20 results
The objective of this study is to assess the safety and efficacy of 2 dose levels of risankizumab versus placebo for the treatment of signs and symptoms of moderate to severe Hidradentitis Supperativa in adult subjects diagnosed for at least one…
The primary objective of the study is to compare the efficacy of risankizumab versus placebo for the treatment of signs and symptoms of PsA in subjects who have a history of inadequate response to or intolerance to at least one biologic therapy.
Primary Objective: To assess the agreement between the heart rate assessed with a dedicated cap with integrated PPG-leads and standard ECG monitoring using regular neonatal thoracic electrodes as reference technique.Secondary objectives:Does…
The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Main objective Monotherapy Cohorts (R/R CLL):• Identify the RP2D and the MTD of epcoritamab• Evaluate the safety and tolerability of epcoritamabExpansion Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]):• Assess the preliminary efficacy of…
Compare the clinical efficacy of Epcoritamab to SOC (R-GemOx or BR)
The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose…
Study M16-066 comprises three sub-studies:Sub-study 1: Randomized, double-blind, placebo-controlled maintenanceTo evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active…
Study M16-067 comprises two sub-studies:1) The objective of Sub-Study 1 are to characterize the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC) and…
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong progression-free survival (PFS) compared with 6 cycles of standard R-…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
The primary aim is to evaluate the effectiveness of bilateral toric IOL implantation versus bilateral monofocal IOL in patients that undergo cataract surgery and have a total corneal astigmatism >=0.75 and <=1.50D.
The objective is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.
The objective is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.
Sub-study 1: The objective of sub-study 1 is to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction…
Dose Escalation PhasePrimary - Evaluate the safety and tolerability of epcoritamab in combination with other agents Secondary- Characterize the PK properties of epcoritamab- To evaluate pharmacodynamic markers linked to efficacy and mechanism of…
The primary objective of the study is to compare the efficacy of risankizumab versus placebo for the treatment of signs and symptoms of PsA in subjects who have a history of inadequate response to or intolerance to at least one conventional…
Part 1:The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy.Part 2:The objective…
This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Dose Escalation (GEN3009 for R/R B-cell NHL Including CLL/SLL):- Determine the MTD with and/or determine the RP2D of GEN3009- Evaluate safety and tolerability of GEN3009Expansion (GEN3009 for R/R, DLBCL, FL, and CLL Cohorts):-Evaluate (preliminary)…