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A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC
and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and
Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in
Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended
for Autologous Stem Cell Transplant as Initial Therapy

This study has been transitioned to CTIS with ID 2023-503442-30-00 check the CTIS register for the current data. The purpose of this study is to compare the efficacy of teclistamab and talquetamab both in combination with daratumumab and…

A Two-Part, Adaptive, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous and Intramuscular GM-2505 in Healthy Volunteers

To characterize the safety and tolerability of single intravenous (IV) doses (Part A) and intramuscular (IM) doses (Part B) of GM-2505 in healthy volunteers.

A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson*s disease

Primary:To evaluate the effects of pirepemat on falls frequency as compared to placebo.Secundary:To evaluate the effects of pirepemat on Parkinson's disease motor symptoms as compared to placebo.To evaluate the effects of pirepemat on apathy as…

A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

Primary objective:To evaluate the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP.Secondary Objectives:To evaluate the efficacy of depemokimab 100 mg SC + SoC compared to placebo…

The effect of ROSA-assisted knee arthroplasty on clinical outcomes

Primary Objective: to compare improvement in arthrosis symptoms between patients operated with ROSA-assistance and conventionally operated patients.Secondary Objective(s): to compare clinical, procedural, logistic and economic outcomes between…

Active Monitoring versus an Abduction Device for treatment of Infants with Centered Dysplastic Hips, a Comprehensive Cohort Study (TReatment with Active Monitoring (TRAM)-Trial)

The aim of this study is to compare treatment with an abduction device to active monitoring of infants with centered dysplastic hips (Graf type IIa- or IIb or IIc) during the first year of life.

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)…

Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial

To evaluate cost effectiviness of the SENS-U (continuous ultrasonic bladder monitoring) in urotherapy for children with functional daytime urinary incontinence.

Phase 1b/3 global, randomized, controlled, open-label trial comparing treatment with RYZ101 to standard of care (SoC) therapy in subjects with inoperable, advanced, somatostatin receptor expressing (SSTR+), well-differentiated gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy (ACTION-1)

This study has been transitioned to CTIS with ID 2023-509334-19-00 check the CTIS register for the current data. This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety,…

IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH).

The objective of the study is to establish an optimal dose of AV-101 based primarily upon the change in PVR but also other efficacy, safety, and tolerability findings from the Phase 2b Part of the study. The optimal dose will be taken into the Phase…

The effect of colchicine on Food-reLAted effort-based decision making in brain and behavIouR in overweight and obesity: the FLAIR-i study

Primary Objectives: • To study the causal role of inflammation in affecting food-related effort-based decision making in brain and behaviour in overweight and obese participants by employing a placebo-controlled intervention design with the anti-…

An intervention study on the effect of digital self-monitoring-based management of relapsing and remitting multiple sclerosis on self-efficacy, clinical outcomes and cost-effectiveness

To evaluate the effect of digital self-monitoring-based management of relapsing and remitting multiple sclerosis on self-efficacy, clinical outcome measures and cost-effectiveness

Difference in patellar tracking before and after Journey II BCS total knee arthroplasty, evaluated with 4D CT imaging

The current proposal aims to investigate the patellar tracking in patients receiving Journey II BCS total knee arthroplasty before and one year after surgery, positioned with the CORI instrumentation. The hypothesis is that less change in patella…

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS >=50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

This study has been transitioned to CTIS with ID 2023-507933-12-00 check the CTIS register for the current data. MAIN OBJECTIVES:- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by…

ACT your way: A transdiagnostic intervention for multiple disorders in transitional-age youth

The primary aim is to evaluate the effectiveness of ACT your way, by comparing ACT your way to treatment as usual (TAU) in TAY. The secondary aim is to evaluate the cost-effectiveness of ACT your way, by comparing ACT your way to TAU in TAY. The…

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF)

The aim of this study is to evaluate the efficacy, safety and tolerability of BI 1015550 9 mg BID and 18 mg BID compared to placebo in patients with IPF, in addition to the patient's standard of care. The primary objective of this study is to…

Trial Examining Methods for Antidepressant Discontinuation

This study has been transitioned to CTIS with ID 2024-511997-66-00 check the CTIS register for the current data. TEMPO will directly compare i) conventional 2-step reduction with ii) gradual tapering in patients with remitted MDD who use either the…

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…

Improving therapeutic ratio with hypofractionated stereotactic radiotherapy for brain metastases.

To determine if the incidence of adverse local events (local failure or radionecrosis) can be reduced with more than 20% using fSRT versus SRT in one or three fractions.

The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de novo Native Coronary Artery Lesions

To evaluate the safety, effectiveness and performance of the DESyne BDS Plus DECSS (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native…