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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING)

This study has been transitioned to CTIS with ID 2023-504277-20-00 check the CTIS register for the current data. The aim of this global Phase III study is to investigate the use of tezepelumab as a treatment for patients with EoE. This study will…

A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II

This study has been transitioned to CTIS with ID 2024-510990-21-00 check the CTIS register for the current data. The co-primary objectives are: To evaluate the CNS activity of DNL310 vs idursulfase as measured by the cerebrospinal fluid (CSF)…

Randomised, open-label and parallel group trial to investigate the effects of oral BI 685509 alone or in combination with empagliflozin on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis.

The trial will investigate the safety and tolerability of BI 685509 in patients with CSPH in compensated cirrhosis due to HBV, HCV and NASH with or without T2DM and the combination of BI 685509 and empagliflozin in patients with CSPH in compensated…

The effect of 12-week supplementation with olive leaf extract (OLE) on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women (45-70 y); a randomized controlled trial.

The aim of this study is to investigate the effect of 12-week of 250 mg/day of olive leaf extract (OLE) supplementation on body composition and muscle strength, skin-aging and menopause-related quality of life in post-menopausal women (45-70 y).

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS)

This study has been transitioned to CTIS with ID 2024-514082-19-00 check the CTIS register for the current data. The aim of this phase 2 study is to investigate the safety and efficacy of dazucorilant in the target ALS patient population.

A single dose, randomised, double-blind 3-arm parallel-group study to compare the pharmacokinetics and α4β7 receptor saturation, for PB016 versus US-licensed and EU-approved Entyvio® after intraveneous administration in healthy subjects

The sponsor is developing a compound (PB016) similar to Entyvio® (vedolizumab, hereafter referred to as Entyvio). As part of medical-scientific studies to confirm the similarity of the biological products, the sponsor wants to compare PB016 with EU-…

A randomized, blinded, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of EGT710 following administration of single and multiple doses to healthy adults.

The purpose of the study is to see if the study compound (EGT710) is safe and tolerated when given to healthy adults. The study will also look at how the body absorbs, breaks down, and gets rid of the study treatment.Approximately 100 healthy…

A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Nonalcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)

1. Primary Objective The primary objective of this study is to assess the effect of lanifibranor alone compared toplacebo and the effect of lanifibranor in combination with empagliflozin compared to placeboon HbA1c after a 24-week treatment duration…

A multi-center, randomized, double-blind, parallel-group, 20-week dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with resistant hypertension

To evaluate the efficacy and dose-response relationship of XXB750 30 mg SC q4w, 60 mg SC q4w, 120 mg SC q4w, and 240 mg SC q4w compared to placebo in reducing the mean 24hr ambulatory systolic blood pressure (mean 24hr SBP) from baseline to Week 12.…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19

To evaluate the efficacy of BEM compared with placebo in reducing all cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care.

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

This study has been transitioned to CTIS with ID 2023-508645-40-00 check the CTIS register for the current data. Parts A and B:To evaluate the efficacy of efgartigimod PH20 SC on achieving sustained remission in the treatment of participants with…

A Four-Part, Open Label, Randomized, Parallel Assignment Study to Evaluate the Pharmacodynamics of Nirogacestat on B-Cell Maturation Antigen (BCMA)

Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…

Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (<= 45%) After Myocardial Infarction (HF-REVERT)

This study has been transitioned to CTIS with ID 2023-507569-24-00 check the CTIS register for the current data. This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess theefficacy and safety of CDR132L in…

A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

This study has been transitioned to CTIS with ID 2023-503794-38-00 check the CTIS register for the current data. - To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic…

A randomized, double-blind, international multicenter, phase III study to evaluate the anti-tumor efficacy and safety of HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) or placebo in combination with chemotherapy (carboplatin/cisplatin-etoposide) and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC)

This study has been transitioned to CTIS with ID 2024-515047-31-00 check the CTIS register for the current data. Primary objective:- To evaluate the anti-tumor efficacy of HLX10 in combination with chemotherapy and concurrent radiotherapy in…

Potential of FX06 to prevent disease progression in hospitalised nonintubated COVID-19 patients (Ixion)

The primary objective is to demonstrate a difference in the proportion of patients with progressed/worsened disease state in patients receiving FX06 compared to patients receiving placebo until day 28.Assessment and treatment comparison of the…

Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid

To evaluate the efficacy of two doses of norucholic acid vs. placebo for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to ursodeoxycholic acid (UDCA).

Trial NL80852.028.22

Publication withdrawn by sponsor

Bovine Osteopontin for Elderly Immune Support

Assess the percentage of responders to hepatitis B vaccination (i.e. attaining anti-hepatitis B antibody titres beyond 10 IU/L) in healthy elderly receiving a daily dose of OPN-10, compared to a placebo product.Secondary objectives:• Compare the…

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

This study has been transitioned to CTIS with ID 2024-512803-37-00 check the CTIS register for the current data. 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…