40 results
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…
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.
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…
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…
To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.
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…
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…
The objective of this study is to examine the influence of a single dose of fluoxetine and of movement observation on cortical activity, and to relate the changes of the activity of the brain to muscle activation, motor function and motor control in…
We expect that in people with multiple sclerosis the processing of energy substances such as sugars (energy metabolism)i n the brains is not optimal . In our view this could explain the progressive deterioration of the disease. Currently there are…
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…
Objective of the study is to measure the effects of long term fluoxetine administration on brain- and muscle activity in combination with the effects on motor function. Main questions are:(1) Influences long-term administration of fluoxetine…
Documentation of the patients' functional recovery and quantification of fusion after implantation of 3-D trabecular titanium cages on the short and long term. These data will be compared with the recently performed randomized CASCADE trial on…
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 objective of this study is to confirm that the dissolution profiles of a sugar-free and sugared lozenge containing CPC/benzocaine (1.4mg/10 mg) are comparable following a single dose in healthy adult subjects.The secondary objectives of…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Part 1 - Single Ascending Dose (SAD):Primary objective:• To evaluate the safety and tolerability of single oral doses of THB001 in healthy subjects.Secondary objectives:• To characterize the plasma pharmacokinetic (PK) profile of single oral doses…
* to evaluate the safety and tolerability of Lu AF90103 following single ascending intravenous (i.v.) doses* to investigate the pharmacokinetics (PK) of Lu AF90103 (prodrug) and Lu AF88361 (drug) in plasma and cerebrospinal fluid (CSF) following…
Primary objectives:To identify and quantify the excretion pathways of oral ASTX029, including the mass balance and the excretions in urine and feces (Period 1).To determine the absolute oral bioavailability (F) of ASTX029 under fasting conditions (…