Aomori

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating whether baricitinib can delay the development of clinical stage 3 type 1 diabetes T1D in children and adults at high risk. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or specific diabetes-related autoantibodies. The study aims to better understand preventing or delaying the onset of clinical diabetes in this at-risk population. Participants will be randomly assigned to receive either baricitinib or a placebo orally. The study lasts up to approximately 5 years, during which participants take the assigned treatment and are monitored regularly. The trial includes a control group receiving placebo to compare with the baricitinib group. The dosing schedule and exact treatment duration depend on the study protocol and participant response. Throughout the study, participants will undergo assessments including monitoring the time to diagnosis of stage 3 T1D, blood tests measuring glucose and C-peptide levels, body measurements, and health surveys. Researchers will track changes in these measures over time, including pharmacokinetics of baricitinib. Safety and response to treatment will be closely observed throughout the study duration to evaluate the effects of the medication.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating the safety and effectiveness of ONO-2020 in adults aged 55 to 90 years with agitation linked to Alzheimers Disease dementia. This phase 2a, randomized, placebo-controlled study is conducted across multiple centers in Japan and aims to better understand how ONO-2020 affects agitation symptoms in this population. Participants will be randomly assigned to receive either two ONO-2020 tablets or two placebo tablets once daily. The treatment period lasts up to 12 weeks, during which patients are hospitalized from 21 days before treatment starts through the treatment phase. The study is designed as a double-blind, parallel-group trial to compare ONO-2020 against placebo. Throughout the study, researchers will monitor changes in agitation using the Cohen-Mansfield Agitation Inventory CMAI and assess safety through vital signs, ECG measurements, laboratory tests, and the Columbia-Suicide Severity Rating Scale. Additional assessments include cognitive function tests and daily living activity scores. The study will continue safety monitoring up to 16 weeks, with the primary evaluation of agitation changes by week 12.

Researchers are evaluating oral Nuvisertib TP-3654, a PIM inhibitor, in a Phase 12 open-label trial for patients with intermediate or high-risk primary or secondary myelofibrosis. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Nuvisertib. Participants include those who have been previously treated with JAK inhibitors, those currently on ruxolitinib with suboptimal response, and patients treated with other JAK inhibitors except momelotinib. The trial includes three treatment arms Nuvisertib alone, Nuvisertib combined with ruxolitinib, and Nuvisertib combined with momelotinib. Patients will receive oral doses with dose escalation to determine safe and effective levels. Each arm enrolls specific patient groups based on prior treatments and response. The study monitors drug effects and interactions when used alone or in combination with other JAK inhibitors. Participants will be closely monitored for dose-limiting toxicities, adverse events, spleen volume reduction, symptom improvement, and other pharmacokinetic measures. Regular assessments include symptom scoring, imaging scans for spleen size, laboratory tests, and cardiac monitoring. The study duration and follow-up extend to evaluate both safety and preliminary activity, with careful tracking of treatment effects over time.

This trial investigates the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. It compares the effects of empasiprubart and intravenous immunoglobulin IVIg to evaluate which treatment may better reduce symptoms and improve function in people with CIDP. The study is a Phase 3, randomized, double-blind trial designed to assess both efficacy and safety of these treatments over an extended period. Participants are randomly assigned in Part A to receive either empasiprubart with a placebo resembling IVIg or IVIg with a placebo resembling empasiprubart for 24 weeks 6 months. After Part A, all participants enter Part B, where they receive empasiprubart for an additional 96 weeks 24 months. During Part B, those previously receiving empasiprubart continue with it, and those initially on IVIg switch to empasiprubart. Treatments are administered by intravenous infusion using a double-dummy design to maintain blinding. Throughout the study, participants undergo regular assessments of their disability, strength, grip, and quality of life using various scales such as aINCAT, I-RODS, MRC-SS, and others. Safety is monitored by tracking adverse events and antibody formation against empasiprubart. The primary outcome is the reduction of at least one point in the aINCAT score at week 24. Total participation lasts up to 120 weeks, including both treatment periods, with ongoing evaluations to understand the long-term effects of empasiprubart.

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.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of sefaxersen RO7434656, a new Antisense Oligonucleotide ASO therapy, in adults with primary IgA nephropathy IgAN who are at high risk of worsening kidney disease despite receiving optimized supportive care. This phase III study focuses on participants who continue to face disease progression despite standard treatments. Participants will receive subcutaneous injections of either sefaxersen or a matching placebo. The dosing schedule includes injections on Days 1, 15, and 29, followed by doses once every four weeks until Week 105. After Week 105 or the primary data cut-off, eligible participants may switch to open-label sefaxersen treatment at the investigators discretion. Throughout the study, participants will undergo assessments to measure changes in urine protein-to-creatinine ratio at Week 37, kidney function eGFR slope at Week 105, and monitor for hematuria resolution, kidney failure events, fatigue, and treatment-emergent adverse events. Blood samples will be collected to measure plasma sefaxersen levels. The total study duration extends up to approximately 36 months, with ongoing safety and efficacy monitoring.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.