Clinical trials: Inflammatory Bowel Disease
Moderate to Severe Ulcerative Colitis
Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo
The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life [QoL]), workability, and disease activity.
- Trial name
- AdaProQuo (NCT02092389)
- Volunteers
- 10 people
- Sponsor
- AbbVie
Ulcerative Colitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC.
- Trial name
- NCT03558152
- Testing
- UTTR1147A, Vedolizumab
- Where
- 72 sites in United States, Bulgaria and 14 more
- Volunteers
- 195 people
- Sponsor
- Genentech, Inc.
Colitis, Ulcerative
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
- Trial name
- NCT03535649
- Where
- 15 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- Takeda
Crohn Disease, Inflammatory Bowel Disease (IBD)
Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals
This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and…
- Conditions
- Crohn Disease, Inflammatory Bowel Disease (IBD), Colitis Ulcerative
- Trial name
- NCT07682038
- Testing
- Routine hospital care data (observational)
- Volunteers
- 3,500 people
- Sponsor
- LOGEX
Inflammatory Bowel Disease
Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
- Trial name
- NCT03555617
- Testing
- TD-1473, Itraconazole
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Crohn Disease, Colitis, Ulcerative
A Long-term Extension Study of Ustekinumab in Pediatric Participants
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
- Conditions
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
- Trial name
- UNITED (NCT05092269)
- Testing
- Ustekinumab
- Where
- 48 sites in United States, Argentina and 11 more
- Volunteers
- 159 people
- Sponsor
- Janssen Research & Development, LLC
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Ulcerative Colitis
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of…
- Trial name
- NCT01612039
- Testing
- ASP3291
- Volunteers
- 112 people
- Sponsor
- Telsar Pharma Inc.
Ulcerative Colitis (UC)
Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants
This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of intravenously administrated ALTB-268 in healthy participants.
- Trial name
- NCT07350577
- Testing
- ALTB-268
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- AltruBio Inc.
Mild to Moderate Ulcerative Colitis
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were: To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800…
- Trial name
- NCT01045018
- Testing
- Mesalamine
- Sponsor
- EMET Pharmaceuticals, LLC
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Crohn's Disease
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4…
- Trial name
- ANDANTE (NCT01287897)
- Testing
- PF-04236921 SC injection
- Where
- 193 sites in United States, Australia and 16 more
- Volunteers
- 250 people
- Sponsor
- Pfizer
Spondyloarthritis
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions.
- Trial name
- Annexin 03 (NCT03232580)
- Testing
- rhAnnexin V-128
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Advanced Accelerator Applications
Chronic Disease, HIV/AIDS
Observational Pharmaco-Epidemiology Research & Analysis
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management…
- Conditions
- Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases
- Trial name
- OPERA (NCT03813862)
- Testing
- Non-interventional (observational only)
- Where
- United States
- Volunteers
- 2,000,000 people, healthy volunteers welcome
- Sponsor
- Epividian
Crohn's Disease
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease.
- Trial name
- NCT00032786
- Testing
- natalizumab
- Sponsor
- Biogen
Gastric or Duodenal Ulcers
Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs
The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal…
- Trial name
- NCT02099708
- Testing
- Lansoprazole
- Volunteers
- 3,502 people
- Sponsor
- Takeda
Crohn's Disease
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).
- Trial name
- CARMEN CD 307 (NCT03627091)
- Testing
- Ontamalimab
- Where
- 281 sites in United States, Argentina and 32 more
- Volunteers
- 40 people
- Sponsor
- Shire
Crohn's Disease
EPANOVA in Crohn's Disease, Study 1
The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI < 150) in CD patients in whom…
- Trial name
- EPIC-1 (NCT00613197)
- Testing
- Epanova
- Where
- Belgium
- Volunteers
- 384 people
- Sponsor
- Tillotts Pharma AG
Crohn's Disease
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease.
- Trial name
- NCT01190410
- Testing
- certolizumab pegol
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 16 people
- Sponsor
- UCB Pharma
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
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