Naperville

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

This research aims to evaluate the safety and effectiveness of NT 201 compared with a placebo in adults who have moderate to severe platysma prominence, which involves noticeable bands in the neck muscles. The study is a Phase 3 clinical trial conducted in the United States, focusing on assessing the impact of this treatment on these muscle bands using a specific rating scale. Participants will receive either NT 201, a botulinum toxin type A injection, or a placebo during the Main Period (MP) of the study. After this, there is an Open Label Extension Period (OLEX) where participants may continue to be observed or treated. The NT 201 is provided as a powder that is prepared for injection, and the study is designed as a randomized, double-blind, parallel-group trial across multiple centers. During the study, participants will be closely monitored with assessments that include both the investigator's and participant's ratings of platysma prominence using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D). The primary outcome is measured at Week 2 of the Main Period by evaluating the improvement in platysma appearance. Safety and efficacy will be carefully tracked throughout the study periods to ensure participant well-being and to gather comprehensive data on treatment effects.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.