A Phase 2b / 3 Multicenter Randomized Double-blind Placebo-controlled Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis
The purpose of this research study is to see if CSL300 (Clazakizumab) is effective and safe in patients on maintenance dialysis at reducing the risk of dying from heart-related events or having a heart attack.
A Phase 2b Randomized Double-blind Placebo-controlled Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat psychiatric (anxiety, depression) and existential distress (demoralization, death anxiety), and quality-of-life (QOL), in 200 outpatients with late-stage or advanced cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg oral ‘high’ dose of psilocybin to a single 100mg dose of niacin (active placebo), both delivered in conjunction with a psychotherapy platform.
A Phase 3 Double-Blind Placebo-Controlled Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with DBV712 250 g in 1-through 3-year-old Children with Peanut Allergy
The purpose of this study is to learn how well an investigational drug patch (DBV712) works and how safe it is compared with a placebo patch in 1 to 3-years-old children with a peanut allergy. DBV712 contains a small amount of peanut protein and is designed to potentially desensitize (or make less sensitive) a peanut-allergic person by repeated exposures to very small amounts of peanut via the skin. The objective of the study drug patch would be to prevent and/or minimize the severity of allergic reactions if a peanut-allergic person is accidentally exposed to peanuts. This study will last about 34 weeks. You and your child will be asked to attend at least 8 in-person visits and 5 phone calls.
A Phase 3 Double-blind Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2- negative Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive.
This is a Phase 3 study testing whether the study medicine zolbetuximab (monoclonal antibody), together with pembrolizumab (PD-L1 inhibitors ) and chemotherapy (CAPOX or mFOLFOX6), works more effectively with fewer potential side effects as compared to placebo, pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) as first treatment for patients with gastric cancer whose tumors show changes in HER2, CLDN18.2, and PD-L1 genes. Patients will be randomly divided into two groups. Group A patients will receive zolbetuximab in combination with pembrolizumab and chemotherapy (CAPOX or mFOLFOX6). Group B patients will receive a placebo in combination with pembrolizumab and chemotherapy (CAPOX or mFOLFOX6).
A Phase 3 Multi-center Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
To evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH compared with placebo as measured by the OHSA composite score over a double-blind, RW period of 8 weeks following an OL period of 12 weeks.This study includes 4 periods: Screening, OL, RW, and Long-Term Treatment Extension (LTE). Screening is approximately 14 days. The OL and RW periods of the study are a Phase 3, multi-center, RW study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. Approximately 102 participants will be enrolled such that at least 72 participants continue into the RW period. The LTE period is to evaluate the safety and tolerability of ampreloxetine in participants with MSA and symptomatic nOH over 104 weeks.
A Phase 3 Multicenter Randomized Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE FL-2)
This is a Phase 3 study testing whether the study medicine epcoritamab (an IgG1-bispecific antibody) in combination with other medicines called Rituximab (monoclonal antibody) and Lenalidomide (immunomodulant drug) can work better compared to standard chemotherapy medicines in patients with Follicular Lymphoma (FL) who have not received any previous treatment. Patients will be divided into four treatment groups. Patients in the first group will receive Epcoritamab in combination with rituximab and lenalidomide. These patients will continue to receive Epcoritamab medicine as a maintenance treatment, meaning a therapy to delay the recurrence of cancer. Patients in the second group will receive Epcoritamab together with rituximab and lenalidomide. Patients in the third group will receive Chemotherapy medicine chosen by the study doctor, and patients in the fourth group will receive lenalidomide + rituximab. All patients will have special scans taken to see how these medicines are changing their tumor size and helping them stay cancer-free for a longer time compared to standard chemotherapy medicines. The study team will take patients’ blood samples to see how their bodies handle the medicines. Patient’s tumor samples will be taken to learn more about how the medicine works on the tumor. The study team will closely watch all patients for side effects and followed up after treatment.
A phasE 3 open-label multiceNter randomized crossover trial comparing tHe safety and efficAcy of ASI-02 to agitated saline for suspEcted right-to-left shunt (ENHANCE Study)
The purpose of this research study is to assess the safety and effectiveness of a study drug-device combination product known as ASI-02. The researchers want to learn how the product works when it is used in people with suspected right-to-left shunt undergoing transthoracic echocardiography (TTE).
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant HR+ HER2- Locally Advanced or Metastatic Breast Cancer
This is a Phase 3 study testing whether the study medicine RLY-2608 (selective inhibitors of PI3Ka) along with fulvestrant (standard hormone therapy) is more effective and safer than other medicines, such as capivasertib (AKT inhibitor) and fulvestrant combination for patients with HR+/HER2- advanced breast cancer, whose cancer has come back after prior treatment with a CDK4/6 inhibitor and shows changes in the PIK3CA gene. Patients will be randomly divided into two groups. Group 1 will receive the RLY-2608 and fulvestrant, and Group 2 will receive capivasertib and fulvestrant. The study team will monitor all patients for the time interval it takes for the cancer to come back or worsen (PFS) for both groups, as well as the overall survival of patients. Blood samples will be collected from all patients to see how their bodies are handling the study medicine and to check their overall well-being. Specialized testing known as ctDNA testing will be done for all patients to learn about their cancer. All patients will undergo special scans to check how their tumors are responding to the medication. All patients will be closely monitored for potential side effects and safety concerns.
A Phase 3 Randomized Active-controlled Open-label Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)
This is a Phase 3 study testing whether the study medicine MK-2870 is safer and more effective compared to the doctor's choice of other standard chemotherapy medication in patients with cervical cancer that has spread from the primary site (metastatic) or has come back after previous treatment (recurrent). MK-2870 is an antibody-drug conjugate that attacks and kills cancer cells more specifically than traditional chemotherapy. The study will be done in two parts. In Part 1, called Run-in, a small number of patients will be enrolled to test whether MK-2870 at a dose of 4 mg/kg is safe and effective in patients with metastatic cervical cancer. In Part 2, called Phase 3, a larger number of patients will be randomly divided into two groups. Group 1 will receive the study medication, MK-2870, at 4 mg/kg. Group 2 will receive the doctor’s chosen treatment, which will be one of the following: Pemetrexed, Tisotumab vedotin, Topotecan, Vinorelbine, Gemcitabine, or Irinotecan. All patients will have regular study visits throughout the study duration. Blood samples will be collected to check how patients are doing and learn how their bodies are handling the study medications. Specialized blood testing to monitor changes in DNA, RNA, and proteins (biomarkers) and ctDNA (circulating tumor DNA, which are small pieces of DNA shed by tumor cells in the blood) will be done to learn more about patients’ cancer and further help them with treatment. Special scans will be done for all patients to see how their tumors are changing in response to the study medication. All patients will be closely monitored for potential side effects and safety concerns.
A Phase 3 Randomized Double-Blind Dose-Ranging Evaluation of Transcutaneous Vagus Nerve Stimulation (tVNS) to Reduce Temper Outbursts in People with Prader-Willi Syndrome (PWS)
The purpose of this trial are to determine the acceptability, safety,and effectiveness of Transcutaneous Vagus Nerve Stimulation (tVNS) to treat the severe behavior problems, specifically, temper outbursts, that affect people with Prader-Willi syndrome (PWS).