A Phase 2/3 randomized double-blind placebo controlled parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)
The purpose of this research study is to test if belimumab is well-tolerated, works well and helps treat interstitial lung disease and other aspects of disease associated with systemic sclerosis such as skin thickening.
A Phase 2a Multicenter Randomized Double-Blind Placebo- Controlled Study of the Safety and Efficacy of TB006 in Participants with Parkinson s Disease
The purpose of this study is to see if the study drug improves motor function in Parkinson's disease (PD) patients.
A Phase 2a Multicenter Randomized Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate the safety and efficacy of using multiple investigational medicines compared to a single medicine in subjects with moderate to severe Crohn’s Disease. The medicines being used in this study are Risankizumab, ABBV-382, and Lutikizumab.
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 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 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).
A Phase 3 Randomized Double-blind Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with Resected Stage II IIIA IIIB (N2) Non-small Cell Lung Cancer
This clinical study will evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II to IIIB (N2) NSCLC.