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Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are investigating treatments for oligodendrogliomas, a type of brain tumor classified by specific genetic markers including mutations in isocitrate dehydrogenase IDH and co-deletion of chromosomes 1p19q. This trial focuses on adults with newly diagnosed grade 2 or 3 gliomas, aiming to improve survival without loss of brain function, cognition, or quality of life. The study compares two treatment approaches to determine the best timing and combination of chemotherapy and radiotherapy. Participants are randomly assigned to receive either standard chemoradiation with procarbazine, CCNU lomustine, and vincristine PCV combined with radiotherapy, or an experimental approach starting with chemotherapy using lomustine and temozolomide CETEG followed by radiotherapy and PCV at tumor progression. Radiotherapy is delivered over about 5 to 6 weeks, with doses adjusted for tumor grade. Chemotherapy cycles last 6 weeks and include specified doses of oral and intravenous drugs. During the study, participants undergo regular magnetic resonance imaging MRI scans every three months, neurological assessments, quality of life questionnaires, and cognitive testing annually. The main outcome measured is qualified overall survival, which tracks survival without significant cognitive or functional decline. The study lasts up to 10 years, with ongoing monitoring of tumor progression, treatment response, and patient wellbeing. Safety and side effects are carefully assessed throughout the trial.

This research is an international multicenter retrospective observational study focusing on patients with Essential Thrombocythemia ET who are positive for the JAK2V617F mutation. It aims to understand the progression from ET to Polycythemia Vera PV and compare clinical outcomes between those who progressed and those who did not, using criteria defined by the International consensus classification of myeloid neoplasms and acute leukemias from 2022. The study consists of two parts a nested case-control study and a comparative retrospective cohort study. The first part compares ET patients who progressed to PV with matched ET patients who did not progress, based on diagnosis year, age at diagnosis, and disease duration. The second part compares patients diagnosed with de novo PV without prior ET to the ET-to-PV cases, again matched by diagnosis year, age, and disease duration. All patients included in the study were diagnosed by the end of 2020 to allow at least 5 years of follow-up. Participants will have their medical histories reviewed retrospectively to analyze clinical data up to the baseline and at the time of progression. Researchers will assess phenotypic changes and clinical outcomes between groups, with no new treatments or interventions administered. The study is observational and aims to gather information from existing records to better understand disease evolution over time.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

This observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.

Researchers are comparing INCA033989 with the best available therapy for adults who have essential thrombocythemia ET with a CALR mutation and have previously received cytoreductive treatment. The study aims to evaluate the effects of these treatments on this specific patient group. It is a Phase 3 clinical trial sponsored by Incyte Corporation to assess treatment responses and safety. Participants will be randomly assigned to receive either INCA033989 administered intravenously or the best available therapy chosen by their doctor. The treatments are given according to the study protocol. The study focuses on treatment outcomes over a period of weeks, including response durability and symptom changes, with assessments at specified timepoints. During the study, participants will have regular visits to monitor their clinical and hematologic responses, symptoms, and any side effects. Researchers will collect data on mutation levels, symptom questionnaires, and fatigue assessments up to 48 weeks. Safety monitoring will continue for 60 days following the last dose. The total duration of participation may extend up to several months as outlined by the trial schedule.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are evaluating the combination of Surovatamig AZD0486, a fully human bispecific monoclonal IgG4 antibody, plus rituximab versus standard immunochemotherapy regimens in adults with untreated follicular lymphoma FL. This global, randomized, open-label Phase III study aims to assess the efficacy, safety, and added benefit of this combination compared to investigator-chosen standard treatments. The study includes a safety run-in and a Phase III portion with three treatment arms. The study has two parts first, a Safety Run-in to determine the recommended Phase III dose RP3D of Surovatamig combined with rituximab second, a Phase III comparison of Surovatamig plus rituximab two dosing schedules against one of three standard chemoimmunotherapy regimens chosen by the investigator R-CVP, R-CHOP, or B-R, all followed by rituximab maintenance. Participants are assigned to one of these three arms to evaluate treatment effects. Participants will be monitored for up to 10 years, with assessments including adverse event tracking, dose adjustments, and efficacy measures such as response rates, progression-free survival, and overall survival. Evaluations involve physical exams, laboratory tests, and imaging to measure disease activity and safety. The study aims to gather long-term data on treatment impact and safety in this patient population.

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.