Clinical trials: Inflammatory Bowel System
Ulcerative Colitis (UC)
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
- Trial name
- LEGACY (NCT01848561)
- Where
- 512 sites in United States, Australia and 19 more
- Volunteers
- 8,250 people
- Sponsor
- AbbVie
Colitis, Ulcerative
Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.
- Trial name
- NCT00747110
- Testing
- budesonide, mesalazine
- Where
- Germany
- Volunteers
- 343 people
- Sponsor
- Dr. Falk Pharma GmbH
IBS - Irritable Bowel Syndrome, Inflammation
Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life.
- Trial name
- NCT04348760
- Testing
- Rotation Diet
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- GEK Srl
Ulcerative Colitis
Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part…
- Trial name
- NCT04458805
- Testing
- NX-13 250 mg
- Where
- Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Landos Biopharma Inc.
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 (UC)
Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis
The purpose of this phase III, multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Hemay005 compared to placebo as induction and maintenance therapy in Chinese participants with…
- Trial name
- NCT07650942
- Testing
- Hemay005 tablet
- Where
- 2 sites in China
- Volunteers
- 360 people
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Crohn's Disease
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD).
- Trial name
- NCT00055367
- Testing
- natalizumab
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Biogen
Crohn's Disease
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease.
- Trial name
- COSPAR1 (NCT00349752)
- Testing
- certolizumab pegol 400 mg
- Where
- 68 sites in United States, Canada and 1 more
- Volunteers
- 174 people
- Sponsor
- UCB Pharma
Ulcerative Colitis
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age).
- Trial name
- NCT05287126
- Testing
- Etrasimod
- Where
- 47 sites in United States, Japan and 3 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
Ulcerative Colitis Chronic Moderate
Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)
The PROCTO trial is a double-blind randomized, placebo-controlled, 24-week, comparative, exploratory phase II proof of concept trial.
- Trial name
- PROCTO (NCT03565939)
- Testing
- Trichuris suis ova
- Where
- Denmark
- Volunteers
- 119 people
- Sponsor
- ParaTech A/S
Crohn's Disease
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a…
- Trial name
- NCT00105300
- Testing
- Adalimumab
- Where
- 56 sites in United States, Belgium and 2 more
- Volunteers
- 300 people
- Sponsor
- Abbott
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
Active Ulcerative Colitis, Remission of Ulcerative Colitis
Canadian Active & Maintenance Modified Pentasa Study
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative…
- Trial name
- CAMMP (NCT00603733)
- Testing
- 5-ASA (5-Aminosalicylate)
- Where
- 27 sites in Canada
- Volunteers
- 288 people
- Sponsor
- Ferring Pharmaceuticals
Crohn's Disease
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission…
- Trial name
- GEMINI II (NCT00783692)
- Testing
- vedolizumab
- Where
- 114 sites in United States, Canada and 1 more
- Volunteers
- 1,116 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Crohn's Disease, Obesity or Overweight
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and…
- Trial name
- COMMIT-CD (NCT06937099)
- Testing
- Mirikizumab, Tirzepatide
- Where
- 183 sites in United States, Austria and 20 more
- Volunteers
- 290 people
- Sponsor
- Eli Lilly and Company
Inflammatory Bowel Disease
Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.
- Trial name
- NCT01981616
- Testing
- Vedolizumab, Hepatitis B vaccine, Oral cholera vaccine
- Where
- United Kingdom
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
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
Rheumatoid Arthritis, Ankylosing Spondylitis
Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice
The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Crohn´s Disease
- Trial name
- Adherence (NCT01768858)
- Testing
- Adalimumab
- Volunteers
- 96 people
- Sponsor
- AbbVie
Ulcerative Colitis
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
- Trial name
- OPAL (NCT02808780)
- Where
- 63 sites in United States, Austria and 7 more
- Volunteers
- 535 people
- Sponsor
- Janssen Biotech, Inc.
Ulcerative Colitis
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate…
- Trial name
- NCT01456052
- Testing
- Telotristat Etiprate
- Where
- 24 sites in United States, Lithuania and 2 more
- Volunteers
- 59 people
- Sponsor
- Lexicon Pharmaceuticals