A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active...
Crohn's DiseaseThe purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients...
Crohn DiseaseThe purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.
Fecal Microbial Transplantation in Patients With Crohn's Disease
Crohn DiseaseFecal Microbiota Transplantation will be offered to eligible Crohn's disease patient as Investigational New Drug treatment
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients...
Crohn's DiseaseUlcerative Colitis (Part 2 Only)Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
Triple Combination Therapy in High Risk Crohn's Disease (CD)
Crohn DiseaseThe purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.
Study of Bacteroides Thetaiotaomicron in Young People Aged 16 to 18 Years With Stable Crohn's Disease...
Crohn's DiseaseThe purpose of this study is to assess the safety and tolerability of Bacteroides thetaiotaomicron (Thetanix®)) capsules in young people aged 16 to 18 years with stable Crohn's disease.
Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants...
Crohn's DiseaseCrohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics...
Ulcerative Colitis (UC)Crohn's DiseaseUlcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD. Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide. In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201
Ulcerative ColitisCrohn's DiseaseThis will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD & MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.
B0151005 Open-Label Extension Study
Crohn's DiseaseThis is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.