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A PHASE 2, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED TRIALTO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF PF-04360365 (PONEZUMAB) IN ADULT SUBJECTS WITH PROBABLE CEREBRAL AMYLOID ANGIOPATHY

Primary Objective:- To evaluate the efficacy of PF-04360365 (ponezumab) in subjects with probableCAA as compared to placebo on a BOLD fMRI measure of cerebrovascularreactivity.Secondary Objectives:- To evaluate the efficacy of PF-04360365 (ponezumab…

A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy

The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn*s Disease

To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn*s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8.

A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of CIDP compared with placebo. Data from this study will be used to support the registration of fingolimod in the indication of CIDP.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE

Primary objectiveThe primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn*s disease previously achieving clinical response or…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer.

The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…

A double-blind, randomised, placebo-controlled, Phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSIL

Primary Objective To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific,…

An Open-Label, Single Dose, 4-Period, 4-Way Randomized Crossover Study to Evaluate the Pharmacokinetics of Preliminary Market Formulations of MK-8408 in Healthy Adult Subjects.

Primary:1. To assess the pharmacokinetic profiles following single dose administration of MK-8408 administered as a PMF1 tablet by means of AUC0-*, AUClast, AUC0-24, Cmax, C24, tmax, and t* under fed conditions, following a high fat meal. 2. To…

A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator*s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator*s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed…

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects with Glioblastoma Multiforme

The evaluation of the safety and pharmacokinetics of ABT-414 in combination with radiation plus temozolomide or temozolomide alone for subjects with Glioblastoma Multiforme.

A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin

The primary objective is:Assess the efficacy defined as Composite Complete Response (CRc)The secondary objectives of this study are:* Assess safety and tolerability* Assess immunogenicity and pharmacokinetics* Progression-free survival (PFS),…

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background Cyclophosphamide or Rituximab Treatment

This study is set-up to evaluate the safety and tolerability of CCX168 in subjects with mild to moderate AARV on a background of cyclophosphamide treatment. It will assess the possibility to optimize the treatment with CCX168 and to reduce the side…

Long-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension

To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).

A PHASE I, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ESCALATING DOSES OF DMOT4039A IN PATIENTS WITH UNRESECTABLE PANCREATIC OR PLATINUM-RESISTANT OVARIAN CANCER

The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…

A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin

- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…

A Randomized, Double-blind, Placebo-controlled, Single Center Study of the Safety, Tolerability, Pharmacokinetics (Including Food Effects) of Single or Multiple Doses of ABT-639 in Healthy Adults and Elderly Subjects

Part I will assess the safety, tolerability and pharmacokinetics of single, escalating doses of ABT-639Part II will assess the effect of food on the pharmacokinetics of single doses of ABT-639Part III will asses the safety, tolerability, and…

A randomized double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety and pharmacokinetics of OCR 002 in healthy volunteers.

SADTo evaluate the safety and tolerability of ascending single doses (SAD) of OCR 002 administered as intravenous (IV) infusions in healthy volunteersTo evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and glutamine after a…

Durable-Response Therapy Evaluation For Early -or New-Onset Type 1 Diabetes.

Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…

The ASPECT-2 Trial: A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

Primary:* To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine…

A RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED, 5-WAY, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ONO-8539 IN PATIENTS WITH OVERACTIVE BLADDER

The primary objective of this trial is to compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24 hrs from baseline to 12 weeks.The secondary objectives of this trial will be:*To…