Wuppertal

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the retention rates of two treatments, Upadacitinib (UPA) and tumor necrosis factor inhibitors (TNFi), in adults with moderate to severe active rheumatoid arthritis (RA). The study is observational, conducted in Germany, and aims to compare how long patients stay on each treatment under real-world conditions according to local labels and standard care. About 678 participants will be enrolled across approximately 80 sites in Germany. Participants will have been prescribed UPA or TNFi independently of the study, following approved labels and local regulations. The study will observe participants receiving either UPA or TNFi therapy over a period of up to 24 months. Participants will be followed for up to 24 months to assess treatment retention. Researchers will monitor how long participants remain on their prescribed treatment and collect related clinical data. The total study duration, including recruitment and follow-up, is expected to last about 48 months.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are assessing the effectiveness of avapritinib (BLU-285) in managing indolent systemic mastocytosis (ISM) among patients in Germany. This non-interventional study aims to fill gaps in understanding the natural history and treatment outcomes of ISM, particularly in participants whose symptoms are not adequately controlled with current symptomatic treatments. The study observes participants in real-world clinical settings without altering their standard care. Avapritinib is given as an oral tablet, and treatment decisions are made by healthcare providers as part of routine care for those with moderate to severe ISM symptoms. Participants start avapritinib treatment at the provider's discretion, following approved prescribing guidelines. No other interventions are assigned by the study, emphasizing observation of usual care in a real-world environment. Participants are followed for up to 24 months, during which researchers monitor changes in quality of life related to mastocytosis using the Mastocytosis Control-quality of Life (MC-QoL) Questionnaire, assessed at the start and at 6 months. The study also collects data on symptom control and safety, focusing on participants who have not previously used avapritinib. This long-term observation helps understand treatment effectiveness and patient experiences over time.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the efficacy, pharmacokinetics, and safety of the drug Mirikizumab in pediatric participants aged 2 to less than 18 years who have moderately to severely active ulcerative colitis (UC). The study focuses on children who have UC lasting at least 3 months and who have not responded to treatments such as corticosteroids, biologics, immunomodulators, or JAK-Inhibitors. This is a multicenter, open-label phase 3 trial aiming to better understand how Mirikizumab works and its safety in this young population. Participants will receive Mirikizumab either intravenously (IV) or subcutaneously (SC) as part of the treatment. The study includes initial treatment and allows participants who complete the trial to enter a long-term extension study called AMAZ. This helps to further assess the drug’s effects over an extended period. The intervention involves monitoring responses after treatment, especially focusing on clinical remission by week 52 among those who responded by week 12. Throughout the study, participants will undergo various assessments to monitor their ulcerative colitis symptoms and overall health. Researchers will measure clinical remission using the modified Mayo score at week 52. Safety and drug levels in the body will also be evaluated. The study involves regular visits and monitoring to track how participants respond to Mirikizumab during the treatment and follow-up periods, providing comprehensive data on the drug’s impact in pediatric UC patients.

Researchers are evaluating the safety and effectiveness of NT 201, a botulinum toxin drug, compared with a placebo in adults who have moderate to severe platysma prominence, which involves prominent neck bands. This Phase 3 study is conducted in Europe and focuses on improving the appearance of these neck muscles. The study aims to see how well NT 201 works and how safe it is for participants with this condition. Participants will receive either NT 201 or a matching placebo injection, which contains Clostridium Botulinum neurotoxin A without complexing proteins. The study has two parts: the Main Period (MP), where the initial treatment is given and evaluated, and an Open Label Extension Period (OLEX) that follows. The effectiveness is primarily measured by improvement on the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) at two weeks after treatment. During the study, participants will be assessed by both investigators and themselves for platysma band severity and improvement. Safety and treatment outcomes will be monitored throughout the study periods. The total involvement includes screening, treatment, and follow-up assessments to observe the drug's impact and any side effects over time.

Researchers are evaluating the dosimetry, safety, and tolerability of up to 12 cycles of the drug lutetium (177Lu) vipivotide tetraxetan (also called AAA617) in adult men with metastatic castration-resistant prostate cancer (mCRPC) who have PSMA-positive tumors and have progressed after prior androgen receptor pathway inhibitor treatment. This phase 1 study focuses on participants with normal or mildly impaired kidney function and who have not previously received taxane chemotherapy. The goal is to better understand how the drug distributes in the body and how well patients tolerate the treatment. Participants will receive intravenous infusions of AAA617 at a dose of 7.4 GBq every 6 weeks for up to 12 cycles, unless disease progression, toxicity, or other factors require stopping treatment sooner. After the initial 6 cycles, participants will have a PSMA-PET scan to reassess tumor expression and eligibility for further treatment. The treatment period can last up to 74 weeks. Other drugs such as gonadotropin-releasing hormone analogues or antagonists may also be given as part of standard care. Throughout the study, participants will undergo multiple PSMA-PET scans including at baseline, after 6 cycles, and at the end of treatment. Researchers will monitor radiation dose to organs, track adverse events and serious adverse events, and record any dose adjustments. Follow-up includes safety checks up to 42 days after the last dose, survival monitoring, and assessments of disease progression. The study involves screening, treatment, and post-treatment follow-up phases to comprehensively assess effects and safety over time.