14 results
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…
* To decrease mortality in MS-LCH by an early switch of patients with risk organ involvement, who do not respond to front-line therapy, to a more intensive treatment (Stratum III or Stratum IV).* To reduce reactivation rates and permanent…
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…
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 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
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 aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…
The goal of the fenebrutinib development program in MS is to evaluate the benefits and risks of fenebrutinib treatment across the spectrum of patients with MS. Based on the existing toxicology, pharmacology, and clinical experience with fenebrutinib…
Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of subjects receiving standard of care (SOC) chemotherapy• To compare overall survival (OS) of blinatumomab…
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)
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…