
- 413 sites in United States, Argentina and 32 more
- Volunteers
- 1,116 people
- Sponsor
- Abivax S.A.
Inflammatory Bowel Diseases, Irritable Bowel Syndrome
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation.
- Trial name
- NCT03082287
- Testing
- Fecal Calprotectin Level
- Where
- United States
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
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
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