Buxtehude

Researchers are evaluating the activity and safety of barzolvolimab compared to placebo in adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. This Phase 3, randomized, double-blind, placebo-controlled trial aims to understand how barzolvolimab works in these conditions that cause hives and itching triggered by cold or skin friction. Participants will first go through a screening period of up to 4 weeks to confirm eligibility. The treatment period lasts 52 weeks and has two parts for the first 24 weeks, patients receive either barzolvolimab or placebo by subcutaneous injection every 4 weeks, with an initial barzolvolimab dose of 450mg followed by 150mg doses. For the next 28 weeks, all patients receive 300mg barzolvolimab every 8 weeks. After treatment, there is a 16-week follow-up period during which participants are observed without receiving study drug. During the study, participants will have provocation testing to measure responses at various time points, including weeks 4, 12, and 24. Researchers will assess symptoms like itch and hives and measure thresholds related to cold and friction triggers. Participants will complete daily symptom diaries and attend regular visits for safety monitoring and assessments. The main outcome is a complete response to provocation testing at week 12. Overall participation lasts about 1 year including screening, treatment, and follow-up.

Researchers are evaluating whether tralokinumab given as subcutaneous injections along with topical corticosteroids TCS is safe and effective for treating moderate-to-severe atopic dermatitis AD in children and infants. The trial involves two age groups children aged 2 to under 12 years and infants aged 6 months to under 2 years. Children are randomized to receive either tralokinumab plus TCS or placebo plus TCS, while infants receive open-label tralokinumab plus TCS. This Phase 3 trial will last up to four years with visits every two weeks during the first year and every six weeks thereafter, including some phone visits.

Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.

Researchers are evaluating the safety, tolerability, and anti-tumor activity of IMA402 in adults with recurrent andor refractory solid tumors. This Phase III trial aims to determine the maximum tolerated doses and recommended doses for IMA402 alone and in combination with pembrolizumab. The study also seeks to characterize safety and anti-tumor effects, along with pharmacokinetics, in patients who have advanced or metastatic solid tumors that are measurable and confirmed by specific tests. The trial has three phases Phase Ia focuses on dose escalation and de-escalation to find safe dosage levels Phase Ib involves dose extension cohorts to further evaluate these doses and Phase II studies selected patient groups to examine safety and anti-tumor activity more closely. Treatments include IMA402 given by intravenous infusions either alone or combined with checkpoint inhibitors, chemotherapy, monoclonal antibodies, or IMA401. Participants receive these infusions according to their assigned group and dose level. Participants will undergo assessments to monitor treatment safety and effectiveness, including evaluations of adverse events, tumor response using standard criteria, and pharmacokinetic measurements over up to 40 months. Researchers will track dose limiting toxicities, treatment-emergent adverse events, and tumor response rates. Safety and tolerability are closely monitored throughout, with visits scheduled regularly to assess health status and treatment effects during the trial period.

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 evaluating the long-term safety of nivolumab alone or in combination with other cancer therapies in patients with various tumor types. This Phase 2 study focuses on monitoring the effects and side effects of these treatments over an extended period to understand their safety profiles better. Participants receive one of several treatment regimens involving drugs such as nivolumab, ipilimumab, cabozantinib, trametinib, relatlimab, and others. Each treatment is given at specified doses on set days, with some regimens combining multiple drugs. The study includes patients who have previously participated in Bristol-Myers Squibb sponsored trials and may continue or restart treatment based on prior response. Throughout the study, participants undergo regular safety assessments to track adverse events, including serious, immune-mediated, and drug-related side effects. Monitoring continues from the first day of treatment up to 135 days after stopping treatment to assess the incidence of adverse events and deaths. This comprehensive safety monitoring helps researchers understand the long-term effects of these cancer therapies over several years.

Researchers are studying bee venom allergy and the effectiveness of venom immunotherapy VIT, which is known to provide long-term protection from severe allergic reactions to insect stings. The study focuses on understanding why VIT is less effective for bee venom compared to vespid venom. They are particularly investigating whether sensitization to specific bee venom components, especially Api m 10, increases the risk of treatment failure. Participants will receive bee venom immunotherapy following protocols they can select. Before starting treatment, blood samples will be taken to measure specific IgE levels to bee venom components. After reaching maintenance doses, patients will undergo sting challenges to assess the treatment outcome and identify risk factors for failure related to sensitization and other factors like antibody levels and medication use. During the study, researchers will monitor participants through blood tests and controlled sting challenges, observing immune responses and any side effects. The primary outcome is to determine if predominant sensitization to Api m 10 predicts treatment failure within about six months after maintenance dose. Secondary outcomes include assessing other venom components, antibody levels, systemic side effects, and medication impact, with the total observation period depending on the timing of the sting challenge.

Researchers are conducting a prospective, non-interventional observational study to understand how patients aged 6 years and older with atopic dermatitis AD respond to treatment with dupilumab in everyday medical practice. The study aims to characterize these patients by examining their medical history, demographic and disease-related features, associated allergic conditions, other type 2 inflammation diseases, and their past and current treatments. The study will also assess the long-term effectiveness and safety of dupilumab over two years, focusing on disease control and quality of life.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.