Lansing

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to the standard chemotherapy treatments in patients with locally advanced or metastatic urothelial cancer. This Phase III trial focuses on cancers that have spread to nearby tissues, lymph nodes, or other parts of the body. The study aims to compare overall survival and other outcomes such as progression-free survival, response rates, clinical benefits, duration of response, and treatment toxicity between the two treatment approaches. Quality of life and fatigue are also assessed as secondary measures. Participants are randomly assigned to one of two treatment groups. One group receives standard of care chemotherapy, which may include carboplatin or cisplatin combined with gemcitabine, or alternatively docetaxel or paclitaxel, administered intravenously in cycles every 21 days for up to six cycles, unless the disease progresses or side effects become unacceptable. The other group receives sacituzumab govitecan-hziy intravenously on days 1 and 8, along with pembrolizumab intravenously on day 1 of each 21-day cycle, continuing for up to 35 cycles or two years, unless there is disease progression or unacceptable toxicity. Throughout the study, participants undergo regular blood sample collections and imaging scans using computed tomography or magnetic resonance imaging to monitor their condition. Quality of life questionnaires are also completed to assess symptoms and fatigue over time. After treatment ends, patients are followed up 30 days later and then annually for up to five years to evaluate long-term outcomes and safety. The main outcome measured is overall survival from the time of randomization up to five years.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

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 drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating the safety and tolerance of elritercept, a recombinant fusion protein, in adults with anemia linked to lower-risk myelodysplastic syndromes (MDS). The study aims to understand how elritercept affects red blood cell production and to monitor participants for any worsening of MDS during treatment. This is a Phase 2, open-label study focused on patients with very low, low, or intermediate risk MDS. Participants receive elritercept through subcutaneous injections at different dose levels to assess safety and effects. The study includes multiple parts, with initial treatment cycles followed by an extension phase for those who complete the first part without dose-limiting toxicities and may benefit from continued treatment. The study also includes several cohorts based on specific MDS characteristics and transfusion needs. During the study, participants undergo regular evaluations including blood tests, bone marrow assessments, and monitoring for adverse events. Researchers will track the number of treatment-emergent and serious adverse events for up to 11.2 years. Participants are closely monitored for how well they tolerate elritercept and its impact on anemia and red blood cell production throughout the study duration.

Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by the build-up of immune protein complexes in the kidneys, leading to inflammation and possible kidney damage. This Phase 3 study is evaluating how well mezagitamab, compared to a placebo, reduces protein levels in the urine (proteinuria) in adults with primary IgAN. It also aims to assess the safety and tolerability of mezagitamab and its ability to maintain kidney function over the long term. Participants will be randomly assigned to one of two groups in the main study: two-thirds will receive mezagitamab injections under the skin, and one-third will receive placebo injections that look identical but have no active medicine. Treatment will occur in two 1-year cycles, each including about six months of dosing and six months of observation with monthly check-ups. An open-label group will include a small number of participants with lower proteinuria or kidney filtering issues, including those who previously received mezagitamab in another study; these participants will receive mezagitamab similarly to the main group. During the study, participants will visit the clinic several times for assessments. Researchers will monitor changes in proteinuria from the start through week 36, along with safety and kidney function. They will also perform regular evaluations and check-ups throughout each treatment and observation period to track participants' health and response to treatment.

Researchers are evaluating the safety and effectiveness of obexelimab in adults with systemic lupus erythematosus (SLE). Participants must have had an SLE diagnosis for at least 24 weeks and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria. Eligible patients must have active SLE with specific disease activity scores and be receiving certain standard lupus treatments such as oral corticosteroids, antimalarials, or immunosuppressants. The study includes a 24-week treatment period where participants are randomly assigned to receive either obexelimab or a placebo through weekly subcutaneous injections. Before treatment, there is a screening period lasting up to 28 days, and after the treatment phase, participants enter a 12-week follow-up period. Visits to the study site occur at weeks 2, 4, and then every 4 weeks throughout the study. During the study, participants will undergo regular assessments to monitor treatment effectiveness, safety, drug levels, immune response, and overall health. The maximum time a participant can be involved in the study, including screening and follow-up, is about 40 weeks. Researchers will collect data to evaluate how well obexelimab works and its safety profile in managing SLE symptoms.

Researchers are evaluating if adding a special device called the TheraBionic P1, which uses amplitude-modulated radiofrequency electromagnetic fields, can impact the treatment response in women with early-stage, operable breast cancer that is hormone receptor positive and HER2-negative. This pilot study focuses on patients scheduled for surgery and aims to understand how this device affects the cancer before removal. Participants will use the TheraBionic P1 device by self-administering three 60-minute treatments each day—morning, midday, and evening—continuously for about two weeks before their planned surgery to remove the tumor. The device delivers specific electromagnetic fields targeting the cancer during this pre-surgical period. During the study, participants will be closely monitored, and their pathological response to the treatment will be assessed at the time of surgery, approximately two weeks after starting the device therapy. Researchers will review tissue samples and track safety measures while ensuring participants follow the treatment and study protocols. This involvement lasts from treatment initiation through surgery and includes follow-up monitoring for adherence and safety.

Researchers are evaluating the overall survival of males with chemotherapy-naefve metastatic castration-resistant prostate cancer (mCRPC). This phase 3 randomized study compares treatment with xaluritamig plus abiraterone to the investigator's choice of docetaxel, cabazitaxel, or abiraterone. Participants must have confirmed prostate adenocarcinoma with metastatic lesions and evidence of disease progression despite prior androgen receptor pathway inhibitor therapy. The study includes two treatment groups: one receiving intravenous xaluritamig combined with oral abiraterone acetate, and the other receiving the investigator's choice of chemotherapy drugs docetaxel or cabazitaxel administered intravenously, or abiraterone taken orally. Participants intended for cabazitaxel must have had up to six cycles of prior docetaxel in the metastatic hormone-sensitive setting. Treatments are administered per protocol during the randomized phase. Participants will be monitored for overall survival for up to approximately 51 months. Eligibility requires adequate organ function and good performance status. The study excludes those with prior chemotherapy in the mCRPC setting, certain prior therapies, unresolved toxicities, or CNS metastases. Researchers will assess survival outcomes along with safety and treatment tolerability throughout the study duration.