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Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active
Ulcerative Colitis

The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…

Conditioning of insulin responses: a high rist- high gain intervention for diabetes type-2

The primary objective of this study is to investigate the effects of classical conditioning with intranasal insulin on endogenous insulin and glucose levels in diabetes type-2 patients and healthy controls. Additionally, we will examine the effects…

ILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study with an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1

Primary objective- To evaluate the effect of lumasiran on percent reduction in urinary oxalate excretion Secondary objectives - To characterize the effect of lumasiran on absolute levels of urinary oxalate excretion, oxalate:creatinine ratios, and…

A phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with early, oligoarticular psoriatic arthritis despite initial stable treatment with either non-steroidal anti-inflammatory drugs (NSAIDs) and/or <=1 conventional synthetic disease-modifying antirheumatic drugs (DMARD).

Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…

A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (Triple M trial)

This study will compare sequential mifepristone and misoprostol treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.

A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

To evaluate the effect of MEDI6012 on infarct size compared with placebo.

Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)

The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTcinterval in patients with stable CAD10 within the exposure range observed in Phase II/IIIstudies:Primary objective:* To investigate whether there is a…

A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.

US-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial

To study the effect of PNT and structured exercises on function and pain of patients with lateral elbow tendinopathy.

Efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children and adolescents aged from 7 to less…

Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

This exploratory study is designed to evaluate several depatuxizumab mafodotin-related OSE management strategies.The main objective of this trial is to estimate the percentage of subjects in each prophylactic treatment arm who require a change in…

Multi-center, blinded, randomized, PaRAllEl-group, Phase 3 study with aproCItentan in Subjects with Resistant HypertensiON (RHT)

The primary objective of the study is to demonstrate the BP lowering effect ofaprocitentan when added to standard-of-care in true resistant hypertension subjects.The secondary objectives of the study are• to demonstrate that the effect of…

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…

*CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept*

This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects with Multiple Osteochondromas

Primary Objective• To evaluate the efficacy of two dosage regimens of palovarotene compared with placebo in preventing new osteochondromas (OCs) in subjects with multiple osteochondromas (MO) due to exostosin 1 (Ext1) or exostosin 2 (Ext2) mutations…

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate
Mavacamten (MYK-461) in Adults with Symptomatic Obstructive
Hypertrophic Cardiomyopathy

Primary Objective* To compare the effect of a 30-week course of mavacamten with placebo on clinical response comprising of exercise capacity and clinical symptoms in participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn*s Disease (CARMEN CD 307)

Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…

A Randomized, Controlled, Double-blind Continuation Study Comparing the Long*term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis

Primary Objective* To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. Secondary Objectives* To assess the…