Clinical trials: Inflammatory Bowel Disease (IBD)
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.
Crohn Disease, Recurrence
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first…
- Conditions
- Crohn Disease, Recurrence, Crohn's Ileocolitis
- Trial name
- NCT04539665
- Testing
- Extended mesenteric resection.
- Where
- 2 sites in Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Montreal General Hospital
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
Inflammatory Bowel Diseases, Dexamethasone
Perioperative Dexamethasone on Postoperative Outcome in IBD
The objective of this RCT is to determine the efficacy of a single preoperative dose of Dexamethasone for accelerating the recovery and reducing the incidence of postoperative complications in adult patients undergoing intestinal…
- Conditions
- Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus, Postoperative Complications
- Trial name
- NCT03456752
- Testing
- Dexamethasone, Normal saline
- Where
- China
- Volunteers
- 302 people
- Sponsor
- Jinling Hospital, China
Crohn Disease
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Autologous ADSVF constitutes an innovative therapeutic strategy that concentrates various types of regenerative stem cells and paracrine factors able to promote angiogenesis and tissue repair.
- Trial name
- ADICROHN2 (NCT04010526)
- Testing
- local co-administration of autologous ADIpose
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Crohn Disease
Loss of RESponse to Ustekinumab Treated by Dose Escalation
The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W)…
- Trial name
- REScUE (NCT04245215)
- Testing
- Ustekinumab
- Where
- Belgium
- Volunteers
- 108 people
- Sponsor
- Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Bowel Disease, Crohn Disease
Development of New Diagnostic Tools in Capsule Endoscopy
Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the…
- Conditions
- Bowel Disease, Crohn Disease, Celiac Disease, Chronic Diarrhea
- Trial name
- NOCE (NCT06152289)
- Where
- France
- Volunteers
- 10,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Crohn Disease, Ulcerative Colitis
Characterization of CD Responders to Vedolizumab
The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.
- Trial name
- NCT04909359
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Miami
Crohn's Disease
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease.
- Trial name
- NCT02233062
- Testing
- Exclusive Enteral Nutrition Therapy
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Jinling Hospital, China
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
The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease
The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in…
- Trial name
- DETECT (NCT02010762)
- Testing
- Vitamin D
- Where
- Netherlands
- Volunteers
- 142 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Inflammatory Bowel Diseases
Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their…
- Trial name
- NCT03591770
- Testing
- SHINGRIX
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Medical Center
Crohn Disease, Stenosis
Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome.
- Trial name
- Long-ProtDilat (NCT06036680)
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Hospital Mutua de Terrassa
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
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