20 results
To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence…
The primary objectives of this study are to assess whether 80 mg ixekizumab every 2 weeks (Q2W) is:• noninferior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by proportion of patients…
1. Primary Objectives of the study: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects * 12 to < 18 years of age with moderate to severe…
The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease who have failed or are intolerant to one or more tumor…
To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.
Primary objective: 1. To evaluate the effect of ustekinumab in patients with moderate to severe hidradenitis suppurativa (Hurley II-III), measured by disease specific score systmes: Sartorius/HS-LASI and PGA 2. To evaluate possible changes in scores…
Primary Objective: The primary objective of this exploratory trial is to evaluate the comparative safety through Week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: discontinuation of methotrexate…
MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…
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
The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.
Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…
ObjectivePlease describe:• the specific goal to be reached by the study• the hypothesis to be answered by the studyThe overall aim of the study is to determine which downstream cellular and molecular pathways involved in PsA pathogenesis are…
The primary objective for this study is as follows:* To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used incombination with bendamustine compared with bendamustine alone in patients with indolentNHL refractory to…
A *treat to target* strategy has been advocated as an optimized management approach for various diseases, by which strictly defined treatment targets facilitate decision making in clinical practice. Key to the success of this treatment strategy is…
INDUCTION STUDY Primary Objectives:* To evaluate the efficacy of intravenous (IV) ustekinumab in inducing clinical remission in subjects with moderately to severely active UC.* To evaluate the safety of IV ustekinumab in subjects with moderately to…
The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…
The primary objective is to evaluate the achievement of clinical response at Week 16 following a single IV re-induction dose of *6 mg/kg ustekinumab, compared with continuing regular SC q8w 90 mg ustekinumab administration, in participants 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…
The objective of this trial is to show that Ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment in biologic naïve subjects with moderately-to-severely active CD who have previously failed or were…
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…