A Phase 2a Multicenter Randomized Doubleblind Study Evaluating the Efficacy and Safety of Subcutaneously Administered combination therapy in Improving the Signs and Symptoms in Participants with Active Psoriatic Arthritis.
This is a Phase 2a randomized, double-blind, active-controlled, parallel-group, multicenter,proof-of-concept (POC) clinical study designed to evaluate the efficacy and safety of combination therapy with guselkumab+golimumab (guselkumab 100 mg q4w + golimumab 50 mg q4w) versus guselkumab monotherapy (guselkumab 100 mg q4w + placebo) in adults with active PsA who have a previous history of IR to one anti-TNFa therapy either due to primary nonresponse or loss of efficacy.
A Phase 2a Study with Safety Run-in to Evaluate the Safety Tolerability and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors
This is a medical study testing a drug called FF-10832 alone and with another medicine called pembrolizumab for patients with advanced solid tumors. First, patients will try both drugs together to make sure there minimum side effects. The study team will use FF-10832 at a certain dose with a fixed amount of pembrolizumab. If there are minimum to no side effects, the study team might try a lower dose for more patients. They'll keep checking and might use even smaller doses if needed and approved. Then, the study team will bring in more patients with two types of cancer: one in the bladder (urothelial cancer) and another in the lungs (non-small cell lung cancer). Each group of patients will be split into four smaller groups. These patients' cancers got worse after PD-1/PD-L1 therapy. Some patients will get just one drug, while others will get both, to see how safe and helpful FF-10832 is alone or with pembrolizumab. The study team might also include more types of cancer based on the first safety check.
A Phase 2b Double-Blind Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis
This study includes a. screening period. 12-week double-blind, placebo-controlled treatment period. 48-week double-blind treatment period, and. post-treatment follow-up.At Week 12, participants receiving placebo Q4W will begin receiving either 400 mg or 1000 mg peresolimab Q4W. Treatment assignment will be blinded and the participants will continue their assigned peresolimab dose and dosing frequency until the end of the study.Participants randomly assigned to 100 mg peresolimabParticipants receiving 100 mg peresolimab will continue their assigned dose and dosing frequency throughout the duration of the treatment period. No changes will occur.Participants randomly assigned to 400 mg or 1000 mg peresolimabParticipants receiving 400 mg or 1000 mg peresolimab will continue their assigned dose and dosing frequency until Week 24. At Week 24, participants may be switched to Q12W dosing following assessment of CDAI scores, unless they received rescue medication prior to Week 24.
A Phase 2b Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes
The purpose of this study is to investigate the safety of the investigational drug (LY3437943) in the kidney, and how well it works to help participants obesity or overweight with chronic kidney disease. The main reason for you to take part in this study is not to treat you for your condition but to help in answering the following research questions: How LY3437943 compares to placebo in helping people with obesity or overweight and chronickidney disease with or without Type 2 Diabetes Mellitus (T2DM). The safety of LY3437943 and any side affects you might have when you take it.
A Phase 2b Randomized Controlled Double-blind Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis
This is a Phase 2b, randomized, double-blind, placebo-controlled, global, multicenter study to evaluate efficacy and safety of zetomipzomib in patients with active Class III/IV +/-V LN or pure Class V. The study will enroll approximately 279 patients: 249 patients with biopsy-proven Class III/IV +/-V LN with urine protein to creatinine ratio (UPCR) =1.0 and up to 30 patients with pure Class V with UPCR =2.0. Zetomipzomib will be administered at a dose level of 30 mg or 60 mg (the latter following step-up from an initial Week 1 dose of 30 mg). For each dose group, patients will be randomized in a 2:1 ratio to receive either zetomipzomib or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up visit. Each treatment group (30 mg, 60 mg, or placebo) will include approximately 83 patients per group with Class III/IV +/-V and up to 10 per treatment group with pure Class V LN, for a total of up to 279 patients. During the treatment period, patients will also receive background standard of care therapy consisting of MMF or equivalent for 52 weeks plus corticosteroids tapered over 16 weeks.
