Batumi

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating the treatment of anemia in patients with chronic kidney disease CKD who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 gdL and 12.0 gdL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 21 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods screening up to 28 days, treatment about 52 weeks, and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.

Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.

Researchers are evaluating subcutaneous under the skin durvalumab combined with recombinant human hyaluronidase rHu in adult participants with various solid tumors, including non-small cell lung cancer NSCLC, hepatocellular carcinoma HCC, and limited-stage small cell lung cancer LS-SCLC. The study aims to find a dose of subcutaneous durvalumab that provides similar drug exposure as the intravenous form and to assess its safety and pharmacokinetics in these patients. The study has two parts Part 1 focuses on dose escalation with two planned dose levels of subcutaneous durvalumab plus rHu, followed by intravenous durvalumab at scheduled intervals for participants with NSCLC, LS-SCLC, or unresectable HCC. Part 2 will expand the study to include participants with unresectable HCC using the dose level identified in Part 1. Some participants with unresectable HCC may also receive tremelimumab intravenously. Participants will be monitored over approximately 17 months, with regular assessments of drug levels and safety. The study will measure how much drug is in the body over time and track any adverse events or dose-limiting toxicities. Participants will have evaluations including laboratory tests and clinical assessments to monitor organ function and treatment effects throughout the study duration.

Researchers are evaluating the safety and effectiveness of new drug combinations, including rilvegostomig with standard platinum-based chemotherapy, with or without ramucirumab, for treating advanced or metastatic non-small cell lung cancer NSCLC. This study is open-label and multicenter, involving participants with confirmed stage IV NSCLC. It includes a sub-study with safety run-in and expansion parts to find the best dose and assess treatment activity. Participants receive treatments infused intravenously, including rilvegostomig, ramucirumab, and chemotherapy drugs like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Non-squamous NSCLC participants are randomly assigned to either rilvegostomig plus chemotherapy with ramucirumab or rilvegostomig plus chemotherapy alone, while squamous NSCLC participants receive rilvegostomig plus chemotherapy and ramucirumab. The study includes initial safety evaluation and dose expansion phases. During the study, participants undergo tumor tissue collection, disease measurements, and regular assessments of side effects, tumor response, and survival. Researchers monitor blood samples for drug levels and antibodies and track progression and overall survival over approximately 46 months. Safety, tolerability, and anti-tumor effects are closely followed throughout the treatment and observation periods.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Researchers are investigating the combination of BI-1206, a monoclonal antibody targeting CD32b, with pembrolizumab in adults with advanced solid tumors. This Phase 12a trial aims to determine the appropriate dosing and evaluate the safety of these treatments given together. The study includes patients with advanced solid tumors like uveal melanoma and non-small cell lung cancer NSCLC, assessing disease response and tolerability. Participants receive BI-1206 either intravenously IV or subcutaneously SC every three weeks, along with a fixed 200 mg IV dose of pembrolizumab every three weeks. The trial has two main parts Phase 1 dose escalation to find the recommended doses for IV and SC administration, and Phase 2a where patients with uveal melanoma and NSCLC receive the combination at the selected SC dose. Those showing clinical benefit after three treatment cycles may continue therapy every three weeks for up to two years or until disease progression. During the study, participants will undergo evaluations to monitor side effects, lab tests, and physical exams to assess treatment safety. Researchers will also measure drug levels, immune responses, and receptor occupancy over up to two years. Tumor biopsies and imaging will be performed to evaluate disease status. The study involves regular visits aligned with treatment cycles and includes long-term follow-up for monitoring adverse events and treatment effects.

Researchers are evaluating the effectiveness and safety of combining calderasib with pembrolizumab as the first treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. The study compares this combination to pembrolizumab with a placebo to see if it improves the time participants live without the cancer worsening and overall survival. Participants receive pembrolizumab through an intravenous infusion every 21 days for up to 35 cycles. They also take calderasib or a matching placebo by mouth daily until they meet criteria to stop treatment. The study is randomized and double-blind, meaning neither participants nor researchers know who receives calderasib or placebo. During the study, participants will have regular assessments to monitor cancer progression, overall survival, response rate, and quality of life measures through questionnaires. Safety will be closely monitored by tracking adverse events and treatment discontinuations. The study may last up to about 56 months, including follow-up to observe long-term outcomes and quality of life changes.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.