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Safety and protective efficacy of BCG vaccination against controlled human malaria infection

The primary objective is to determine the safety and tolerability BCG vaccination followed by controlled human malaria infection; and to determine the protective efficacy BCG vaccination against a controlled human malaria infection.

Human intestinal ischemia and reperfusion

This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)

To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

The primary objective of the study is to evaluate the reduction of low density lipoprotein cholesterol (LDL-C) by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (heterozygous familial…

An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

The objectives of this study are to:• Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects• Evaluate pharmacokinetics of imlifidase• Evaluate pharmacodynamics profile of imlifidase• Evaluate…

Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients

The primary objective of this study (MAP4B-safety) is to assess the safety of the application of the therapeutic product Alkaline Phosphatase (AP) in severely burned patients admitted to the intensive care unit. Secondary objectives are to assess…

iPAVE - imaging Pituitary ActiVation by Exendin

The study objective is to compare the pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss or classification by the treating diabetologist) to GLP-1R agonist treatment, to increase…

An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…

A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded, study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75% topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

Primary Objective* To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis Secondary Objectives* To explore skin and faecal microbiome in patients with seborrheic dermatitis * To evaluate the…

Comparison of the beta cell mass during and shortly after the honeymoon phase of type 1 diabetes using Ga-68-exendin PET

The study objective is to measure beta cell mass and function in subjects with type 1 diabetes during and shortly after the honeymoon phase, to determine whether the change in metabolic control is mainly caused by a decrease in the total number of…

Neuroinflammation and post-infectious fatigue in individuals with and without Covid-19

The aim of this study is to quantify neuroinflammation and whole-body inflammation with [18F]DPA-714 PET scans in post-COVID-19 patients and relate it to cognitive, psychiatric and post-infectious fatigue symptoms.

A First in Human trial to study safety and tolerability of single rising intravitreal doses (oPen label, non-randomized, uncontrolled) and in Addition the early biological Response of mulTiple intravitreal doses (double-masked, RandomIzed, shamcontrolleD) of BI 765128 in panretinal photocoaGulation (PRP) treated diabetic rEtinopathy (DR) patients with diabetic macular ischemia (DMI) - the PARTRIDGE Study

Diabetic Macular Ischemia (DMI) is a complication of diabetic retinopathy (DR) and can lead to vision loss. Currently, there are no approved or effective treatments to prevent either onset or progression of DMI in DR patients.As a transition from…

A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura.

The purpose of this study is to investigate how safe the new compound M254 is and how well it is tolerated when it is administered to healthy volunteers and patients with immune thrombocytopenia (ITP). M254 has not been administered to humans before…

A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients with Specific Gene Variants in the Melanocortin-4 Receptor Pathway

Primary:• To evaluate the proportion of patients with obesity with genetic variants in a specific gene in the melanocortin-4 receptor (MC4R) pathway who achieve a clinically meaningful reduction in body weight in response to setmelanotide at the end…

Study on the effects of an OCT2/MATE1 substrate (metformin) and inhibitor (cimetidine) on the exposure of trifluridine/tipiracil (Lonsurf®) in patients with metastatic cancer.

To determine the influence of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.

An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL C (ORION-3)

Primary:• To evaluate the effect of inclisiran treatment on low density lipoprotein cholesterol (LDL-C) levels at Day 210 compared to Day 1 of this extension study. Secondary:• To evaluate the effects of inclisiran on the following: LDL-C levels…