Wyoming

Researchers are evaluating the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis (UC) in a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study. The study is sponsored by Sanofi and aims to assess how well duvakitug maintains clinical remission and improves symptoms in participants who have responded to prior treatment. This investigation includes a long-term follow-up to understand the treatment's effects over several years. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension (OLE) phase for those who continue treatment. Participants not entering the extension phase will have a 45-day follow-up after the maintenance period. The total treatment duration may be up to 280 weeks, with up to 32 on-site visits during the entire study. During the study, participants will undergo regular assessments including clinical remission measured by the modified Mayo Score, endoscopic and histologic evaluations, symptom tracking like bowel urgency and abdominal pain, and quality of life questionnaires. Safety will be monitored through adverse event reporting and serum drug concentration measurements. The primary outcome is the proportion of participants achieving clinical remission at week 40, and the study will also track long-term safety and efficacy outcomes through the extension phase.

Researchers are evaluating new treatments for adults with moderately to severely active ulcerative colitis or Crohn's disease through a master protocol called IIBD. This protocol supports multiple individual sub-studies with shared design features, aiming to assess the effectiveness and safety of these treatments over at least 62 weeks. Participants are assigned to the appropriate study before being randomly placed into treatment groups. The study includes two main treatment periods. In one group, participants receive mirikizumab intravenously during the first period, and responders then receive mirikizumab subcutaneously in the second period. Another group receives a combination of oral LY4395089 and intravenous mirikizumab initially, with responders later stopping LY4395089 and continuing with mirikizumab subcutaneously. These treatments are being compared to understand their effects better. Participants will undergo assessments including clinical evaluations, endoscopic examinations, and laboratory tests to confirm disease activity and monitor response. The primary measurement is the number of participants allocated to each treatment appendix during the first 42 days. The study also tracks safety and treatment response over the course of at least 62 weeks, with ongoing evaluations to gather comprehensive data on these interventions.

Researchers are evaluating the safety and effectiveness of efruxifermin (EFX) in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study will involve about 1,650 participants divided into two groups based on fibrosis stage and will use a randomized, double-blind, placebo-controlled design. Participants will be assigned to receive either 28 mg or 50 mg of efruxifermin or a placebo, all given by weekly subcutaneous injection. The study includes a screening period of up to 12 weeks, a 52-week primary treatment phase, and long-term follow-up that may last up to approximately 240 weeks. Liver biopsies and other assessments will be done at specific times, including weeks 52, 96, and 240, to evaluate liver changes and treatment effects. Throughout the study, participants will undergo various assessments such as liver biopsies, blood tests, FibroScan scans, and questionnaires to monitor liver health, fibrosis progression, and overall safety. Researchers will track outcomes like resolution of NASH/MASH, fibrosis improvement, liver-related events, and survival over the long term. After the last dose, participants will have a follow-up visit about 30 days later to check their condition.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and liver fibrosis at stages F2 or F3. This Phase 3 study aims to better understand how pegozafermin may help treat liver fibrosis in this population. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections according to one of two dosing regimens. The treatments are administered in a randomized, quadruple-masked design to ensure unbiased results. The study evaluates effects after 52 weeks of treatment and monitors participants for up to 5 years to assess disease progression. During the study, participants will undergo liver biopsies to confirm fibrosis stage and will have blood tests to measure liver enzymes and fibrosis markers. Researchers will track improvements in fibrosis, resolution of steatohepatitis, changes in liver enzyme levels, and liver fibrosis scores. Participants' health and safety will be monitored throughout the study period, which includes follow-up assessments extending up to 5 years.

Researchers are evaluating the safety, tolerance, and side effects of brenipatide (LY3537031) in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). This Phase 2, randomized, double-blind, placebo-controlled study aims to compare brenipatide given under the skin with a placebo to assess its safety and effectiveness in treating IBS-D symptoms. The study is sponsored by Eli Lilly and Company and will last approximately 35 weeks. Participants will receive either brenipatide or a placebo via subcutaneous (under the skin) injections. The study includes two groups: one receiving the experimental drug LY3537031 and the other receiving a placebo, both administered in the same way. The treatment period and follow-up will be conducted over several weeks to evaluate the drug's impact on IBS-D symptoms. During the study, participants will record their symptoms daily using an electronic diary, focusing on abdominal pain and stool consistency. The main outcome measured is the percentage of days participants experience a significant improvement in their symptoms during weeks 9 to 16. Researchers will also monitor safety, side effects, and other symptom responses throughout the 24-week period. The study includes careful assessment of IBS-D criteria and symptom severity to evaluate treatment effects over time.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This phase 2 study focuses on how these medications work alone or in combination for people who have had UC for at least three months and have not responded well or tolerated previous treatments. The trial is sponsored by Eli Lilly and Company and aims to improve treatment options for this condition. Participants may receive eltrekibart alone, mirikizumab alone, both drugs together, or placebos in various combinations. The study uses a randomized, double-blind design to compare these different treatment groups. The trial lasts about 69 weeks, including a screening period up to 35 days before enrollment. Treatments are administered throughout the study, with doses adjusted as needed to assess safety and effectiveness. During the trial, participants will undergo regular assessments including clinical remission rates at 12 and 52 weeks, endoscopic and histologic evaluations, and quality of life questionnaires. Blood tests will measure drug levels to monitor pharmacokinetics. Safety and response to treatment will be closely monitored throughout the study, which spans approximately 4 to 5 years in total. Participants will have multiple visits for evaluations to track their progress and any side effects.

