14 results
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
To compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
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…
Primary objective: To investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin at week 16 compared to baseline (t=0).Secondary objectives:- To determine the efficacy of 4 doses of guselkumab of…
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
Primary objective:- To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC inductionSecondary objectives:- To evaluate the efficacy of guselkumab SC across a range of outcome measures- To evaluate the safety…
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…
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 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…
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 Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To evaluate the safety of guselkumabSecondary Objectives:Phase 2:- To evaluate the dose-response of guselkumab to inform…
Primary:Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA. Secondary:Evaluate safety of ustekinumab and guselkumab in jPsAEvaluate immunogenicity of ustekinumab and guselkumab in jPsA
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)