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 2b Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-2)
This study is a randomized, double-blind, placebo-controlled, multicenter, Phase 2b study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 (as capsule, P.O.) versus placebo in study participants with moderately to severely active UC. The study will have 4 treatment groups: (1) MORF-057 (xxx mg B.I.D., P.O.), (2) MORF-057 (xxx mg B.I.D., P.O.), (3) MORF-057 (xxx mg Q.D., P.O.), and (4) matching placebo (B.I.D, P.O.). Approximately 280 participants will be randomized into the treatment groups in a 1:1:1:1 ratio (i.e, 70 participants per group). For each treatment group, at least 40% of the participants will be advanced therapy-naïve (i.e., have no previous exposure to an advanced therapy treatment for UC) and at least 40% will be advanced therapy-experienced (excluding vedolizumab). Randomization stratification factors will include baseline MES (
A Phase 3 Double-blind Placebo-controlled Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy with DBV712 250 g in 4-7-year-old Children with Peanut Allergy
This is a 12-month, Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of daily DBV712 250 µg in peanut-allergic children aged 4-7 years.The overall maximum study duration for each subject is approximately 58 weeks: 4-week Screening Period, 12-month Treatment Period and 2-week Follow-up Period.
A PHASE 3 MULTI-CENTER MULTI-NATIONAL RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS
CC-93538 is a recombinant humanized, high-affinity neutralizing (immunoglobulin G1 kappa [IgG1?]) monoclonal antibody (mAb) selective for interleukin-13 (IL-13). CC-93538 binds to IL-13, thus preventing its interaction with both IL-13 receptors, IL-13 receptor alpha 1 (IL-13Ra1) and IL-13 receptor alpha 2 (IL-13Ra2). Eosinophilic esophagitis (EoE) is a chronic immune/antigen-mediated esophageal disease characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation, and IL-13 has been shown to be a key driver of disease pathology in patients with EoE.The Phase 3 program includes a multi-center, multi-national, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with EoE (Study CC-93538-EE-001) with a separate, optional Open-Label Extension Study (OLE; Study CC-93538-EE-002).Results of the Phase 2 Study, RPC02-201, in adult subjects with EoE showed that administration of CC-93538 180 mg and 360 mg subcutaneously (SC) weekly for 16 weeks reduced the mean esophageal eosinophil count (the primary endpoint) and improved other inflammatory parameters. A greater reduction in dysphagia symptoms was observed with the 360 mg dose although it did not reach statistical significance. The study also demonstrated the safety and tolerability of CC-93538 in adult subjects with symptomatic EoE treated with one of two dose levels (CC-93538 180 mg or 360 mg SC) compared to placebo. CC-93538 was generally safe and well-tolerated for up to 68 weeks of treatment (including data from a 52-week CC-93538 Open-Label Extension). These data support the continued development of CC-93538 as a novel treatment for EoE. The single pivotal Phase 3 study is designed to confirm and extend the findings obtained from the positive Phase 2 study with CC-93538.
A PHASE 3 MULTI-CENTER RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NON-OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial in participants with symptomatic nHCM. Approximately 420 eligible participants will be randomized in a 1:1 ratio to aficamten or placebo. Doses of 5, 10, 15, or 20 mg aficamten or matching placebo will be administered in an escalating manner using echocardiography to guide dose titration. Randomization will be stratified by persistent atrial fibrillation and presence of intracavitary obstruction.This Phase 3 trial of aficamten in participants with nHCM is designed to further evaluate the effect of aficamten on quality of life, exercise capacity, heart failure symptoms, cardiac biomarkers, cardiac remodeling, and clinical outcomes. Additionally, the safety and tolerability of aficamten will be assessed in participants with nHCM.This multinational trial will be conducted at approximately 150 investigational sites.Approximately 420 participants will be randomized across all sites.