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PHASE III RANDOMIZED OPEN-LABEL MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE WITH A NON RANDOMIZED SINGLE ARM US EXTENSION OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY
This is a Phase III, open-label, multicenter, randomized controlled trial in patients with R/R FL after receiving at least 1 line of systemic therapy ... -
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Non-Biologic Lupus Standard of Care
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to evaluate the efficacy and safety of BIIB059 in participants = 18 years of age ... -
Randomized Double-blind Placebo-Controlled Multicenter Phase 3 Study to Evaluate the Safety Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in ... -
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in STANDARD RISK PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE (The ROADSTER 3 Study)
To evaluate real world usage of the ENROUTE Transcarotid Stent System when used in conjunction with the ENROUTE Transcarotid Neuroprotection System in patients at standard ... -
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 ... -
A PHASE 3 TRIAL OF FIANLIMAB (ANTI-LAG-3) AND CEMIPLIMAB VERSUS PEMBROLIZUMAB IN THE ADJUVANT SETTING IN PATIENTS WITH COMPLETELY RESECTED HIGH-RISK MELANOMA
This is a randomized, double-blind, phase 3 study in patients 12 years of age or older with completely resected high-risk melanoma in the adjuvant setting ... -
A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis
This is a multi-national, multicenter, double-blind, randomized, placebo-controlled study in patients with well-compensated NASH cirrhosis (CP-A, see Child-Pugh Classification, Appendix 6). Study subjects must have ... -
Site for Rheumatoid Arthritis-patient reported outcomes (RA-PRO) study for treatment strategies after methotrexate inadequate-response (MTX-IR)
Site for RA-PRO is a 12-month, 2-arm, open-label, RCT pragmatic study to test whether adding TNF-biologic strategy is superior to the alternative approach of small ... -
A Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiranin the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease with METAVIR Stage F2 to F4 Fibrosis
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of fazirsiran (TAK-999, previously called ARO-AAT) in the treatment ... -
A multicenter international randomized placebo controlled double-blind parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
OCEANIC-STROKE (study 20604) is a multicenter, international, randomized, placebo controlled, double-blind, parallel group, event driven phase 3 study. The purpose of this study is to ...