14 results
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…
To evaluate the long-term safety, tolerability and efficacy of ArikaceTM 590 mg for a maximum 12 cycles administered once daily, where each cycle consists of 28 days on treatment followed by 28 days off treatment.
Primary objective:To compare the effects of quick starting a combined oral contraceptive on follicular growth and hormonal parameters after ellaOne® or placebo intake.Secondary objective:To compare the effects of quick starting a combined oral…
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 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.
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.
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.
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 M16-067 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…
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…
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…
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…