11 results
- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
Primary: To evaluate the efficacy of tisagenlecleucel therapy as measured by overall response rate by investigator assessment.Secondary: Duration of response, event free survival, relapse free survival, overall survival, safety, kinetics,…
Primary ObjectiveThe primary objective of this study is to evaluate the initial efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).Secondary ObjectivesThe secondary objectives…
The study is divided into two sections:Part A is a healthy volunteer controlled observational study to determine the course of the disease over time to:- Evaluate disease-related biomarkers in psoriasis when compared with healthy volunteers;-…
Primary objectiveTo compare the efficacy of brodalumab with guselkumab in adult subjects with moderate to severe plaque psoriasis and prior inadequate response to ustekinumab. Secondary objectives:To evaluate the efficacy of brodalumab compared with…
Primary ObjectivesThe primary objective of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged >=6 through <18 years with chronic plaque psoriasis.Secondary ObjectivesThe secondary objectives…
The study will be performed in 2 parts, Part 1 and Part 2. Part 2 has been clinically completed. The remainder of this document concerns Part 1 only. The purpose of Part 1 of this study is to determine the reversal of the blood thinning effects of…
To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease progression / stable disease at or after the week 12 assessment; or death at any time.
Induction Study 1 (Phase 2b Induction Dose-ranging Study)ObjectivesPrimary ObjectivesThe primary objectives of this study are, in participants with moderately to severely active UC:* To evaluate the efficacy of guselkumab as induction therapy.* To…
To explore the effect of treatment with guselkumab in subjects with Familial Adenomatous Polyposis (FAP) on rectal/pouch polyp burden (the sum of the polyp diameters)