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Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

The effect of moderate alcohol consumption on a human in vivo model of low-grade systemic inflammation in young, normal-weight men

Primary objective: To explore whether prolonged moderate alcohol consumption affects in vivo cytokine response after a low dose of LPS in young, normal-weight men.Secondary objectives: To explore whether prolonged moderate alcohol consumption-…

The effect of acute moderate alcohol consumption after a psychological stressor on the stress response in men

Primary objectives: Stress response: To determine whether acute alcohol consumption shortly after a psychological/mental stressor attenuates the stress response recovery.Cholinergic status: To determine whether prolonged moderate alcohol consumption…

MIPS Follow up - Local continuation of an observational, double-blind, follow up study as an extension of a randomised double-blind controlled study with a parallel group design on the effect of formula feeding (IF?FOF) supplemented with a mixture of immunologically active neutral and acidic oligosaccharides in healthy term born infants during their first year of life (during MIPS1) on the incidence of atopic diseases and infections around their 3rd year of life until the completion of their 7th

Has the supplementation of oligosaccharides in the first year of life an effect on the incidence of atopic diseases and infections from the 5th until the 7th year of life in healthy children

Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS)

To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced trained immunity as a possible preventive approach against COVID-19

Explorative study to the effect of BCG booster methods on the induction of trained innate immunity

The objective of the study is to determine the effect of BCG revaccination and high dose BCG vaccination on the induction and course of innate immune memory.

The effects of human endotoxemia on the functional capacity of hematopoietic stem and progenitor cells

Primary objective: - To characterize hematopoietic progenitor cells in human bone marrow before and after endotoxemia (by evaluating hematopoietic lineage differentiation and functional capacity). Secondary Objectives: - To determine the effects of…

EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS

Primary:* To assess the sustained efficacy of tofacitinib versus placebo in sJIA patients, as measured by time to sJIA flare in the double-blind randomized withdrawal phase.Secondary:* To assess efficacy of tofacitinib versus placebo in sJIA…

Transcutaneous electrical nerve stimulation in persons with MS

Primary Objective:What is the effect of a four-weeks combined TENS and exercise program, in comparison with no training, an exercise program or TENS only program, on the walking capability, perceived walking disability, and sense of fatigue of pwMS.…

A phase 1, first-in-human, 2-part, randomized, double-blind, placebo
controlled, single ascending dose and sequential, open-label, multiple
ascending dose study to evaluate the safety, tolerability,
pharmacodynamics, and pharmacokinetics of VIS171 in healthy
participants and participants with autoimmune disease(s)

The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…

A randomized, part A partial blinded and part B double blinded, placebo-controlled 24-week clinical study to evaluate the efficacy and safety of nomacopan therapy in adult patients with bullous pemphigoid receiving adjunct oral corticosteroid therapy (ARREST-BP)

Primary Objective:* confirm the dose of nomacopan and sample size for Part B and evaluate the rank order of secondary endpointsOther Objectives:* compare nomacopan with adjunct OCS to placebo with adjunct OCS in achievement of Complete Remission of…

A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

This study has been transitioned to CTIS with ID 2024-511115-25-00 check the CTIS register for the current data. Primary Objective:The primary objective of this study is:• To evaluate the efficacy of namilumab in subjects with chronic pulmonary…

A Randomized, Open-label, Placebo-Controlled, Parallel-Group Study to Evaluate the Immune System's Response to the Polyvalent Pneumococcal Vaccine (PNEUMOVAX 23) in Healthy Participants Receiving Intravenous Efgartigimod or Placebo.

The purpose of this study is to investigate the effect of the study compound efgartigimod on the immune system's response to vaccination with Pneumovax 23. We also investigate how safe efgartigimod is and how well it is tolerated when it is…

A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)

Primary ObjectivesThe primary objective of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged >=6 through <18 years with chronic plaque psoriasis.Secondary ObjectivesThe secondary objectives…

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of OMS1029 with single-dose intravenous and subcutaneous administration in healthy subjects

In this study we will investigate how safe the new compound OMS1029 is and how well it is tolerated when it is used by healthy subjects.We also investigate how quickly and to what extent OMS1029 is absorbed, transported, and eliminated from the body…

A randomized, double-blind, placebo-controlled crossover study to assess the effect of 12-week fibre supplementation on mixed-meal challenge response in adults

Primary ObjectiveTo relate microbiome modulation by dietary fibre supplementation, as measured by 16S rRNA sequencing, to changes in response to a mixed-meal metabolic challenge (PhenFlex) as measured by composite biomarker score.Secondary…

A Phase 1, Randomized, Single-Center Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of R289 in Healthy Subjects.

Part 1 - Single Ascending Dose (SAD) Capsule Formulation:Primary objective:To investigate the safety and tolerability of single oral doses of R289 capsules in healthy subjects.Secondary objective:To characterize the pharmacokinetic (PK) profiles of…