Bodman Ludwigshafen

Researchers are investigating new treatments for adults with moderately to severely active ulcerative colitis or Crohns disease under a master protocol called Study IIBD. This Phase 2 trial evaluates multiple drugs to understand their safety and effectiveness in managing these conditions. Participants will be assigned to specific sub-studies and randomized to treatment groups, with the study lasting at least 62 weeks. The study includes two treatment periods. In the first period, participants may receive mirikizumab intravenously, or a combination of the oral drug LY4395089 with intravenous mirikizumab. Those who respond to treatment will then enter a second period where they receive mirikizumab through subcutaneous injections. These steps allow researchers to assess different dosing methods and combinations of these drugs. Participants will be monitored regularly throughout the study, including screening tests and laboratory evaluations to ensure eligibility and safety. Researchers will track the number of participants allocated to each treatment group up to day 42 as a primary outcome. The study involves randomization without masking and continues until at least 62 weeks, with ongoing assessments to evaluate treatment effects and monitor health outcomes.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

This trial investigates the safety and effectiveness of combining a drug called LY4395089, which is a farnesoid X receptor FXR agonist, with mirikizumab compared to using mirikizumab alone in adults who have moderately to severely active Crohns disease. This Phase 2 study is part of a larger research protocol focused on inflammatory bowel diseases and will last about 62 weeks. Participants are assigned to one of two groups. In the first study period, one group receives mirikizumab via intravenous IV infusion, while the other group receives both LY4395089 orally and mirikizumab IV. In the second study period, participants who respond to treatment will stop LY4395089 and receive mirikizumab subcutaneously SC. This design allows comparison of the combined treatment versus mirikizumab alone. Throughout the study, participants will undergo assessments including endoscopic evaluations to measure Crohns disease response up to Week 12, clinical remission checks, and fecal calprotectin tests to monitor inflammation. The study includes regular visits for treatment administration and monitoring, with the total participation lasting approximately 62 weeks. Safety and efficacy are closely observed during the trial.

Researchers are evaluating whether combining vedolizumab and upadacitinib, called dual targeted therapy DTT, reduces bowel inflammation and ulcers more effectively than vedolizumab alone in adults with moderately to severely active Crohns Disease CD. The study also compares the safety and effectiveness of these treatments. This Phase 3b trial is conducted worldwide and sponsored by Takeda, enrolling about 396 participants. Participants are randomly assigned to receive either vedolizumab with upadacitinib or vedolizumab with a placebo for 12 weeks during the Induction Phase. Vedolizumab is given as a 300 mg intravenous infusion at Weeks 0, 2, 6, and 10 upadacitinib or placebo is taken daily by mouth. Those who respond to treatment at Week 12 will continue with vedolizumab alone every 8 weeks for 40 weeks in the Maintenance Phase. Vedolizumab dosing frequency may increase to every 4 weeks if needed. During the approximately 70-week study, participants visit the clinic 15 times for assessments including clinical evaluations, endoscopic exams, and patient-reported outcomes. Researchers measure clinical remission, endoscopic response, and safety outcomes at Week 12 and Week 52. There is also an 18-week safety follow-up after the maintenance period to monitor participants health.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Researchers are evaluating the Symani Surgical System for safety and effectiveness in repairing sensory nerve injuries in the fingers. This study focuses on adults aged 18 to 70 with traumatic nerve damage distal to the carpal tunnel, treated by nerve suturing. The main goal is to assess nerve function recovery using the two-point discrimination test six months after surgery, while also monitoring serious events during the operation. Participants will be randomly assigned to one of two groups one receiving nerve repair with the robotic-assisted Symani Surgical System and the other undergoing manual nerve suturing by a surgeon. Both groups include participants who may have hybrid procedures combining robotic and manual techniques. Surgery must occur within 10 days of injury, and the study includes follow-up assessments up to 12 months post-procedure. During the study, participants will return for multiple evaluations measuring nerve sensitivity, hand and thumb strength, finger motion, and functional hand use at 3, 6, and 12 months after surgery. Safety is monitored by tracking serious adverse events during surgery. Overall, the study aims to understand how well robotic-assisted surgery compares to manual surgery for peripheral nerve repair, with participant involvement lasting at least one year after the operation.

Researchers are evaluating FWY003 in adults aged 50 and older with geographic atrophy GA caused by age-related macular degeneration AMD. The study aims to understand the relationship between different doses of FWY003 and their effects on the size of GA lesions, as well as the safety and overall effectiveness of the treatment compared to a placebo. This is a randomized, multi-center, double-masked Phase 2 trial designed to gather detailed information about dosing and outcomes. Participants are randomly assigned to one of four groups receiving either one of three dose levels of FWY003 or a placebo. The treatment period lasts 18 months, during which doses are administered and monitored regularly. The study includes extensive assessments of visual function using various eye tests and imaging to measure changes in GA lesion areas. Blood samples are also collected to measure FWY003 levels. Throughout the study, participants undergo periodic evaluations including eye exams, imaging, and visual acuity tests to track changes in their condition and monitor for any adverse effects. Safety is closely observed from the first dose through month 19. The primary measurement is the change in GA lesion size over 18 months. Participants are followed for the full duration of the trial, which lasts until 2029, ensuring comprehensive monitoring of treatment effects and safety.