Yamanashi

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 the effects of TAK-226 on symptoms of transfusion-dependent anemia in Japanese adults with lower-risk myelodysplastic syndromes MDS. This Phase 2, open-label study focuses on patients classified as very low, low, or intermediate risk according to a specific scoring system. The trial aims to understand how TAK-226 may improve anemia-related symptoms and reduce the need for blood transfusions in this population. Participants receive TAK-226 through subcutaneous injections every four weeks for about one year during the Treatment Period. The study begins with a Screening Period lasting up to six weeks to confirm eligibility. After treatment, participants enter an 8-week Safety Follow-Up Period to monitor side effects, followed by a Long-Term Follow-Up Period lasting up to five years from the first dose or three years after the last dose, whichever is longer. During the Treatment Period, participants visit the clinic approximately every two to four weeks. Throughout the study, participants undergo regular visits for assessments including blood tests and evaluations of hemoglobin levels and transfusion needs. Researchers will monitor various blood parameters and adverse events up to about six years. The primary outcomes focus on achieving transfusion independence or meaningful increases in hemoglobin over periods of up to 24 weeks. Overall, participants may be involved in the study for up to six years, allowing long-term observation of treatment effects and safety.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are evaluating the use of belimumab, in addition to standard therapy, for adults with interstitial lung disease ILD linked to connective tissue diseases CTDs such as rheumatoid arthritis and systemic lupus erythematosus. ILD causes lung inflammation and stiffness, leading to symptoms like shortness of breath and fatigue, and is a leading cause of death in people with these conditions. The study aims to see if belimumab can stabilize or improve lung function and symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both alongside their usual standard therapy. Belimumab is administered subcutaneously, and the study is designed as a phase 3, double-blind, placebo-controlled trial. The treatment period lasts 52 weeks, during which lung function and symptoms will be closely monitored. Participants will have assessments including lung function tests measuring forced vital capacity, symptom questionnaires, and imaging scans at the start and after 52 weeks. Researchers will also track safety by monitoring adverse events and hospitalizations related to respiratory issues. The overall study duration includes these evaluations up to 52 weeks to understand the treatments impact on lung disease progression and patient well-being.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

This research aims to evaluate the efficacy and safety of belantamab mafodotin given with standard cancer treatments in adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or is not responding to prior treatments. The study focuses on whether giving belantamab mafodotin less frequently can still control the cancer while reducing side effects, especially those affecting the eyes. It is a phase 2, open-label study sponsored by GlaxoSmithKline. Participants will receive belantamab mafodotin combined with one of three standard treatment regimens pomalidomide and dexamethasone bortezomib and dexamethasone or carfilzomib and dexamethasone. The study uses an extended dosing schedule to assess if less frequent dosing maintains effectiveness. The treatment continues as per the assigned combination, with no randomization, in multiple centers. During the study, participants will be regularly assessed for response to treatment, including overall response rate and complete response rate, up to about 52 months. Safety will be monitored by recording side effects and eye health through ophthalmic exams. Participants will undergo laboratory tests and clinical evaluations throughout the study. The research will also track how well patient-reported eye symptoms match clinical findings, with the total study duration extending up to approximately four years.

Researchers are evaluating depemokimab in adults with hypereosinophilic syndrome HES who have uncontrolled disease despite standard care therapy. This phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter study focuses on adults with confirmed HES diagnosis, a history of repeated flares two or more in the past 12 months, and a blood eosinophil count of at least 1,000 cellsL. The goal is to assess the efficacy and safety of depemokimab in reducing HES flares compared to placebo while continuing standard care treatment. Participants will be randomly assigned in a 21 ratio to receive either depemokimab or a matching placebo. Both groups will continue their stable standard of care HES therapy during the 52-week treatment period. Depemokimab or placebo is administered under blinded conditions, and participants will be monitored throughout the study to evaluate treatment effects and safety. Throughout the 52 weeks, participants will have regular assessments including monitoring the frequency and timing of HES flares, fatigue levels measured by the Brief Fatigue Inventory, and other safety evaluations. The primary outcome is the frequency of HES flares up to 52 weeks. Secondary outcomes include time to first flare, number of participants experiencing flares, and changes in fatigue scores. Safety and tolerability will also be closely monitored during the study period.

Researchers are conducting a survey to study patients who have received Ondexxya Intravenous Injection 200 mg to neutralize the anticoagulant effects of Factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. This observational study aims to monitor safety specifications such as thrombotic events, infusion reactions, and re-bleeding, while also understanding the drugs safety and effectiveness under real-world use. The survey collects information about the occurrence of unknown adverse drug reactions, the incidence of adverse reactions during routine use, and factors that might influence the drugs safety or effectiveness. There are no specific treatments or interventions administered as part of the study since it observes patients receiving routine care with Ondexxya. Participants will be monitored for 30 days to document adverse drug reactions and safety-related events, including how patient background factors may affect outcomes. Data collection involves safety and effectiveness information gathered during this period, with no additional procedures or visits beyond standard clinical care. The study is sponsored by AstraZeneca and will continue until October 2026.

Researchers are evaluating the efficacy and safety of ONO-2017 cenobamate combined with other antiepileptic drugs in Japanese patients who have primary generalized tonic-clonic seizures. This phase III, open-label study focuses on patients aged 12 years or older who experience frequent generalized seizures as part of idiopathic generalized epilepsy. Participants will take cenobamate orally once daily alongside one to three other fixed-dose antiepileptic medications. The study aims to observe changes in seizure frequency over a 12-week maintenance period while monitoring safety and tolerability. Throughout the study, researchers will track seizure frequency and reduction rates using 28-day intervals during the maintenance phase. Participants will be assessed regularly for seizure control and any side effects. The study will continue until January 2027, allowing for ongoing evaluation of treatment effects and safety.