Search for a trial

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…

Testing an increased visit interval scHeme UsIng web-based Self-evaluation (THUIS-study)

Our objective is to safely increase the visit interval to 6 months in JIA patients with stable disease. The skipped 3-month visit isreplaced by a self-evaluation via e-mail by EQ-5D-5L-Y and JAMAR questionnaires that will be send via Castor EDC.…

Effectiveness and cost-utility of telemonitoring lab results and e-consultations in rheumatoïd artritis.

The primary objective of the JOINT Monitoring study is to assess the impact of telemonitoring on the effects, measured in PROMS, and the costs considering a societal perspective, in Rheumatoid Arthritis patients.

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…

An open-label, 8-week, proof of concept trial on thymosin-α1 (thymalfasin) in the treatment of primary antibody deficiency (PAD) associated mood disorders (TIDAM).

Based on the effects of Tα1 on immune cell function, the known disturbances in T lymphocyte numbers and subsets in patients with CVID and the increased prevalence of mood disorders in these patients the following research questions have been…

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 (…

A clinical study to investigate Interferon gamma (IFN*) signature in patients post HSCT and in patients with impaired HSC proliferation pre-transplant

HSCT cohort:* -To investigate the relationship between IFNγ levels and IFNγ activity by measuring CXCL9 levels and the risk of graft failure* -To investigate the relationship between IFNγ levels and IFNγ activity by measuring CXCL9 levels and the…

The role of gutmicrobiota composition, epigenetics and autoimmunity in the development and treatment of vasculitis; the VASKIR biobank

Primary Objective: Primary: Gut microbiota (oral and fecal) and nasal microbiota composition in relation to autoimmunity status (antibodies (ANA, ANCA) and HLA subtype) and inflammatory functional assays as well as disease&…

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 randomized controlled trial to investigate the (cost)effectiveness of oral immunotherapy with different allergens in young children with an established food allergy.

What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care?What is the effect of early low…

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…

Rac1/pSTAT3 expression: Towards a potential pharmacodynamic marker to optimize and individualize thiopurine therapy in IBD patients

The aim of this study is to explore intra-individual differences in expression of Rac1 and pSTAT3 in leucocytes of IBD patients before and during thiopurine treatment.

ANIfrolumab treatment for 24 weeks in patients with primary Sjögren*s syndrome - Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II)

This study has been transitioned to CTIS with ID 2024-516770-29-00 check the CTIS register for the current data. The objective of this study is to evaluate the clinical efficacy, biological effects and safety of anifrolumab treatment in pSS.

INflammation and cerebral small vessel disease (INSVD) study

To investigate the role of the immune and coagulation system on the progression of cerebral SVD

First-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of Apta-1.

Part ATo evaluate the safety and tolerability of single and split intravenous doses of Apta-1 in healthy volunteers.Part BTo evaluate the safety and tolerability of split intravenous doses of Apta-1 after LPS infusion in healthy volunteers.

A randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate safety, PK and the immunosuppressive effects of p38 MAPK inhibitor POLB 001 on the intradermal and intravenous LPS challenge response in healthy volunteers.

• To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers• To evaluate the effect of POLB 001 on inflammatory responses following an intravenous LPS challenge in healthy volunteers

Acute immunotoxicological effects of traffic-related micro- and nanoplastics in urban air.

The main objective is to study presence of MNPs in blood and short-term changes in blood leukocytes, inflammatory markers and the anti-oxidant defence system, in association with traffic-related microplastic exposure in healthy young adults.…

Clinical observational study on the relationship between digital and clinical parameters of fatigue and sleep in neurodegenerative disorders and immune-mediated inflammatory diseases

Identify and evaluate digital parameters of fatigue and sleep that reflect daily self-reported measures in a mixed disease patient population.

Clinical investigation of the safety of the MediSieve Magnetic Haemofiltration System in healthy volunteers.

To determine safety of the MediSieve Magnetic Hemofiltration System in healthy volunteers.