67 results
The primary objective is to demonstrate that glycemic control, as measured by hemoglobin A1c(HbA1c) at 52 weeks for LY2605541 is noninferior to insulin glargine, when each is combined with preprandial insulin lispro, in patients with type 1 diabetes…
The aim is to investigate whether a melting tablet that contains birch pollen allergen will decrease the hay fever symptoms and may alleviate the need for conventional allergy symptom-suppressing medication. The purpose of this specific study is…
The objective of the present study is to assess the effect of HTL0009936 on cognitive performance in elderly subjects with below average cognitive function. The oral pharmacokinetics of HTL0009936 shows a significant degree of variability between…
The primary objective of this study is to:* Evaluate the effect of GS-6615 on exercise capacity, as measured by Peak VO2 achieved during cardiopulmonary exercise testing (CPET), in subjects with symptomatic hypertrophiccardiomyopathy (HCM).The…
Primary objectives• To evaluate the systemic exposure of digoxin and furosemide after repeated topical CLS003 application in otherwise healthy subjects with multiple cutaneous warts;• To assess the safety/tolerability profile of CLS003.Secondary…
To evaluate the efficacy and safety of eASCs compared to placebo for the treatment of complex fistulas in Crohn*s disease over a 24- and 104-week period.
This is a placebo- and active-controlled dose-range-finding study which isalso designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twicedaily versus placebo as an adjunct therapy to L-dopa when administered to subjectswith moderate…
The primary objective of this study is to evaluate the tumor response of stable disease (SD), partial response, or complete response at at 12 weeks (according to RECIST 1.1 criteria) in two separate cohorts representing molecularly distinct subsets…
The primary objective of the study is evaluating the safety, tolerance and anti-lymphoma activity of the anti-CD79b-MMAE conjugate (DCDS4501A) and the anti-CD22-MMAE conjugate (DCDT2980S), both given in combination with Rituximab once every 4 weeks…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
The primary objective of this study is to evaluate the overall response rate (ORR) of LY2875358 plus erlotinib therapy and LY2875358 monotherapy in patients with met proto-oncogene (hepatocyte growth factor receptor) (MET) diagnostic positive (MET…
This is a active-controlled dose-range-finding study which is also designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twice daily during long term use as an adjunct therapy to L-dopa when administered to subjects with moderate to…
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in mean monthly migraine days, in subjects with episodic migraine.hypothesis: In subjects with episodic migraine, AMG 334 has a greater reduction from baseline in mean…
To assess the potential of the PET-tracer [11C]SMW139 to investigate the role of P2X7R, a cell surface receptor upregulated in activated microglia, in neuroinflammation in PD. The aim is to find the optimal tracer kinetic model which can be used to…
PHASE IIPrimary ObjectiveThe primary objective of the Phase II portion of the study is to estimate the efficacy as measured by radiographic progression-free survival of IPATASERTIB (GDC-0068) (dosed at either 400 mg or 200 mg daily) + abiraterone…
Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…
The primary objective of the study is to evaluate the safety and tolerability of single-dose IV infusion of BIIB033 administered to healthy adult volunteers.Secondary objectives of this study are:* assess the single dose PK profile of BIIB033 *…
The primary objective of this study is to compare overall survival (OS) in patients with metastatic colorectal carcinoma (CRC) when treated with FOLFIRI in combination with placebo versus FOLFIRI in combination with ramucirumab DP.Secondary…
The primary objective of this phase III study in subjects with metastatic and/or unresectable GIST who have progressed after therapy with at least imatinib and sunitinib is to compare the treatment groups in terms of Progression-Free Survival (PFS…
The objective of the present phase 2 trial is to evaluate the safety, pharmacodynamics (effect on HPA axis and calcium metabolism) and pharmacokinetics of LEO 90100 in adolescent subjects with plaque psoriasis. Subjects will be treated once daily…