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.
A Phase 3 Randomized Double-Blind Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis
This trial is testing MK-7240 in people with moderate to severely active ulcerative colitis (UC). This trial will compare MK-7240 to placebo. A placebo looks like a trial drug, but it has no active ingredients. The purpose of this trial is to: Test the safety of the trial drug, MK-7240 See how well the trial drug works compared to placebo
A Phase 3 Randomized Double-Blind Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn s Disease
This trial is testing an experimental drug tulisokibart (MK-7240) in people with moderately to severely active Crohn’s disease (CD). This trial will compare tulisokibart to placebo. A placebo looks like a trial drug, but it has no active ingredients. The purpose of this trial is to test the safety of the trial drug, tulisokibart, and see how well tulisokibart works, compared to placebo, The trial drug you get will depend on which group you are placed in. Study 1 has 4 groups: Groups 1, 2, and 3 will get different doses of tulisokibart. Group 4 will get placebo only.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
The purpose of this study is to evaluate the safety and efficacy (how well something works) of EFX in people with NASH/MASH. NASH/MASH is part of a group of conditions called non-alcoholic fatty liver disease (NAFLD)/metabolic dysfunction-associated steatotic liver disease (MASLD). EFX is an investigational drug, meaning it is being tested in this research study and is not Food and Drug Administration (FDA) approved to treat this condition.
A Phase 3 Randomized Double-blind Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome (PWS)
This research study is being done to see if a new drug called ARD-101 can help treat people with hyperphagia due to PWS.
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj gren s Syndrome With Moderate-to-Severe Symptom State
The Oasiz-303 Study is evaluating the safety and effectiveness of an investigational medicine in people living with Sjögren’s. This investigationalmedicine works differently from other medicines for Sjögren’s. While available medicines may help to manage symptoms, this investigational medicine is being evaluated to see if it may have an effect on disease progression. The research study will last up to 60 weeks (14 months) and will require up to 16 visits to the study site. After completing the Study Treatment Period, you may be eligible to join an extension study, during which all participants will receive the investigational medicine for a period of time.
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj gren s Syndrome With Moderate-to-severe Systemic Disease Activity
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a study drug called dazodalibep (also known as VIB4920) in participants with Sjögren's syndrome (SS). Dazodalibep is being developed as a potential treatment for SS, which causes the body’s immune system to attack itself. The immune system helps the body fight off infections. When the body's immune system attacks itself, this can cause what is called an “autoimmune disease”. Dazodalibep is designed to target the immune system cells responsible for these attacks. Dazodalibep is an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sj gren s Syndrome (POETYK-SjS-1)
This is the first time deucravacitinib is being studied in people with Sjogren’s Syndrome. By doing this study, researchers hope to learn more about whether deucravacitinib can help in the treatment of Sjogren’s Syndrome (SjS) and how safe it is to use in participants with active SjS. Deucravacitinib is an experimental drug, which means its safety and effectiveness have not been established and it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of SjS. Placebo for deucravacitinib treatment consists of a pill that looks like the study drug but does not contain any active study drug.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POETYK-SLE-2)
The 52-week double-blinded study is divided into 3 separate periods that will take about 60 weeks to complete:• Screening Period (4 weeks), • Treatment Period (52 weeks), and • Safety Follow-Up (4 weeks). • The Treatment Period is called a “Double-Blinded” or “Blinded” Treatment Period because neither you nor your study team will know whether you are getting deucravacitinib or placebo. There is a 50% chance of being on deucravacitinib and a 50% chance of being on placebo during this 52-week Treatment Period.Participants who complete the Treatment Period (either on deucravacitinib or placebo), may be able to enter into an optional Long-Term Extension (LTE) Period of up to 2 years (104 weeks). -
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POTEYK-SLE-1)
This is a Phase 3, randomized, parallel-arm, double-blind, PBO-controlled, multicenter 52-week clinical trial to evaluate the efficacy and safety of deucravacitinib in adult participants with active SLE while receiving stable background standard of care treatment. There is an optional 104-week open-label long-term-extension (LTE) period.