Tachikawa

Researchers are evaluating the effectiveness of JNJ-95597528 compared to a placebo in adults with moderate to severe atopic dermatitis, a chronic skin condition. This Phase 2b study aims to assess how well JNJ-95597528 works in improving symptoms in participants who have had the condition for at least one year and meet specific disease severity criteria. JNJ-95597528 and placebo will both be given by subcutaneous injection. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will receive their assigned treatment and be monitored throughout the study to evaluate the drug's impact on their skin condition. Participants will be involved in scheduled visits where their eczema severity will be assessed using the Eczema Area and Severity Index (EASI) among other measures. The primary outcome is the proportion of participants achieving a 75% improvement in EASI at Week 12. Safety and adherence to the treatment plan will also be monitored during the study period.

Researchers are evaluating the effectiveness and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

Researchers are evaluating the safety and effects of ritlecitinib for treating chronic spontaneous urticaria (CSU) in adults whose condition is not well controlled by antihistamines. CSU causes itchy hives and swelling under the skin without a clear cause. This Phase 2b study compares two oral doses of ritlecitinib, 50 mg and 100 mg, with a placebo to understand if these doses are safe and effective in managing symptoms. Participants will be randomly assigned to take either 50 mg, 100 mg, or placebo capsules once daily for 12 weeks (Period A). After this, those on ritlecitinib will continue their assigned dose while those on placebo will switch to 100 mg for another 12 weeks (Period B). The study involves about 150 adult participants and compares the effects of the two ritlecitinib doses against placebo over these two 12-week periods. Participants will be involved in the study for about 8 months with up to 9 visits to the study site. During visits, they will have physical exams, hearing tests, blood tests, X-rays, and ECGs. They will also complete daily questionnaires about their urticaria symptoms using an electronic diary. Researchers will measure changes in urticaria activity and monitor for any treatment-related side effects or adverse events throughout the study.

This research aims to evaluate the safety and effectiveness of a medicine called ibuzatrelvir, alone and combined with remdesivir, compared to remdesivir alone in adults who have symptomatic COVID-19 and are severely immunocompromised. Immunocompromised patients often have difficulty fighting infections and may face persistent or severe COVID-19 illness. The study is a Phase 3, randomized, double-blind trial involving adult participants who are either non-hospitalized or hospitalized for observation but do not need supplemental oxygen for COVID-19. Participants will be randomly assigned to one of three groups: one receiving remdesivir alone, one receiving ibuzatrelvir alone, and one receiving both ibuzatrelvir and remdesivir. Ibuzatrelvir is taken orally twice daily, while remdesivir is given by daily intravenous infusion. Placebo tablets and injections will be used to keep the treatment groups visually similar. The study compares how participants respond to ibuzatrelvir with or without remdesivir versus remdesivir alone. Participants will attend around 10 study visits over 24 weeks, which include clinic visits, blood tests, and nasal swabs collected both in the clinic and by participants at home. They will also complete questionnaires. Researchers will measure the proportion of patients who meet the primary outcome after 38 days and monitor safety throughout the study.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Researchers are evaluating the safety and effectiveness of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin (CPUO), a condition causing severe itching without a known cause. This master protocol includes two parallel, double-blind, placebo-controlled Phase 3 studies (Study A and Study B) designed to assess dupilumab's impact on reducing itch severity. Both studies involve participants experiencing severe itch despite prior treatments and exclude those with pruritus caused by other known conditions. Participants first undergo up to a 4-week screening period, followed by a 4-week run-in phase where they receive a non-sedative antihistamine and an emollient. Those with severe itch at baseline are then randomly assigned to receive either subcutaneous dupilumab or a matching placebo for 24 weeks, alongside the antihistamine and emollient. After treatment, a 12-week follow-up phase monitors participants. Study durations for both studies can last up to 44 weeks per participant. During the study, participants are assessed for changes in itch severity using the worst-itch numerical rating scale (WI-NRS) and patient global impression of severity (PGIS). Researchers track the proportion of participants who achieve significant itch reduction by Week 24 in Study A and by Week 12 in Study B. Safety and efficacy are monitored throughout treatment and follow-up, with participant involvement including regular evaluations, questionnaires, and adherence to the assigned treatment regimen.

Researchers are evaluating the effect of oral venetoclax on adult participants with relapsed or refractory Waldenstrf6m macroglobulinemia (WM) or lymphoplasmacytic lymphoma (LPL), which are rare types of low-grade B-cell lymphoma. The study aims to assess changes in disease activity in this group, focusing on those who have already received at least one prior standard therapy. This is a Phase 2 study conducted at approximately 20 sites in Japan, involving about 14 adult participants. Participants will receive oral venetoclax, with doses gradually increased to reach the target dose as part of their treatment. The study treatment period will last up to approximately 28 months. Throughout the study, participants will attend regular visits at hospitals or clinics for treatment and monitoring. The study recognizes that the treatment burden may be higher compared to standard care. During the study, researchers will monitor disease activity and treatment effects through medical assessments, blood tests, and evaluating side effects. Key outcomes include the number of participants who achieve a major response. Participants must have measurable disease and adequate organ and bone marrow function. The total study duration is about 28 months, during which safety and treatment response will be closely observed.