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A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis

Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…

A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

PART A and PART DTo assess the safety and tolerability of TAK-994 following multiple oral doses in subjects with narcolepsy with or without cataplexy (NT1 or NT2).PART B and PART C To assess the efficacy of TAK-994 on reducing excessive daytime…

A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19

The study has the purpose and rationale to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID…

Randomised, double-blind (within dose groups), placebocontrolled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with diabetic kidney disease

The main objectives of the trial are to demonstrate the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with DKD by assessing 3 doses and placebo.

PERSONALIZED IMMUNOTHERAPY IN SEPSIS: A MULTICENTRE AND MULTINATIONAL, DOUBLE-BLIND, DOUBLE-DUMMY RANDOMIZED CLINICAL TRIAL

The aim of ImmunoSep is to study if personalized immunotherapy targeting either fulminant hyper-inflammation or immunoparalysis is able to improve sepsis outcomes.

Rescue Alkaline Phosphatase In Defense against all cause Acute Kidney Injury

To study the potential renoprotective effects of supplementation of alkaline phosphatase in hospitalized patients with AKI

RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19

• To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19• To show that ATR-002 in addition to standard of care shortens the time to…

Complement Inhibition: Attacking Overshooting inflammation @fter Subarachnoid Hemorrhage (CIAO@SAH trial)

This study has been transitioned to CTIS with ID 2025-520540-15-00 check the CTIS register for the current data. Primary Objective: To determine the safety and efficacy of 6000 IU C1-INH in patients with subarachnoid hemorrhage (SAH)Primary…

Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate or severe hidradenitis suppurativa.

The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…

A Phase 2, Randomized Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

To evaluate the effect of ISIS 696844 on the rate of change of the area of GA secondary to AMD measured by fundus autofluorescence (FAF)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)

To assess the safety, tolerability, and efficacy of ABBV-154 administered every other week (eow) and every 4 weeks (e4w) subcutaneously (SC) vs placebo in subjects with moderately to severely active RA with inadequate response to at least one prior…

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis

To evaluate the efficacy, safety, tolerability, in subjects with ALS following the oral administration of study drug (active or placebo capsules).

A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,
group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the
treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase…

Efficacy and feasibility of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial
(Ketamine Trial for Acute suicidality, KETA)

The aim of this study is to find a directly applicable intervention for acutely suicidal patients, so that the risk of these patients committing suicide is substantially lowered, leading to fewer actual suicides. To this end we propose a randomized…

A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of Nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion (NivoILP trial)

This study has been transitioned to CTIS with ID 2023-509265-21-00 check the CTIS register for the current data. To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further…

Boosting the endocannabinoid system before the treatment of anxiety symptoms

This study has been transitioned to CTIS with ID 2024-514783-78-00 check the CTIS register for the current data. The aim of this project is to investigate CBD as a new medicine to target the ECS in the reduction of anxiety symptoms. Subsidiary aims…

A Phase 2, randomized, double-blind, placebo-controlled, multicenter proof-of-concept study evaluating efficacy and safety of rilzabrutinib (SAR444671) in adult patients with moderate-to-severe atopic dermatitis who are inadequate responders or intolerant to topical corticosteroids

Primary objective:Assess the efficacy of rilzabrutinib in participants with atopic dermatitis (AD)Secondary objectives: * Assess the efficacy of rilzabrutinib at different time points* Assess the safety of rilzabrutinib

A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin
in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2

· To evaluate the effect of zibotentan anddapagliflozin in combination and alone versusplacebo on UACR.

Dose response and safety of an oral PCSK9i, NNC0385-0434, in patients with established atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction

Primary objective:To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients with Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

The primary objective of the study is to determine the proportion of patients with elevated TGs, without Familial ChylomicronemiaSyndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of…