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Failing maternal-fetal tolerance in SLE: finding the molecular mechanisms behind pregnancy complications

Primary Objective:Delineate the differences in cellular composition and function at the maternal-fetal interface in patients with SLE compared to healthy women Secondary Objectives:- Establish a novel in-vitro model to study cell-cell interaction at…

Regulating Rheumatoid Arthritis

The aim of this study is to better understand various prerequisites for the development, implementation, and immunological monitoring of immune regulation restoring therapies in RA patients. To meet this aim, the study is divided into four equally…

Value based health care in systemic sclerosis: what is the optimal follow-up for patients with systemic sclerosis?

To evaluate in SSc patients with low risk for disease progression 1) whether assessment in an outpatient clinic setting is an acceptable alternative for evaluation in the Care Pathway. Outcome parameters we will evaluate include 1) health care…

A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and
tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and
adults with macrophage activation syndrome (MAS) in Still*s disease (including systemic
juvenile idiopathic arthritis and Adult onset Still*s disease) or with MAS in Systemic lupus
erythematous

This study has been transitioned to CTIS with ID 2024-516153-52-00 check the CTIS register for the current data. Primary objective: To demonstrate efficacy of emapalumab in the treatment of patients in:• Cohort 1: Macrophage activation syndrome (MAS…

Treat-to-target in systemic lupus erythematosus: a pilot study

The primary objectives of the study are as follow:1) To assess usability and adherence to a T2T strategy implemented through a digital e-health tool website (i.e. do physicians work through all aspects of the website and take part in all the T2T…

A MULTIPART EXPLORATORY STUDY TO EVALUATE SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS

The Galvani Splenic Neuromodulation System consists of a lead, rechargeable implantable pulse generator, external components and accessories. The system is designed to deliver electrical stimulation to the splenic NVB in patients with moderate to…

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…

Interferon, complement and immune cell imbalances in pregnant women with systemic autoimmune diseases

Overall aimIdentify immunologic imbalances, with a focus on IFN, NETs, complement and lymphocyte subsets during pregnancy in women with systemic autoimmune diseases.HypothesisWe hypothesize that increased IFN activation and NET formation in patients…

Can we improve the management of Juvenile PsA patients by using a different disease activity measure?

Primary goal: to determine whether a combined disease activity measure correlates better with disease burden than the current disease measure. Primary study question: does the minimal disease activity JADAS (MDA-JADAS) correspond to the MDA…

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI*N METHYL D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI*LEUCINE RICH GLIOMA INACTIVATED 1 (LGI1) ENCEPHALITIS

This study has been transitioned to CTIS with ID 2023-504226-18-00 check the CTIS register for the current data. This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in each of…

A feasibility study to suppress myocardial [18F]-FDG uptake by pre-administration of pure caffeine

To investigate the tolerability and effect of pure cafeine food suplement pre-administration on myocardial [18F]FDG uptake suppression.

A randomized, double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment

The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…

A phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939

Primary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (two dose levels using EC2 capsules) on the immune system.Secondary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (…

Predicting by means of in vitro tests the treatment response in patients with MG

The first aim of this study is to use an in vitro approach using patient*s derived material to accurately and rapidly predict the optimal therapeutic approach that will predict a good clinical response in individual patients. The second aim of this…

A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis.

Single dosingPrimary objective:• To evaluate the safety and tolerability of single ascending doses of SOL-116 in healthy subjects and rheumatoid arthritis (RA) patients.Secondary objective:• To determine single dose pharmacokinetic (PK)…

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

This study has been transitioned to CTIS with ID 2024-512785-33-00 check the CTIS register for the current data. Primary objective: To evaluate the clinical improvement of efgartigimod PH20 SC treatment compared with placebo, in addition to standard…

A multicenter study of secukinumab, with a randomized double-blind, placebo-controlled withdrawal-retreatment period, to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission

This study has been transitioned to CTIS with ID 2023-509320-17-00 check the CTIS register for the current data. * To evaluate whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in…

Predicting the outcome of a demyelinating event

To identify prognostic factors for disease course and severity, as soluble and cellular biomarkers, immunological, genetic, radiological and demographics factors.

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis

This study has been transitioned to CTIS with ID 2023-506039-13-00 check the CTIS register for the current data. OBJECTIVESPrimary Objective• To assess the efficacy of efzofitimod in patients with pulmonary sarcoidosis Secondary Objectives• To…

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold
Agglutinin Disease (CAD)

Primary objective:- To demonstrate the efficacy of twice-weekly s.c. 1080-mg infusions of pegcetacoplan compared with that of placebo in patients with CAD.Secondary objectives:- To demonstrate the effect of pegcetacoplan on the number of PRBC…