Shimizu

Researchers are evaluating a new form of hormone therapy called ASP5541 for men with advanced prostate cancer that has spread to other parts of the body. This phase 2 study compares ASP5541 given by injection with the standard abiraterone acetate tablets, both combined with a steroid called prednisone or prednisolone. The study aims to assess how well ASP5541 works and its safety in men who have not previously been treated with androgen receptor pathway inhibitors, including specific evaluation in Japanese men. Participants are divided into three groups based on their cancer type and treatment history. ASP5541 is given as a muscle injection every 12 weeks, while abiraterone acetate is taken as a daily tablet. Men with metastatic castration-resistant prostate cancer take prednisone or prednisolone twice daily, and men with metastatic hormone-sensitive prostate cancer take it once daily. All groups also receive standard care such as androgen deprivation therapy. Some participants will monitor blood pressure at home weekly. During the study, men visit the clinic regularly for health checks, safety monitoring, and scans to observe any changes in their cancer. The frequency and type of visits depend on each participants health and treatment stage. Researchers will measure prostate-specific antigen PSA levels, adverse events, physical exams, ECGs, and performance status to evaluate treatment effects and safety. The study may last up to about 3 years for some outcomes, with longer follow-up for certain measures.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating ASP3082, a drug given by intravenous infusion, in adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. This open-label Phase 1 study aims to check the safety and tolerability of ASP3082 alone or combined with other treatments like cetuximab, FOLFIRINOX, Nab-Paclitaxel plus gemcitabine, docetaxel, pembrolizumab, platinum-based chemotherapy, and NALIRIFOX. Participants have tumors that have not responded to or are ineligible for standard therapies. The study consists of two parts. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab to find suitable doses. In Part 2, participants receive ASP3082 alone or combined with other study treatments at doses selected from Part 1. Treatments are given by infusion in cycles of 21 or 28 days. Participants continue treatment until intolerable side effects, disease progression, start of other cancer therapy, or withdrawal. Throughout the study, participants undergo regular monitoring for side effects, physical exams, lab tests, ECGs, and assessments of tumor response using standard criteria. Safety is tracked up to 48 months. Researchers collect tumor samples before and during treatment to study changes in the KRAS mutation. Participants overall health and performance status are also evaluated during the study, which may last several years depending on individual outcomes and treatment responses.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating how well JNJ-78934804 works and how safe it is compared to guselkumab in participants with moderately to severely active Crohns disease, a long-term and progressive condition affecting the intestine. This Phase 3 trial aims to assess clinical remission and endoscopic remission at Week 48, focusing on treatment efficacy and safety. Participants are randomly assigned to receive either JNJ-78934804 or guselkumab. Both treatments involve induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting at Week 12. Participants meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, with maintenance doses continuing every 4 weeks from Week 28. Those completing the double-blind phase at Week 48 may enter a long-term extension phase if the investigator believes they may benefit. During the study, participants will be monitored for clinical and endoscopic remission, deep remission, corticosteroid-free remission, and patient-reported outcomes up to Week 48. Researchers will also track adverse events for up to approximately three years. Assessments include symptom scores, endoscopy reviews, and quality-of-life questionnaires to evaluate the treatments effects and safety throughout the trial.

Researchers are evaluating the effectiveness and safety of JNJ-78934804 compared to guselkumab in people with moderately to severely active ulcerative colitis UC, a chronic condition where the colon lining becomes inflamed and develops ulcers. This Phase 3 study aims to measure clinical remission and other health improvements by Week 48. Participants receive an induction dose of either JNJ-78934804 or guselkumab at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting Week 12. Those meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, then maintenance doses every 4 weeks from Week 28. After completing the 48-week double-blind treatment phase, participants benefiting from the intervention may join a long-term extension phase. Throughout the study, participants will be monitored for clinical remission, endoscopic improvement, corticosteroid-free remission, fatigue, abdominal pain, quality of life, and mental health responses. Safety is assessed by tracking adverse events up to about 3 years. The study involves randomized assignment and double-blinding, with all treatments given by subcutaneous injection. Participation may last up to several years including follow-up and extension phases.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the combination of Trastuzumab Deruxtecan T-DXd with bevacizumab compared to bevacizumab alone as a first-line maintenance therapy in adults with advanced high-grade epithelial ovarian cancer that expresses HER2. This Phase 3 trial includes a safety run-in phase to check how well participants tolerate T-DXd combined with bevacizumab before randomization. The study focuses on participants newly diagnosed with FIGO Stage III or IV ovarian, fallopian tube, or primary peritoneal carcinoma, who have HER2 expression confirmed by central testing. Participants are assigned to one of two groups one receiving T-DXd at 5.4 mgkg intravenously every 3 weeks plus bevacizumab at 15 mgkg intravenously every 3 weeks, and the other receiving bevacizumab alone at the same dose and schedule. Before randomization, a safety run-in phase will assess the safety of the combination treatment. The study is open-label and multicenter, designed to compare the treatments as first-line maintenance therapy after initial chemotherapy. During the trial, participants will be closely monitored through radiographic assessments to measure progression-free survival and overall survival, particularly focusing on HER2 expression levels. Researchers will evaluate safety and effectiveness over follow-up periods of up to approximately 35 and 72 months, respectively. Tumor tissue samples and genetic testing results will be collected to support evaluations. Participant involvement includes signing informed consent, undergoing central HER2 testing, and regular treatment and monitoring visits throughout the study duration.