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A Global Study of a Single, One-Time Dose of AVXS-101 Delivered to Infants with Genetically
Diagnosed and Pre-Symptomatic Spinal Muscular
Atrophy with Multiple Copies of SMN2

Safety:* Evaluate the safety of AVXS-101 through incidence of adverse events (AEs) and/or serious adverse events (SAEs)* Evaluate the safety of AVXS-101 based on the change from baseline in clinical laboratory parametersEfficacy objectives will be…

Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients with Moderate to Severe Asthma who Completed the TRAVERSE-LTS12551Clinical Trial

The primary objective of this study is to describe the long-term safety of dupilumab in the treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial, TRAVERSE-LTS12551.

Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.

To determine if SSA are effective in decreasing transfusion requirements and improving quality of life while being cost-effective.

An open-label extension study to evaluate the long-term safety,
tolerability, and efficacy of REGN3918 in patients with paroxysmal
nocturnal hemoglobinuria

The primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis (ie, proportion ofpatients achieving lactate dehydrogenase (LDH) * 1.5× upper limit of normal (ULN) over 26 weeks) of…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA)

The purpose of this study is to investigate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at up to 16-week intervals to treatment-naive patients with nAMD.

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy

Objectives:Primary objective:To evaluate the efficacy of the 3 selected dose regimens of Padsevonil (PSL) administered concomitantly with up to 3 antiepileptic drugs (AEDs) compared with Placebo for treatment of observable focal-onset seizures in…

Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002

Is to evaluate long-term safety of oral levosimendan in amyotrophic lateral sclerosis (ALS) patients.

A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients with Mild or Moderate Hemophilia A without FVIII Inhibitors

This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in patients of all ages with mild (FVIII level between > 5% and < 40%) or moderate hemophilia A (FVIII level between >= 1% and…

A Phase III, Open Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma

The primary objective of this study is to compare the overall survival (OS) associated with rAd-IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM…

Peri-Operative ISchemic Evaluation-3 Trial

Perioperative bleeding in the setting of noncardiac surgery is strongly associated with 30-day cardiovascular complications and mortality. Trial evidence suggests that intravenous TXA reduces perioperative bleeding and transfusion in orthopedic…

Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

To demonstrate that QIV-HD induces an immune response that is superior to the responses induced by QIV-SD for all 4 virus strains 28 days post-vaccination in subjects 60 to 64 years of age and in subjects 65 years of age and older.

A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in patients with PPMS, including patients later in their disease course.

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

This study has been transitioned to CTIS with ID 2022-500785-10-00 check the CTIS register for the current data. 1) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)2) To compare…

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival (OS)

A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

The purpose of this study is to compare the effectiveness of treatment Arm A and Arm B by measuring the event free survival (EFS) and pathological complete response (pCR). EFS is defined as the time from the first treatment dose that the patient…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis. SELECT-GCA

This study has been transitioned to CTIS with ID 2023-505476-29-00 check the CTIS register for the current data. This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week…

A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

Primary Objective: • To compare efficacy of once-weekly KRd (56 mg/m2 ) to twice-weekly KRd (27 mg/m2) in subjects with RRMM with 1 to 3 prior lines of therapyKey Secondary Objectives: • To compare progression-free survival (PFS) between treatment…

A phase 3b, prospective, open-label, uncontrolled, multicenter study on long-term safety and efficacy of rVWF in pediatric and adult subjects with severe von Willebrand disease (VWD)

To evaluate the efficacy of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in adult and pediatric / adolescent subjects (aged 12 to <18 years) during the…

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma (KEYNOTE 966)

This study has been transitioned to CTIS with ID 2023-506657-38-00 check the CTIS register for the current data. To compare pembrolizumab plus gemcitabine plus cisplatin to placebo plus gemcitabine plus cisplatin with respect to overall survival (OS…