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A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/ PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

This study has been transitioned to CTIS with ID 2023-509743-27-00 check the CTIS register for the current data. x To assess the safety and tolerability of MK-7240/PRA023 in SSc-ILD x To compare the annual rate of change from Baseline in forced…

Evolut* EXPAND TAVR II Pivotal Trial

The purpose of this trial is to evaluate the safety and effectiveness of the Medtronic Evolut PRO+ and Evolut FX TAVR system and guideline-directed management and therapy (GDMT) compared to GDMT in patients with moderate, AS. Data will be used to…

Medication (de)prescribing in hospitalized geriatric patients with sarcopenia, less is more?

The effects of DPA compared to STOPP-START approach (SSA) prescribing on adverse drug reactions, medical complications, hospital readmission, quality of life in hospitalized geriatric patients with sarcopenia

Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients

This study has been transitioned to CTIS with ID 2023-509885-39-00 check the CTIS register for the current data. The primary objective is to describe and compare the incidence of hepatotoxicity in standard care and in a regimen with an optimized…

A randomized, double-blind, placebo-controlled, parallel-group, phase 2 study to evaluate the safety and efficacy of CT1812 in subjects with mild to moderate Alzheimer's disease

The purpose of this study is to evaluate the safety and efficacy of two doses of the study drug CT1812 per day for six months in subjects with mild to moderate Alzheimer's disease. CT1812 will be compared with a placebo. A placebo is a product…

Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis

This study has been transitioned to CTIS with ID 2023-510195-31-00 check the CTIS register for the current data. The study aim is to examine different doses of Naronapride film-coated tablets (for oral intake) versus placebo in patients with…

An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in
combination with pembrolizumab versus pembrolizumab alone in patients
with previously untreated, unresectable, or metastatic (advanced)
melanoma

This study has been transitioned to CTIS with ID 2024-511996-13-00 check the CTIS register for the current data. The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone…

The effects of a colon-delivered multivitamin supplement on brain functioning and its relation with immunometabolic and intestinal markers in ageing: the COMBI study

The primary objective of this study is to investigate the effect of a 6-week colon-delivered multivitamin supplementation on the gut-brain axis in older adults, by assessing changes in brain function (working memory) as well as intestinal changes (…

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

This study has been transitioned to CTIS with ID 2023-504869-23-00 check the CTIS register for the current data. 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30…

A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults >=60 years of age.

Primary objective:To demonstrate the non-inferiority (NI) of the humoral immune response in healthy participants 50-59 YOA compared to OA (>=60 YOA) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.To demonstrate…

Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients with Fibrodysplasia Ossificans Progressiva

This study has been transitioned to CTIS with ID 2023-508350-26-00 check the CTIS register for the current data. Primary ObjectiveThe primary efficacy objective of the study is to assess the effect of garetosmab (10 mg/kg) versus placebo on the…

A 26 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE FORMULATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE FORMULATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN SUBJECTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WI

Main Phase:To demonstrate the superiority of medium-dose BDP/FF/GB pMDI compared to high-dose BDP/FF pMDI in terms of the proportion of subjects exhibiting on average NPAL over 26 weeks of treatment in the study sub-population with PAL at screening…

A Phase 2, Randomized, Placebo-controlled, Parallel Group, Double-blind, Proof-of-concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren*s Syndrome

Primary:• To evaluate the effect of efgartigimod IV compared to placebo on CRESSSecondary:• To evaluate the effect of efgartigimod IV compared to placebo on the histology of the parotid gland (selected sites only)• To evaluate the safety of…

TAILOR-AHF: randomized controlled trial investigating a tailored diuretic algorithm in acute heart failure patients

Primary Objective: Investigate if a tailored diuretic algorithm based on Ur-Na has a positive effect on a composite endpoint of mortality, HF events (HFE) and a change in quality of life (QoL) (assessed with the Kansas city cardiomyopathy…

A Randomized, Blinded, Placebo-Controlled, Phase 1 Single Ascending Dose Study in Healthy Adult Male Volunteers and an Open-Label Multiple Ascending Dose Study in Pediatric SMA Participants Previously Treated with Onasemnogene Abeparvovec (Zolgensma*) to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115

This study has been transitioned to CTIS with ID 2023-505643-39-00 check the CTIS register for the current data. Part A: PrimaryTo evaluate the safety and tolerability of single ascending dose of BIIB115 administered via IT bolus injection to…

A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

This study has been transitioned to CTIS with ID 2023-505772-30-00 check the CTIS register for the current data. From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab…

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

This study has been transitioned to CTIS with ID 2023-503916-33-00 check the CTIS register for the current data. Primary Objective• Evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to standard immunochemotherapy…

Generation R Next intervention study

For this reason, we will conduct an intervention study aimed at promoting the health of (future) parents. The concrete goal of this intervention is to improve the health of (future) parents by optimizing lifestyle in the preconception period and…

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera

This study has been transitioned to CTIS with ID 2023-509750-58-00 check the CTIS register for the current data. In this study, we look at how safe the new medicinal product rusfertide is for the treatment of Polycythemia vera. And how well it works…

A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes

This study has been transitioned to CTIS with ID 2023-506981-30-00 check the CTIS register for the current data. Main objective:The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in…