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Набира участници Фаза 3

The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol – SPHERE

respiratory arrest threatened airways tachycardia bradypnea +5

Trial status: Authorised How to calculate DAH30 (days alive and out-of-hospital at day 30): Has patient died in hospital or after discharge on any day within the first 30-days after randomization? If YES we will give 0 points Is the patient discharged from hospital on Day 5 after randomization but is subsequently readmitted for 5-days before their second hospital discharge? If YES we will give 20 points Is patient in a post- discharge nursing facility? If YES: we won’t consider as days at home.

Начало: 18.11.2024 Възраст: от 18 г.

Italy Ospedale San Raffaele S.r.l. 2024-518474-14-00

Набира участници Фаза 1

Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable high grade gliomas patients

Glioblastoma

Trial status: Authorised

Начало: 08.11.2024 Възраст: от 18 г.

France Centre Francois Baclesse 2024-514144-85-02

Набира участници Фаза 2

Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration (ReSCInD)

Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration

Trial status: Authorised All secondary endpoints are analyzed descriptively, and differences between the two study arms are explored according to their level of measurement. The primary endpoint, IL-1 β concentration in the blood within 24±6 hrs after symptom onset, will be analyzed in the full analysis set, which comes as close as possible to the IIT principle. A mixed linear regression model is calculated with the IL-1 β value (at 24±6hrs & 3 d) as the dependent variable, the randomized group, the IL-1 β value at baseline & the time point, the interaction of time + group, as independent variables and the patient as a random effect.

Начало: 31.10.2024 Възраст: от 18 г.

Germany Klinikum der Universitaet Muenchen AöR 2024-516701-22-00

Набира участници Фаза 2

EORTC-1525-LCG: Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)

type B3 thymoma and thymic carcinoma

Trial status: Authorised Progression Free Survival Rate at 6 months (PFSR-6) according to RECIST 1.1 per local investigator assessment, Safety according to CTCAE v4.0, Overall Response Rate (ORR) according to RECIST 1.1 per local investigator assessment, Disease Control Rate according to RECIST 1.1 per local investigator assessment (DCR), Duration of response according to RECIST 1.1 per local investigator assessment, Progression Free Survival (PFS) according to RECIST 1.1 per local investigator assessment, Overall Survival (OS), Progression Free Survival for patients continuing treatment after progression Progression Free Survival Rate at 6 months (PFSR-6) per independent radiological review

Начало: 20.08.2024 Възраст: от 18 г.

Belgium, France, Netherlands +1 European Organisation For Research And Treatment Of Can 2023-508658-24-00

Набира участници Фаза 2

VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2

Uncontrolled arterial hypertension

Trial status: Authorised 8 week change in peripheral and central arterial pressures and arterial stiffness, 8-week change in local concentrations of NO, EETs and ET-1 with sustained increase in blood flow, Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m) 8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow

Начало: 19.08.2024 Възраст: от 18 г.

France Centre Hospitalier Universitaire Rouen 2024-515928-36-00

Набира участници Фаза 2

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors

Metastatic solid tumors Advanced solid tumors

Trial status: Authorised Part B2: Incidence and severity of Adverse events (CTCAE v5.0), Best overall response (BOR), Objective Response Rate (ORR), Disease control rate (DCR), Duration of response (DOR) and change in tumor size, Serological tumor markers, Part A: Progression free survival (PFS), Overall survival (OS), ART6043 and ART7276 plasma concentration data, Olaparib plasma concentration data, Archival tumor or pre-dose tumor biopsy Part A: Incidence of Dose Limiting Toxicities (DLTs); incidence and severity of Adverse Events (CTCAE v5.0), Part B2: Progression free survival (PFS) (based on RECIST v1.1)

Начало: 19.07.2024 Възраст: от 18 г.

Spain Artios Pharma Limited 2023-509220-17-00

Набира участници Фаза 3

Evaluation of the efficacy and safety of stiripentol in patients 6 years and older with primary hyperoxaluria type 1, 2 or 3

Primary Hyperoxaluria (PH) of all subtypes (PH1 PH2 and PH3)

Trial status: Authorised Percent change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) from baseline to Month 3, Absolute change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) from baseline to Month 3 and Month 6, Change in 24-hour urine oxalate/creatinine ratio from baseline to Month 3 and Month 6, Proportion of patients with near normalisation of 24-hour urinary oxalate level corrected for BSA (defined as urinary oxalate lower than 1.5 x upper limit of normal (ULN)) at Month 3 and Month 6, Proportion of patients with normalisation of 24-hour urinary oxalate level corrected for BSA at Month 3 and Month 6, Change in estimated glomerular filtration rate (eGFR) from baseline to Month 6, Occurrence and frequency of kidney stone events during the follow-up, Change in urine oxalate/creatinine ratios as assessed in spot urine collections between baseline and Month 6, Change in biological parameters related to kidney stone formation between baseline and Month 6, Absolute change in the Pediatric Quality of Life Inventory (PedsQL [the generic and kidney failure (KF) modules]) for patients < 18 years of age (at screening) or in the Kidney Disease Quality of Life Questionnaire (KDQOL) for patients ≥ 18 years of age (at screening), Change in Euro Quality of Life Health State Profile Questionnaire (EQ-5D) and EQ-5D Visual Analog Scale (VAS) Percent change in 24-hour urinary oxalate excretion corrected for body surface area (BSA) from baseline to Month 6

Начало: 16.05.2024 Възраст: от 18 г.

