107 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…
To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) and SCBMs non-straining (NS) per week in subjects taking World Health Organisation (WHO) step II/…
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 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…
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…
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 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…
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.
Main objectives Part 1• To evaluate the safety and tolerability of a single oral dose of HTL0018318, administered at one of at least three ascending dose levels (maximum of 8 ascending dose levels), in healthy younger adult male subjects.• To…
Phase 2: To evaluate progression-free survival (PFS) as the primary efficacy measure of MLN1117 plus docetaxel versus docetaxel alone in patients with advanced NSCLC
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…
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…
The primary objective of this study is to assess the hemostatic efficacy and safety of rVWF with or without ADVATE in subjects (* 18 years) diagnosed with hereditary severe VWD undergoing major and minor elective surgical procedures.
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 *…
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…
The primary objectives of this study are to:* Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using an intermittent…
To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.
CD is a chronic, relapsing-remitting, inflammatory disease of the GI tract. Some patients may have persistent clinically active disease. The current treatment options for patients with moderate to severe CD, refractory to standard therapies that…
To evaluate the pharmacodynamic (PD) effects of the study treatments (ACT-541468 50 mg, ethanol at a blood level of 0.6 g/L for 5 h) as co-administration in 4 different combinations (ACT-541468 plus ethanol, ACT-541468 alone, ethanol alone, and…
Primary objectiveTo evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.Secondary objectivesTo evaluate the efficacy…