Tachikawa

Researchers are evaluating the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

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 evaluating whether donanemab slows the progression of cognitive decline, which affects thinking, learning, memory, attention, and decision-making, as well as functional decline impacting daily activities. This study focuses on adults aged 55 to 85 who have early cognitive decline along with Lewy Body Dementia features and confirmed brain amyloid and alpha-synuclein pathology. The trial is a phase 2 treatment study sponsored by Eli Lilly and Company, lasting one and a half years per participant. Participants are randomly assigned to receive either donanemab or a placebo, both given as intravenous infusions. Donanemab is being studied to assess its effects compared to placebo in this population. The treatment period lasts for 52 weeks, during which participants receive regular infusions under medical supervision. During the study, participants will undergo various assessments including cognitive and functional tests such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Integrated Alzheimers Disease Rating Scale iADRS, and Alzheimers Disease Assessment Scale - Cognitive Subscale ADAS-Cog13. Brain imaging and cerebrospinal fluid analysis will also be performed to measure amyloid plaque levels and alpha-synuclein pathology. Safety and drug levels in blood will be monitored throughout, with participants being followed closely for one and a half years total.

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Researchers are evaluating the efficacy and safety of amlitelimab, given as a subcutaneous injection, for treating moderate-to-severe atopic dermatitis AD in participants aged 12 years and older. This Phase 3, randomized, double-blind, placebo-controlled study includes participants who have not responded adequately to prior biologic or oral Janus kinase inhibitor JAKi therapies while using background topical corticosteroids TCS. Participants are randomly assigned to one of three groups receiving subcutaneous injections of either one of two doses of amlitelimab or a placebo, all alongside background TCS therapy. The treatment period lasts up to 36 weeks, followed by either a 16-week safety follow-up for those not entering the long-term safety study or no further treatment period for those entering the extension study. The entire study duration ranges up to 56 weeks for participants not entering the long-term safety study and up to 40 weeks for those who do. Participants will attend up to 13 visits during the study, or 12 visits if they join the long-term safety study. Assessments include evaluating skin condition using standardized scales such as the Validated Investigator Global Assessment for AD and the Eczema Area and Severity Index. Researchers will monitor safety, side effects, skin symptoms, quality of life, and various patient-reported outcomes. Long-term safety and response to treatment will also be observed for those who continue into the extension study.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are evaluating the safety and effects of the medicine ritlecitinib for adults with chronic spontaneous urticaria CSU that is not well controlled by antihistamines. CSU causes itchy hives and swelling in the skin and fatty tissue without a clear cause. This phase 2 study aims to compare two oral doses of ritlecitinib, 50 mg and 100 mg, against a placebo to learn how well they work and their safety profiles. Participants will be randomly assigned to one of three groups taking 50 mg ritlecitinib, 100 mg ritlecitinib, or a placebo, each taken once daily by mouth for 12 weeks Period A. After this, those on ritlecitinib continue their doses for another 12 weeks Period B, while those initially on placebo switch to 100 mg ritlecitinib for the same duration. Placebo capsules matching the active doses will be given to maintain study blinding. Participants will be involved in the study for about 8 months and will visit the study site up to 9 times. During visits, they will have physical exams, hearing tests, blood tests, chest X-rays, and ECGs. They will also complete daily questionnaires about their symptoms using an electronic diary. The main outcome measured is the change in their urticaria activity score after 12 weeks, along with monitoring for any side effects or adverse events throughout the study.

Researchers are evaluating the effects of a study medicine called ibuzatrelvir, alone and in combination with remdesivir, for treating symptomatic COVID-19 in adults who are severely immunocompromised. This Phase 3 clinical trial compares ibuzatrelvir with remdesivir to remdesivir alone to assess safety and effectiveness in non-hospitalized or hospitalized patients who do not require supplemental oxygen. Immunocompromised patients often have difficulty fighting infections and may benefit from extended or combination antiviral treatments. Participants are randomly assigned to one of three groups one receiving both ibuzatrelvir taken orally twice daily and intravenous remdesivir, one receiving ibuzatrelvir with a placebo infusion, and one receiving remdesivir with a placebo pill. Placebos that look like the study medicines are used to keep the groups similar in appearance. This design helps researchers determine if adding ibuzatrelvir improves treatment compared to remdesivir alone. Participants will attend about 10 study visits over 24 weeks, including clinic visits for blood tests, nasal swabs collected both at the clinic and at home, and questionnaires. Researchers will measure outcomes such as symptom improvement, viral levels, COVID-19-related healthcare visits, and safety events. The study carefully monitors participants throughout to understand the treatment effects and safety over time.