Treatment of Moderate to Severe Refractory Crohn's Disease
This research study is testing an investigational research product called TRX103 as a
possible treatment for individuals suffering from Crohn's Disease (CD). The primary
purpose of this study is to learn how safe and effective different doses of TRX103 are
when admin...
Age: 18 - 65 years
Gender: All
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness,
swelling), in the digestive tract, most often affecting the bowels. It can cause many
different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This
stud...
Age: 2 - 17 years
Gender: All
Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation
The PLANET Study aims to determine the impact of microplastics on intestinal inflammation
and gut microbiome in order to understand the role of this pollutant on the risk of
developing inflammatory bowel disease (IBD) as well as other diseases. With this
information,...
Age: 18 years - 66+
Gender: All
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with
or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess
the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with
...
Age: 2 - 17 years
Gender: All
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical and endoscopic efficacy of
guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance
therapy (Week 52) among participants who were in clinical response to guselkumab at Week
12.
Age: 2 - 17 years
Gender: All
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug
effects of ozanimod in pediatric participants with moderately to severely active Crohn's
Disease.
Age: 2 - 17 years
Gender: All
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
Age: 2 - 17 years
Gender: All
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in
pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study
will last about 172 weeks and may include up to 44 visits. Additional treatment may be
availa...
Age: 2 - 19 years
Gender: All
Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial
The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing
(iDose-driven dosing) is more effective and safer than standard infliximab dosing for
inducing and maintaining disease remission in inflammatory bowel disease.
Age: 16 years - 66+
Gender: All
Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
The MELODY Trial: Modulating Early Life Microbiome through Dietary Intervention in Crohn's
Disease, will test whether a non-invasive dietary intervention during pregnancy can improve
the gut microbiota composition in both pregnant Crohn's disease patients and their ...
Age: 18 years - 66+
Gender: Female
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
The purpose of this study is to compare the efficacy of treatment with ustekinumab or
adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease
(CD) who have previously failed or were intolerant to conventional therapy (corticosteroi...
Age: 18 years - 66+
Gender: All
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects
from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old
in other countries and determine if it is similar to that observed in adults wit...
Age: 2 - 17 years
Gender: All