94 results
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 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.
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 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 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…
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/…
• To evaluate the safety and efficacy of multiple doses of XPF-001 (400 mg bid) for relief of pain in patients with IEM.• To evaluate the efficacy of multiple doses of XPF-001 (400 mg bid) for relief of vasomotor signs in patient with IEM.• To…
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 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 primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.Key secondary objectives are to evaluate OS in the epidermal growth factor receptor (EGFR) wild type…
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 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…
Efficacy and safety trial with S 44819 after recent ischemic cerebral Event
The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
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…
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
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…
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…
The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…