Munster

Researchers are evaluating the effectiveness, how the body processes the drug, and safety of remibrutinib compared to a placebo in adolescents aged 12 to less than 18 years with chronic spontaneous urticaria not well controlled by H1-antihistamines. The study also aims to collect long-term data on the drugs safety, tolerability, and effectiveness after 24 weeks of treatment and monitor safety up to three years after the last dose. The trial includes three periods a 24-week double-blind, randomized core period where two-thirds of participants receive remibrutinib orally twice daily and one-third receive placebo, followed by an optional open-label extension where participants who completed the core period may receive remibrutinib for up to six cycles of 24 weeks or enter a treatment-free observational period for up to one year, with options to switch based on symptoms. A further optional long-term treatment-free follow-up lasts up to three years with limited visits. Participants will have about 10 site visits during the core period and between 3 and 15 visits during the extension depending on symptoms, plus annual follow-up visits and phone calls during the long-term follow-up. Researchers will assess changes in urticaria activity and severity scores at baseline and week 12, monitor drug levels in the blood, track adverse events, and evaluate quality of life. Safety and symptom control are closely monitored throughout all study periods.

Researchers are evaluating the effects of delgocitinib cream 20 mgg applied twice daily compared to a non-active cream vehicle in adults aged 18 years and older with mild to severe palmoplantar pustulosis PPP. This skin condition involves pustules on the palms and soles and can persist for more than three months. The study aims to determine if delgocitinib improves the severity and symptoms of PPP over 16 weeks. Participants will be randomly assigned to one of two groups one applying delgocitinib cream twice a day and the other applying a matching vehicle cream twice a day, both for 16 weeks. The study is double-blind, meaning neither participants nor researchers know which treatment is given. The total study duration for each participant is about 18 weeks, including approximately 9 visits. During the study, participants will attend regular visits where their skin condition will be evaluated using several measures, including the Palmoplantar Pustulosis Area and Severity Index PPPASI and Physician Global Assessment PGA. Researchers will also assess symptoms like pustule counts, itch, pain, quality of life, and work productivity. Safety and any side effects will be monitored throughout the study period.

Researchers are evaluating litifilimab BIIB059, a monoclonal antibody, in adults with active cutaneous lupus erythematosus CLE. This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus SLE, who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after previous therapy. This study compares the effects of two oral drug combinations belzutifan plus zanzalintinib versus cabozantinib. The aim is to find out if the combination of belzutifan and zanzalintinib helps patients live longer overall and delays cancer progression compared to cabozantinib alone. Participants in this study will be randomly assigned to one of two groups. One group will take belzutifan and zanzalintinib orally once daily, while the other group will take cabozantinib orally once daily. Treatment will continue until certain conditions require stopping. This is an open-label, phase 3 trial evaluating these treatments in people with advanced RCC who have had disease recurrence during or after prior anti-PD-1L1 therapy. During the study, participants will be monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also track response rates, duration of response, side effects, and quality of life using questionnaires over about 25 months. Safety assessments and regular evaluations will be performed as part of the study. Total study participation may last several years, depending on individual circumstances and treatment continuation.

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC that tests positive for human papillomavirus 16 HPV16 and expresses the protein PD-L1. This Phase IIIII trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 years who have early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia. The study is a phase III trial designed to compare trontinemab with a placebo to better understand its impact on cognitive decline in Alzheimers patients. Participants will be randomly assigned to receive either intravenous IV trontinemab or an IV placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Treatment and monitoring will continue for 72 weeks, during which various cognitive and biological measures will be assessed. Throughout the study, participants will undergo regular assessments including cognitive tests like the Clinical Dementia Rating, Sum of Boxes CDR-SB, and the Mini-Mental State Examination MMSE. Brain imaging scans such as amyloid and tau PET scans, as well as MRI, will be used to observe changes in brain pathology. Researchers will also monitor safety by tracking adverse events, infusion reactions, and the presence of antibodies against trontinemab. Participants will be supported by a study partner and will be closely followed during the entire study period.

Researchers are evaluating KUP-101A, a drug given by intravenous infusion, in patients with certain advanced solid tumors including cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma of the skin, and basal cell carcinoma of the skin. This Phase 1 trial aims to find the highest dose of KUP-101A that patients can tolerate and to assess its safety and how it behaves in the body. Researchers will also gather initial data on how well KUP-101A works for these patients. Participants will receive KUP-101A at increasing dose levels, starting from Dose level 1 up to Dose level 7, to determine the recommended dose for further studies. The drug is given through infusion into a vein. The study is not randomized or blinded, meaning all participants receive the investigational treatment. The trial will monitor patients from enrollment and during treatment to observe any side effects, dose-limiting toxicities, and laboratory test results. During the study, patients will be closely monitored for adverse events, changes in laboratory values, vital signs, and heart function using electrocardiograms ECG. Researchers will also assess pharmacokinetic measures such as drug concentration in the blood over time and the drugs elimination half-life. Cytokine levels will be measured to understand immune responses. Safety follow-up will continue for three months after the last dose. Participation duration and visit schedules will depend on the dosing and monitoring requirements.

This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

Researchers are evaluating the long-term safety and effectiveness of abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. This Phase 3, open-label study will include participants who have previously completed other abrocitinib studies as well as children who have never participated in such studies. The trial aims to better understand how this treatment works over a period of up to 2 years or until the medication becomes commercially available. All participants will receive abrocitinib oral suspension. The study includes two groups an extension cohort of up to 320 children who completed previous abrocitinib studies, and a de novo cohort of approximately 180 children aged 6 to under 12 years who have not received abrocitinib before. The intervention will be given alongside topical medications as needed, and the study will monitor both safety and treatment response during this time. During the study, participants will undergo regular assessments that include monitoring for treatment-emergent adverse events, serious side effects, and reasons for discontinuation. Researchers will also measure clinical responses using tools such as the Investigators Global Assessment, itch rating scales, eczema severity indexes, and quality of life questionnaires. Laboratory tests and vaccination responses will be tracked, and data will be collected throughout the 24-month study period to evaluate long-term effects and safety.

Researchers are evaluating how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is a Phase 3 trial that includes two parts Part A with both children and teenagers, and Part B with only children. Initially, only teenagers who meet the study rules can participate, and children may join once enough information from other studies is available. Participants in Part A will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all participants will receive zasocitinib for the remainder of the study. Participants in Part B will receive zasocitinib throughout the study. Dosages are given orally once daily, with doses adjusted by weight for children aged 4 to under 12 years, and a fixed dose for teenagers aged 12 to under 18 years. The study includes a double-blind placebo-controlled period followed by an open-label period. Participants will be involved for up to 4 years and 2 months, including up to 35 days for screening, 208 weeks of treatment, and a 4-week safety follow-up. During this time, participants will visit the study site multiple times for assessments, including skin evaluations, quality of life questionnaires, and blood tests to monitor drug levels and safety. Researchers will measure how many participants achieve clear or almost clear skin, improvements in psoriasis severity scores, quality of life improvements, and monitor the medicines concentration in the body.