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Phase IIa, 2:2:1 randomised, double-blind, placebocontrolled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

The primary objective of the study is:Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.The Secondary objective is:Evaluate the efficacy and pharmacokinetics (PK) of 6.0 mg/kg…

Efficacy analysis of several drugs in a humanized mouse model of psoriasis

In this study, the efficacy of different type drugs, on the development of the psoriatic process in the humanized mouse model for psoriasis, will be evaluated. These different, registered drugs intervene at different levels of the psoriatic process…

Efficacy of a novel compound in a humanized mouse model of psoriasis

ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated.

A Single-Center, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects

The purpose of this research is to investigate the safety and tolerability of MSB0010841. This study will also investigate how quickly and to what extent the study medication is absorbed and eliminated from the body (this is called pharmacokinetics…

Phase IIB, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active
Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous
Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid
Arthritis with Inadequate Response to Methotrexate.

Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…

Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab

Until recently there were only few therapeutic options to treat AS. Efficacy is proven for several tumor necrosis factor (TNF)-blocking agents, including golimumab. 2-8 However, up to now, the efficacy of golimumab treatment on EAMs, like anterior…

An open label, single dose study to assess the pharmacokinetics of a microdose of recombinant human placental alkaline phosphatase (hRESCAP, part 1) followed by a randomized, double-blind, placebo-controlled, parallel, single ascending dose, first-in-human study to assess safety and tolerability of hRESCAP (part 2) in healthy male volunteers

Part 1:- To assess the PK of a single iv microdose (<=30 nmol) of recombinant human placental alkaline phosphatase (hRESCAP);- To assess if microdosing is a suitable technique to predict the PK of recombinant proteins using hRESCAP as model…

A dose-response evaluation of ALK tree allergy immunotherapy tablet

The aim is to investigate whether a melting tablet that contains birch pollen allergen will decrease the hay fever symptoms and may alleviate the need for conventional allergy symptom-suppressing medication. The purpose of this specific study is…

Effect of synbiotics in infants with atopic dermatitis up to 7 years of life

Primary study objectiveTo investigate the prevalence of asthma in children up to 7 years of age with atopic dermatitis in infancy who received either Nutrilon Pepti with synbiotics or Nutrilon Pepti without synbiotics during 12 weeks in their first…

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.

The primary objective of the study is to evaluate the safety and tolerability of CCX354-C in subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.The secondary objectives of the study are to evaluate the…

Beyond conventional treatment of Atopic eczema in infants: Management By specific prObiOtic strains. A double blind placebo-controlled trial.

To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in vitro and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD…

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…

A PHASE 1, THREE-PART, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF AQX-1125 IN HEALTHY HUMAN SUBJECTS

Primary:To assess the safety and tolerability of single and multiple oral ascending doses of the study drug in healthy human subjects (Part 1 and Part 2)To assess the effect of food on the absorption and pharmacokinetic (PK) profile of the study…

Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of abatacept in patients with active rheumatoid arthritis.The secondary objectives of this study are to (I) assess clinical…

A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

The primary objective of the study is to evaluate the long term safety of SAR153191 in patients with RA on top of DMARDs. The secondary objective of the study is finding the percentages of patients who reach ACR20, DAS28 and EULAR response overtime.

Effects of Induced Hypothermia on Respiratory parameters and Immunological function

Observational part on respiratory parametersThe primary objective of this study is to study the effect of hypothermia and rewarming on P/F ratio as a measure of oxygenation and on end tidal CO2 as a measure of ventilation during mechanical…

Serum antibody response to influenza A in children with Down syndrome

Measuring specific antibody titers against influenza A (subtype H1N1 and / or seasonal vaccine) in DS children. DS anti-influenza antibody titers will be compared with controls available from the same laboratory.

The effects of plant stanols on the immune function of asthma patients

The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients

Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.

Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…

A partly blinded single center trial studying the effect of daily oral treatment with 30 mg prednisolone during two weeks on metabolic and disease activity parameters in patients with severe chronic atopic dermatitis and in healthy volunteers

Primary objectives:• To explore whether daily oral treatment with 30 mg prednisolone modulates biomarkers for adverse metabolic effects in a similar manner in patients with chronic atopic dermatitis as compared to healthy volunteers.• To determine…