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Researchers are studying the long-term safety of vedolizumab given as a subcutaneous injection to children and teenagers aged 2 to 17 years with moderate to severe active ulcerative colitis UC or Crohns disease CD. The study aims to understand medical problems that may arise from extended use of vedolizumab SC, as well as its impact on hospital visits due to bowel inflammation and on the quality of life for these young participants. This Phase 3b extension study follows participants from an earlier study VedolizumabSC-3003 who have responded well or not to treatment. Participants who responded well to vedolizumab SC in the parent study will continue treatment in this extension study, receiving the same dose and frequency. They will be randomly assigned to receive vedolizumab 108 mg either via a prefilled syringe with an autoinjector pen or with a needle safety device. Dosage is every two weeks for participants weighing at least 30 kg and every four weeks for those weighing between 10 and under 30 kg. Those who did not respond well or recently used corticosteroids will not receive vedolizumab in this study but will be observed in an observational cohort. Throughout the study, participants will visit their study clinic multiple times over up to two years. Researchers will monitor adverse events and serious adverse events up to 18 weeks after the last dose, as well as special safety events in the observational group. They will also assess time to major inflammatory bowel disease-related events and changes in quality of life using the IMPACT-III questionnaire at regular intervals. Participants will have a safety follow-up visit after treatment ends, and those in the observational group will be followed for about two years after their last dose in the parent study.

Researchers are evaluating the safety and effectiveness of ozanimod RPC1063 in helping children and teenagers with moderate to severe active ulcerative colitis UC who have not responded well to standard treatments. The study focuses on whether ozanimod can help achieve and maintain clinical remission in this young population. This research is conducted as a phase 2 and phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive ozanimod orally in either a high dose or low dose as part of the study. The treatment is given on specified days, and participants are randomly assigned to one of these dosing groups. The study uses a quadruple masking design, meaning that participants, caregivers, investigators, and assessors do not know which dose is given. The main study period will last up to 52 weeks, with ongoing assessments for up to 6 years to monitor longer-term outcomes and safety. During the study, participants will be monitored regularly for clinical remission, symptomatic remission, clinical response, and endoscopic improvement at various time points including weeks 10 and 52. Researchers will also track corticosteroid-free remission and measure blood levels of the drug and its metabolites. Safety is closely observed by recording adverse events, serious adverse events, and events leading to treatment discontinuation. The study involves clinical visits, endoscopic exams, and laboratory tests throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This phase 3 study is designed to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.

Researchers are evaluating the clinical and endoscopic effects of guselkumab in children aged 2 to 17 years with moderately to severely active Crohns Disease who show clinical response at Week 12. This Phase 3 study focuses on assessing the treatments impact at the end of a one-year maintenance period in pediatric participants with this condition. The trial is sponsored by Janssen Research & Development, LLC. Participants first receive guselkumab either intravenously or subcutaneously based on their body weight during a 12-week open-label induction phase. Those who respond at Week 12 are then randomly assigned to one of two subcutaneous guselkumab dosing regimens for a double-blind maintenance phase lasting up to Week 48. Non-responders at Week 12 enter an open-label maintenance phase with guselkumab subcutaneous dosing up to Week 48. Throughout the study, participants undergo clinical and endoscopic evaluations to measure remission and response rates, including endoscopic scores and clinical remission at Week 52. Additional assessments include growth measurements such as weight and height changes, and plasma concentrations of guselkumab. Safety is monitored with adverse event tracking up to Week 64, with the total duration of participation spanning just over one year.

