65 results
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…
Primary objective:To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with TCS in treating moderate-to-severe AD.Secondary objectives:To evaluate the efficacy of tralokinumab in combination with TCS on…
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…
Stage 1* To assess the safety and tolerability of single-ascending-dose levels of IW-6463 when administered to healthy subjectsStage 2* To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 when administered to healthy…
Part A: Determine safety and tolerability of FTX-1821 in healthy subjects. Part B and C: Determine safety and tolerability of FTX-1821 in FSHD patients.
Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…
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 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…
To compare invasive disease-free survival (iDFS) for ribociclib + ET versus placebo + ET in patients with HR-positive, HER2-negative, EBCwith high risk of recurrence.
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…
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…
Our primary objective is to investigate whether oxytocin administration can affect empathy and emotion recognition in healthy and antisocial adolescents. We expect that oxytocin will enhance empathy and emotion recognition in both healthy and…
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…
Efficacy and safety trial with S 44819 after recent ischemic cerebral Event
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…
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 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.
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…