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A Phase I, Randomized, Single-Center Study to Investigate the
Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Profiles of Single and Multiple Doses of R924548 in Healthy Human Subjects

Primary: to investigate the safety and tolerability in healthy subjects of single and multiple ascending oral doses of R548 formulated and dosed as an aqueous suspension or aqueous solutionSecondary: - to characterize the single dose and steady…

Prospective follow-up study of golimumab treatment in psoriatic arthritis

To determinate the efficacy and safety of golimumab in patients with psoriatic arthritis in daily clinical practice prospectively. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study and…

Optimising outpatient care in mild to moderate psoriasis by a newly developed *Topical Treatment Optimising Programme* - an international study using Daivobet®/Dovobet® Gel (*PSO-TOP*)

The objective of the study is to assess the value of the *Topical Treatment Optimising Programme* in the topical treatment, which will be use together with the standard treatment, of insufficiently treated mild to moderate psoriasis after 8 weeks of…

Efficacy analysis of a novel compound in a humanized mouse model for psoriasis and development of the humanized mouse model

In this study the effect of a novel compound on the development of psoriasis in the humanized mouse model is investigated. In addition, the material of 3 donors wil be used to develop the mouse model further and train technicians. The focus will be…

Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml

The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…

A double blind, placebo controlled Phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of subjects with sarcoidosis

ARA290 is a new drug against neuropathic pain and was succesfully tested in previous studies on patients with neuropathic pain due to diabetes and sarcoidosis. The current study involves sarcoidosis patients with pain due to neuropathy. The purpose…

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

The purpose of this research study is to investigate how safe the compound is and how well the compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body (this is…

A multicenter, double-blind, randomized, active controlled, parallel-group study
to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions
compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis
treated with methotrexate (MTX)

Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of Radiolabeled [14C] R924548 Following Single Oral Dose Administration in Healthy Male Subjects

- To assess the absorption, distribution, metabolism and excretion of R924548 after a single oral dose- To assess the safety and tolerability of R924548 after a single oral dose

Effects of orally administered Beta-Glucan on leukocyte function in humans, a pilot study

The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex-vivo responsiveness of leukocytes…

A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, 4-Period Crossover ECG Study to Evaluate the Effect of VX 509 on QT/QTc Interval in Healthy Adult Subjects

The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…

A randomized, double-blind, placebo-controlled study of ascending single low doses of LPS administered intravenously to healthy volunteers to assess the dose-response relation.

To assess the relationship between administration of low doses of LPS (0.5, 1 and 2 ng/kg bodyweight) and the inflammatory response (cytokine levels and hs-CRP) in healthy male volunteers;To assess the duration of tolerance/paralysis of the immune…

A DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF A SUBCUTANEOUS DOSE OF SHK-186 IN HEALTHY SUBJECTS

The purpose of the study is to investigate to what extent ShK-186 is tolerated. How quickly and to what extent ShK-186 is absorbed and eliminated from the body (this is called pharmacokinetics) will be investigated.

SOM230 Graves Orbitopathy pilot trial

Therefore, we aim to investigate in a pilot trial the effect of SOM230 on predefined endpoints in patients with moderate to severe GO whom have contraindications for prednisolone therapy or decline from prednisolone therapy for other reasons.

Effects of oxygen status on Hypoxia Inducible Factor 1-α. A pilot proof of principle study.

The primary objective of the study is to determine the effects of hyperoxia and hypoxia in healthy volunteers on kinetics of HIF1α mRNA in circulating leukocytes. Secondary objectives are to determine the effects of hyperoxia and hypoxia on HIF1α…

MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS

To evaluate the safety and tolerability of SC TCZ monotherapy and/or in combination with MTX or other non-biologic DMARDs comprising AEs, physical examination, vital signs, and clinical laboratory assessments, including immunogenicity, in patients…

A PHASE 1, OPEN-LABEL STUDY OF THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-LABELED IPI-145 AND THE ABSOLUTE BIOAVAILABILITY OF IPI-145 IN HEALTHY SUBJECTS

Primary: To evaluate the absorption, distribution, metabolism and excretion of IPI-145 following a single oral dose of 14C0IPI-145.To determine the absolute bioavailability of IPI-145 following a single oral dose of IPI-145 and an intravenous…

Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.

To determine the proportion of patients with RA, AS or PsA maintaining minimal disease activity (MDA) after dose interval prolongation of etanercept. Secondary objectives: To study the cost-effectiveness of tapering down etanercept treatment, to…

Immunological response to Hepatitis B vaccination in obsessive compulsive disorder patients receiving high doses of serotonin reuptake inhibitors

The main objective of this study is to1) Determine the immunological response to hepatitis B vaccination in OCD patients that are treated with 60 mg/d paroxetine and2) Compare this response to the immunological response to hepatitis B vaccination in…

A pilot study on efficacy and safety of 100 ug start dose wasp venom immunotherapy (VIT)

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