Researchers are evaluating mirikizumab for children and teenagers aged 2 to 17 years with moderately to severely active Crohns disease, including fistulizing Crohns disease with active inflammation in the colon or ileum. The study aims to assess the treatments effectiveness, safety, tolerability, and how well it is absorbed in the body. Participants must have a history of inadequate response or intolerance to other Crohns disease medications and will be randomly assigned to receive mirikizumab or another intervention. The treatment involves receiving mirikizumab either intravenously IV or subcutaneously SC, with dosing based on the participants weight in three different weight groups over 40 kg, 20 to 40 kg, and 9 to 20 kg. The study includes a 12-week induction period, followed by a maintenance phase lasting until Week 52. After treatment, there is a safety follow-up period lasting up to 16 weeks. The entire study spans about 74 weeks and may include up to 19 visits. Participants will undergo assessments including clinical response evaluations by the Pediatric Crohns Disease Activity Index PCDAI, endoscopic assessments using the Simple Endoscopic Score for Crohns Disease SES-CD, and laboratory tests such as C-reactive protein and fecal calprotectin levels. Pharmacokinetic studies will measure how the drug is cleared and distributed in the body. Safety monitoring continues during the follow-up period to track any adverse events or treatment tolerability throughout the study duration.

Researchers are studying vedolizumab, a medicine designed to reduce inflammation and pain in the digestive system, for children and teenagers with moderate to severe Crohns disease who have not responded well or were intolerant to standard treatments. The main goal is to see if participants can achieve remission, meaning their symptoms improve or disappear and endoscopy shows no inflammation. This phase 3, randomized, double-blind study involves about 120 pediatric participants worldwide. Participants will receive three intravenous infusions of vedolizumab over six weeks during the Induction Period, with doses based on their weight. Those who show a clinical response at Week 14 will be randomly assigned to receive either a high or low dose of vedolizumab every eight weeks up to Week 46 during the Maintenance Period. Dose adjustments may be made if disease worsens, and corticosteroid rescue therapy is allowed once during maintenance. After Week 54, eligible participants may continue treatment in an extension study or enter long-term follow-up. Throughout the study, participants will undergo assessments including clinical evaluations, endoscopies, and laboratory tests to measure disease activity and remission using tools like the Pediatric Crohns Disease Activity Index and Simple Endoscopic Score for Crohns Disease. Safety will be monitored through reports of adverse events and antibody levels against vedolizumab. The total participation can include additional safety visits and up to two years of long-term follow-up after the last dose.

This research is focused on children and teenagers aged 2 to 17 years who have moderately to severely active ulcerative colitis UC or Crohns disease CD. It aims to evaluate how their bodies process vedolizumab given under the skin, and to study the drugs safety and immune response effects. The study involves participants who have already shown improvement after receiving vedolizumab through intravenous infusion. Participants will first receive three doses of vedolizumab through intravenous infusion during an Induction Period at Day 1, Week 2, and Week 6, with the dosage based on their weight. Those who respond positively by Week 14 will enter a Maintenance Period where they receive vedolizumab under the skin every 2 or 4 weeks, depending on their weight, for up to 20 weeks. After the treatment period ends at Week 34, some participants may continue treatment in an extension study, while others will complete a follow-up safety visit 18 weeks after their last dose. During the study, participants will visit the clinic several times for treatment and assessments. Researchers will measure how vedolizumab levels stay in the blood over time and monitor immune responses. Safety visits will follow to observe any side effects or reactions after treatment ends. The total treatment duration is up to 34 weeks with an additional 18 weeks of follow-up for some participants.

This research aims to collect long-term safety data on vedolizumab in children with ulcerative colitis UC or Crohns disease CD who have previously participated in related parent studies. It involves up to 240 participants worldwide, including those from treatment or observational cohorts, to better understand the effects of vedolizumab in pediatric patients with these conditions. In the treatment cohort, participants receive intravenous vedolizumab at doses based on their weight, continuing the same blinded dose they received in the parent study at Week 46. Doses are given every 8 weeks, with options ranging from 100 mg to 300 mg depending on participant weight. The study duration in this cohort is up to approximately 5 years or until treatment becomes commercially available or the study closes. The observational cohort includes participants who received at least one dose in the parent study but are not continuing treatment they are followed for safety events for up to about 2 years without receiving vedolizumab. Participants attend assessment visits at several time points after their last dose in the parent study to monitor safety, growth, and development. Researchers track adverse events, inflammatory bowel disease-related events, and changes in quality of life scores using IMPACT-III questionnaires every 24 weeks. The study also includes a final safety visit 18 weeks after the last dose in the treatment cohort. Overall participation lasts up to 5 years for treated children and up to 2 years for those in the observational group.