Habikino

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 studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

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.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are evaluating the effectiveness and safety of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin CPUO, a condition causing severe itch without a known cause. This Phase 3 study involves two parallel double-blind trials, Study A and Study B, designed to assess dupilumabs impact on severe itch compared to placebo while participants also use non-sedative antihistamines and moisturizers. The study includes a screening period, a run-in period, and treatment followed by a follow-up. Participants will first undergo up to 4 weeks of screening, then a 4-week run-in period during which they receive non-sedative antihistamines and emollients. Those with severe itch scores will be randomly assigned to receive either dupilumab or placebo injections every two weeks for 24 weeks, alongside their antihistamine and moisturizer regimen. After treatment, participants will be followed up for 12 weeks to monitor ongoing effects and safety. During the study, participants will have regular assessments of their itch severity using a worst-itch numerical rating scale, quality of life questionnaires, and mental health evaluations. Researchers will monitor adverse events and immune responses to the drug. The total participation lasts up to 44 weeks, including screening, treatment, and follow-up, to evaluate changes in itch severity, sleep disturbance, and overall well-being.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are investigating multiple investigational compounds in adults with moderate to severe atopic dermatitis AD to assess their effectiveness and safety. This multicenter, randomized, double-blind, placebo-controlled Phase II platform study focuses on evaluating these treatments, with the initial compound being GHZ339. The study aims to better understand potential new options for managing moderate to severe AD. Participants will be randomly assigned to receive one of several doses of GHZ339 or a matching placebo during the first treatment period. Those receiving GHZ339 at specific doses in the first period will continue with the same or adjusted dose in the second treatment period, while those initially on placebo will receive GHZ339 at dose A in the second period. This design allows comparison of different doses and placebo effects across two treatment periods. During the study, participants will be monitored for changes in their eczema severity using the Eczema Area and Severity Index EASI score and other assessments like the Investigator Global Assessment IGA at baseline and Week 16. The study includes regular evaluations to track safety and treatment impact. Total participation duration includes screening, two treatment periods, and follow-up, with detailed monitoring to understand treatment effects and safety in this population.

This research observes patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors, excluding colorectal cancer, to monitor the safety and effectiveness of dabrafenib and trametinib. It is a prospective, multicenter, single-arm, non-interventional observational study that collects real-world data under current medical practices. The study is conducted using an electronic data capture system and aims to gather long-term information especially in pediatric patients. Participants receive dabrafenib and trametinib as prescribed according to the Japanese Package Insert without treatment assignment by the study. Adult patients are observed for one year after starting treatment, while pediatric patients are followed for up to eight years regardless of whether they continue treatment, to collect extensive safety and response data during the reexamination period. The study aims to include approximately 65 adults and about 20 pediatric patients. During the study, researchers collect data on adverse events related to skeletal and sexual maturation in pediatric patients, overall response rate in adults, progression-free survival, changes in height and weight, and other safety outcomes. Data collection occurs throughout the observation periods for both adult and pediatric patients. The study is sponsored by Novartis Pharmaceuticals and is designed to provide important long-term safety and effectiveness information on these medications used in routine care.