Clinical trials: Inflammatory Bowel Diseases
Ulcerative Colitis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)
- Trial name
- NCT01164904
- Testing
- Amg 181
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Amgen
Crohn's Disease
Mucosal Healing Study in Crohn's Disease (CD)
The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
- Trial name
- MUSIC (NCT00297648)
- Testing
- Certolizumab pegol
- Where
- 19 sites in Belgium, France and 1 more
- Volunteers
- 89 people
- Sponsor
- UCB Pharma
Crohn's Diseases, Crohn's Disease
A Phase 1 Study of ATORM-C in Patients With Crohn's Disease
This Phase 1 study evaluates the safety and tolerability of ATORM-C in patients with Crohn's disease. ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids.
- Trial name
- NCT07822087
- Testing
- Autologous Adult Stem Cell-Derived Intestinal Organoid
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- ORGANOIDSCIENCES LTD.
Chronic Inflammatory Small Bowel Disease
GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors
Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to…
- Trial name
- CLARINET (NCT02797535)
- Testing
- Endoscopy procedures
- Where
- 2 sites in Israel
- Volunteers
- 66 people
- Sponsor
- Medtronic - MITG
Crohn Disease, Ulcerative Colitis
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic…
- Conditions
- Crohn Disease, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis
- Trial name
- OPALE (NCT05051943)
- Where
- France
- Volunteers
- 754 people
- Sponsor
- Fresenius Kabi
A History of Gastric or Duodenal Ulcers
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal…
- Trial name
- NCT03214198
- Testing
- Vonoprazan
- Where
- Japan
- Volunteers
- 1,304 people
- Sponsor
- Takeda
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.
Colitis, Ulcerative, Crohn's Disease
OTIS Vedolizumab Pregnancy Exposure Registry
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to…
- Trial name
- NCT02678052
- Testing
- Vedolizumab, Other Biological Agent
- Where
- United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Takeda
Ulcerative Colitis
Xeljanz Special Investigation for Long-term Use in UC Patients
Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice
- Trial name
- NCT03643211
- Where
- Japan
- Volunteers
- 2,016 people
- Sponsor
- Pfizer
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
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.
- Trial name
- MDX1100-06 (NCT00656890)
- Testing
- sterile saline for injection, MDX-1100
- Where
- 44 sites in United States, Canada and 6 more
- Volunteers
- 110 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis, IBD
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by…
- Trial name
- Expedition (NCT03616821)
- Testing
- Brazikumab
- Where
- 125 sites in United States, Canada and 17 more
- Volunteers
- 242 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4.
- Trial name
- NCT01020708
- Testing
- mesalamine, ALTH12-1:4, ALTH12-2:4
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Altheus Therapeutics, Inc.
Inflammatory Bowel Disease, Anaemia
Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks studies there is a need to follow-up on long term safety and efficacy of any maintenance iron therapy.
- Trial name
- NCT01410435
- Testing
- Monofer
- Where
- 2 sites in Austria, Hungary
- Volunteers
- 39 people
- Sponsor
- Pharmacosmos A/S
Ulcerative Colitis
Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
- Trial name
- NCT04583358
- Testing
- AMT-101 (oral)
- Where
- 59 sites in United States, Belarus and 12 more
- Volunteers
- 105 people
- Sponsor
- Applied Molecular Transport
Ulcerative Colitis
Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative…
- Trial name
- NCT01532648
- Testing
- Budesonide MMX®, 5-ASA
- Where
- 114 sites in United States, Bulgaria and 9 more
- Volunteers
- 510 people
- Sponsor
- Bausch Health Americas, Inc.
Crohn's Disease
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.
- Trial name
- NCT01083680
- Volunteers
- 4,107 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Ulcerative Colitis, Inflammatory Bowel Diseases
BOOM-IBD2 Pivotal Clinical Trial
Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis.
- Trial name
- NCT06571669
- Testing
- Neuromodulation
- Where
- 19 sites in United States
- Volunteers
- 137 people
- Sponsor
- Boomerang Medical
Ulcerative Colitis
FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis.
- Trial name
- NCT00064454
- Testing
- OPC-6535 Tablets (drug)
- Where
- 28 sites in United States
- Volunteers
- 375 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
TD-1473 for Active Ulcerative Colitis (UC)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days.
- Trial name
- NCT02818686
- Testing
- TD-1473
- Where
- 8 sites in United States, Georgia and 2 more
- Volunteers
- 40 people
- Sponsor
- Theravance Biopharma
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