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A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Primary:* To demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment in study participants with primary ITPSecondary:* To assess the safety and tolerability of rozanolixizumabExploratory:* To evaluate the clinical efficacy as…

Protecting against Respiratory tract Infections through human Milk Analysis.

Primary objective:1. To identify the components in human milk (e.g. nutrients, oligosaccharides, fatty acids and (pathogen specific) immunoglobulins) that have a protective effect against respiratory tract infections during the first year of life.…

EFFECTS OF ANTIBODY REMOVAL BY IMMUNOADSORPTION ON THE IMMUNE PHENOTYPE IN PATIENTS WITH ANTIBODY MEDIATED DISEASES - A *TARGET-TO-B* STUDY

1) To study the effects of antibody removal by immunoadsorption on the immune phenotype over time in patients with B-cell related autoimmune diseases such as MG, AAV, anti-GBM disease, cryoglobulinemic vasculitis and other refractory antibody-…

Immune response during and after reactive hemophagocytic lymphohistiocytosis (HLH)

We aim to find immune defects and related genetic variants in patients who have recovered from secondary HLH

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to
Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with
Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or
Branebrutinib Treatment Followed by Open-label Abatacept Treatment in
Subjects with Active Rheumatoid Arthritis.

pSS: • To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS• To compare the safety and tolerability of branebrutinib with PBO in subjects with pSSRA: • To compare the efficacy of branebrutinib with PBO…

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring

To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.

Comparison of subcutaneous and intravenous retreatment with ultra-low dose rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial

The aim of this study is to investigate non-inferiority of rituximab SC 336 mg to rituximab IV 200 mg.

Pathogenic cells and mediators involved in chronic inflammatory skin diseases

Determine the frequency, phenotype and function of disorder-related immune cells, or levels of immune molecules in skin and peripheral blood of patients with inflammatory skin diseases, during the active phase of disease prior to and/or at any time…

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Coadministration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

Range-Finding and Pilot Study For: Extended Fragrance Ingredients Surveillance Study (EFISS) - Surveillance Study to Monitor the Frequency of Contact Allergy to a Defined Group of Fragrance Ingredients with a View to Providing Reliable Information on Trends

To design an industry-sponsored surveillance study incorporating both additional and existing materials that has the possibility of identifying trends in the incidence of skin contact allergy.

A First-in-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous Dose Levels of ARGX-117 and Subcutaneous Dose Levels of ARGX-117 Co-Mixed with Recombinant Human Hyaluronidase PH20

This is the first clinical study in which ARGX 117 is administered to humans. The purpose of this study is to investigate how safe the new compound ARGX-117 is and how well it is tolerated when it is administered to healthy volunteers. It will also…

Mapping the peritoneal immune system to identify novel immunomodulatory treatment options for diseases with peritoneal involvement.

AimThe MAPS study aims to unravel the immune composition of the human peritoneal cavity and the tumor immune environment in peritoneal metastasized gastric and colorectal cancer. The overarching aim is to find new targets for immunotherapy for this…

A Phase II, randomized, multi-center, placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud*s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc)

Primary:To determine the safety and efficacy of GS-248 versus placebo on RP in subjects with SSc.Secondary:To determine the efficacy of GS-248 on peripheral vascular blood flow in subjects with SSc and RP.Exploratory:• To explore the…

[18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis.

Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.Secondary objectives are:- Assessment of the relationship between…

Immunome project consortium for autoinflammatory disorders

Main Objectives: To collect clinical data and biological samples derived from blood (plasma, serum, cells and DNA) as well as urine and stool to perform multi-omic and functional biological assays. The resulting data will be integrated and analyzed…

A Phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma

To assess the effect of dupilumab on sleep, to evaluate the effect of dupilumab on additional patient reported sleep outcomes, on objective sleep assessment, asthma symptoms, long function and the safety of dupilumab.

Walking energetics and fatigue in persons with rheumatoid arthritis and osteoarthrosis

To understand walking-related factors that contribute to fatigue and the relationship with total physical activity and social participation in daily life among pwRA and pwOA.

Neuroimage in patients with Breast Implant Illness (BII), an explorative pilot fMRI-study

The aim of this pilot study is to explore the structure and function of brain regions associated with the pain matrix in Breast Implant Illness (BII). This pilot study will be the foundation for grant application for future research.

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…

AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS

The primary objectiveTo evaluate the efficacy of eculizumab in the treatment of pediatric refractory generalized myasthenia gravis (gMG) based on change from Baseline in the Quantitative Myasthenia Gravis score for disease severity (QMG).The…