Dearborn

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatment's effects and safety.

Researchers are evaluating the safety and tolerability of DB-1303/BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 1/2a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts: an initial dose-escalation phase using an accelerated titration followed by a classic "3+3" design to find the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303/BNT323 by intravenous infusion once every three weeks (Q3W) at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are evaluating the safety, tolerability, and effect on albuminuria of the drug MZE829 in adults with proteinuric chronic kidney disease who carry the APOL1 high risk genotype. This open-label Phase 2 study focuses on participants with proteinuria and the specific genetic risk factors G1/G1, G2/G2, or G1/G2. The study aims to better understand how MZE829 impacts kidney disease in this targeted group. Participants will receive MZE829 capsules taken orally. The study includes two groups: one with chronic kidney disease and concurrent diabetes, and another with chronic kidney disease without diabetes. The treatment period lasts 12 weeks, during which safety and tolerability will be closely monitored along with the drug's effect on albuminuria. This design allows researchers to assess the drug’s impact across different patient profiles. During the study, participants will be monitored from Day 1 through Week 12 with regular assessments for adverse events and measurement of albuminuria reduction. Researchers will also track plasma drug concentrations to understand how the body processes MZE829. Safety and tolerability will be evaluated based on the incidence of any adverse events throughout the 12-week treatment period. The total duration involves close observation and follow-up during this timeframe to evaluate the study outcomes.

Researchers are evaluating the efficacy and safety of brenipatide compared to a placebo for helping adults who have recently quit smoking avoid relapse. This phase 2, multicenter, randomized, double-blind study focuses on reducing the risk of returning to cigarette smoking. The study is sponsored by Eli Lilly and Company and involves participants aged 18 to 75 years who are motivated to stay quit from smoking. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injections. The study includes a 2-week screening period, followed by a 24-week treatment period where participants self-inject the study drug or placebo. After treatment, there is an 8-week safety follow-up to monitor participants. The study involves up to 17 visits during the 34 weeks of participation. During the study, researchers will measure the percentage of participants who maintain continuous abstinence from smoking confirmed by carbon monoxide testing from week 1 to week 24, allowing for slips. Additional assessments include patient-reported outcomes, changes in body weight, pharmacokinetic measurements of brenipatide, and detection of anti-drug antibodies. Participants need to be reliable in attending visits and following study procedures, including self-injection. Safety monitoring continues throughout the follow-up period.

Researchers are evaluating IBI363, a study drug, in adults with advanced solid cancers that have not responded to previous treatments. This Phase 2, open-label, multicenter trial aims to assess the drug's effectiveness, safety, and tolerability in people with melanoma, non-small cell lung cancer, colorectal cancer, and renal cell cancer. Participants will receive IBI363 as an intravenous infusion every two or three weeks. They will continue treatment until their disease worsens, they experience intolerable side effects, they choose to stop, the treatment duration reaches 24 months, or other reasons require stopping. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatment. During the study, participants will undergo regular assessments including monitoring of tumor response for up to two years and safety evaluations for adverse events up to 90 days after the last dose. Dose-limiting toxicities will be observed during specific time frames depending on the dosage schedule. Participants' overall health and disease status will be closely followed throughout the trial period, which starts in April 2024 and ends in December 2026.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 2/3, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone (TSH) levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in patients aged 1 to under 31 years with first relapse of CD19+ B-cell acute lymphoblastic leukemia (B-ALL), including those with Down syndrome. This phase II trial aims to compare event-free survival and remission rates, as well as assess safety and tolerability of these treatments in this patient group. Treatment involves several groups and arms with different combinations of drugs including dexamethasone, blinatumomab, nivolumab, methotrexate, and others. Some groups receive pre-immunotherapy treatments depending on disease characteristics. Treatment cycles last about 36 to 37 days and may repeat up to two cycles unless disease progression or unacceptable toxicity occurs. Radiation therapy and various chemotherapy regimens are also part of the treatment for certain patients. Participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collections of blood, urine, and cerebrospinal fluid throughout the study. After treatment completion, they are followed up every 3 months for 1 year. The main results measured include minimal residual disease-negative remission rates and event-free survival. Safety, adverse events, and other clinical factors are closely monitored during and after treatment.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage (stage I and II) classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments: some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease (COPD) to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.