Researchers are evaluating the safety and effectiveness of a drug called LY4395089, which activates the farnesoid X receptor (FXR), when given together with mirikizumab compared to mirikizumab alone. This study focuses on adults with moderately to severely active Crohn's disease and is part of a larger research effort known as the IIBD master protocol. The study will last about 62 weeks and aims to better understand treatment options for Crohn's disease. Participants will be randomly assigned to one of two groups. In the first study period, one group will receive mirikizumab through an intravenous (IV) infusion, while the other group will receive both LY4395089 orally and mirikizumab IV. Responders to treatment will then move to the second study period where they will stop LY4395089 and continue receiving mirikizumab as a subcutaneous (SC) injection. During the study, participants will be closely monitored with evaluations to measure their response, including the percentage of participants achieving an endoscopic response by week 12. Other assessments will track clinical remission and changes in fecal calprotectin. The study involves multiple visits and procedures over the course of about 62 weeks to carefully assess the treatments' effects and safety.

Researchers are studying adults with moderate to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), which are long-term gut conditions causing symptoms like diarrhea, inflammation, bleeding, and belly pain. The study aims to evaluate how many participants achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 trial sponsored by Takeda, focused on treatment in a community setting. Participants will receive Vedolizumab initially as an intravenous infusion at weeks 0 and 2. Around week 6, participants may switch to subcutaneous injections every two weeks until week 50. Some participants might receive an additional intravenous dose at week 6 before switching. Those whose treatment does not seem effective by week 14 may stop and switch to other therapies. Additional visits occur at weeks 26 and 52, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit their clinic multiple times for assessments. Researchers will measure remission rates using patient-reported outcomes at various points, including weeks 6, 14, and 52. Other evaluations include clinical responses, endoscopic improvements, and changes in inflammation markers like C-reactive protein and fecal calprotectin. Safety is monitored by tracking infections and adverse events up to 72 weeks, ensuring comprehensive follow-up over approximately one year.

Researchers are evaluating the effectiveness and safety of induction therapy using Afimkibart (RO7790121) in people with moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled trial aims to understand how well this treatment works compared to placebo during the induction phase. The study focuses on participants who have not responded adequately to other conventional or advanced therapies for Crohn's disease. Participants will be randomly assigned to receive either Afimkibart through an intravenous (IV) infusion followed by subcutaneous (SC) injections or a placebo IV infusion followed by Afimkibart SC injections. This treatment schedule is designed to assess the induction effectiveness of Afimkibart in reducing disease activity over a 12-week period. The study includes two treatment groups to compare outcomes between the active drug and placebo. During the study, participants will be monitored for clinical remission and endoscopic response at week 12, along with other measures such as symptomatic remission, bowel urgency, abdominal pain, stool consistency, fatigue, and quality of life questionnaires. Safety assessments will continue for up to 30 weeks after baseline to record any adverse events. Participants will attend scheduled visits for evaluations and laboratory tests to track progress and response to treatment throughout the trial.

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in patients aged 1 to under 31 years with first relapse of CD19+ B-cell acute lymphoblastic leukemia (B-ALL), including those with Down syndrome. This phase II trial aims to compare event-free survival and remission rates, as well as assess safety and tolerability of these treatments in this patient group. Treatment involves several groups and arms with different combinations of drugs including dexamethasone, blinatumomab, nivolumab, methotrexate, and others. Some groups receive pre-immunotherapy treatments depending on disease characteristics. Treatment cycles last about 36 to 37 days and may repeat up to two cycles unless disease progression or unacceptable toxicity occurs. Radiation therapy and various chemotherapy regimens are also part of the treatment for certain patients. Participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collections of blood, urine, and cerebrospinal fluid throughout the study. After treatment completion, they are followed up every 3 months for 1 year. The main results measured include minimal residual disease-negative remission rates and event-free survival. Safety, adverse events, and other clinical factors are closely monitored during and after treatment.