Belgium, France, Italy Biocodex 2023-508062-15-00

Набира участници Фаза 4

The PHENOSAR trial: Antibiotic treatment of biopsy confirmed phenotypes in sarcoidosis: a proof of concept clinical trial.

sarcoidosis

Trial status: Authorised Reduction of sarcoidosis related inflammation.

Начало: 13.05.2024 Възраст: от 18 г.

Netherlands Sint Antonius Ziekenhuis Stichting 2024-513534-38-00

Набира участници Фаза 1

A Phase 1, multicenter, open-label study of REM-422, a MYB mRNA degrader, in patients with recurrent or metastatic, adenoid cystic carcinoma.

Adenoid cystic carcinoma (ACC)

Trial status: Authorised

Начало: 06.05.2024 Възраст: от 18 г.

France Remix Therapeutics Inc. 2023-508476-11-00

Предстои набиране Фаза 1

A Phase I, Open-Label Study of CLN-978 in Patients with Treatment-Refractory Rheumatoid Arthritis (RA)

Treatment-Refractory Rheumatoid Arthritis

Trial status: Under evaluation

Начало: 11.04.2025 Възраст: от 18 г.

Germany, Italy Cullinan Therapeutics Inc. 2024-519114-31-00

Активно (без набиране) Фаза 1

A trial comparing how the body absorbs and gets rid of petadeferitrin taken as two different forms in healthy people

Iron overload from thalassemia transfusion-dependent myelodysplastic syndromea and haemolysis

Trial status: Authorised

Начало: 07.04.2026 Възраст: 18–64 г.

Netherlands Pharmacosmos A/S 2025-525025-12-00

Активно (без набиране) Фаза 3

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 5)

Overweight or obesity and knee osteoarthritis

Trial status: Authorised CCI, CCI, Change in WOMAC physical function score, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in body weight, Change in body mass index (BMI), Change in WOMAC stiffness score, Change in WOMAC total score, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol and Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Use of allowed rescue analgesics during washout period (Yes/no), Amount of allowed rescue analgesics used during washout period, Use of pain medication (Yes/No), Amount of pain medication used, Change in pain medication (decrease/no change/increase), Change in knee pain intensity (NRS), Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation Relative change in body weight, Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

Начало: 07.04.2026 Възраст: от 18 г.

Bulgaria, Denmark, Greece +3 Novo Nordisk A/S 2024-520444-42-00

Активно (без набиране) Фаза 3

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 6)

Overweight or obesity and knee osteoarthritis

Trial status: Authorised CCI, CCI, Change in WOMAC physical function scorea, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in body weight, Change in body mass index (BMI), Change in WOMAC stiffness score, Change in WOMAC total score, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Use of allowed rescue analgesics during washout period (Yes/no), Amount of allowed rescue analgesics used during washout period, Use of pain medication (Yes/No), Amount of pain medication used, Change in pain medication (decrease/no change/increase), Change in knee pain intensity (NRS), Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation Relative change in body weight, Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

Начало: 07.04.2026 Възраст: от 18 г.

Bulgaria, Denmark, Greece +3 Novo Nordisk A/S 2024-520445-23-00

Активно (без набиране) Фаза 3

Open Label Extension (OLE), multiple dose study to evaluate pharmacokinetics, safety, tolerability and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with juvenile idiopathic arthritis (JIA).

Juvenile idiopathic arthritis

Trial status: Authorised Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time., Percentage of subjects with JIA ACR inactive disease., Percentage of subjects with JIA ACR clinical remission over time., Incidence of treatment-emergent uveitis (including severity)., Duration of response. Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.

Начало: 01.04.2026

France, Germany Alfasigma S.p.A. 2025-523239-21-00

Активно (без набиране) Фаза 2

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants with Moderate-to-Severe Hidradenitis Suppurativa

Moderate-to-Severe Hidradenitis Suppurativa

Trial status: Authorised Percentage of participants achieving skin pain numeric rating scale (NRS) 30 response at Week 16, meaning at least 30% and 2-point reduction in pain scores from baseline, for those with initial NRS scores of 3 or higher., Percentage of participants achieving HiSCR 50 at Week 16 (50% fewer inflamed skin bumps with no increase in abscesses or draining tunnels)., Percentage of participants achieving meaningful improvement in quality of life [Dermatology Life Quality Index (DLQI) reduction (improvement) of 4 or more points] at Week 16 among those with initial DLQI scores of 4 or higher., Percentage of participants experiencing a HS flare (worsening) at Week 16, defined as at least 25% increase in AN Count with an absolute increase of 2 or more compared to baseline., Change in disease severity (measured by the International Hidradenitis Suppurativa Severity Score System or IHS4) from baseline to Week 16., Change in AN count and the number of draining tunnels from baseline to Week 16., Number of participants with treatment-related side effects, serious side effects, and specific side effects of special concern. The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps [abscess and inflammatory nodule (AN) count ] with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study).

Начало: 25.03.2026 Възраст: от 18 г.

Bulgaria, Germany, Hungary +2 Navigator Medicines Inc. 2025-523557-33-00

Активно (без набиране) Фаза 2

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC)

Advanced non-small cell lung cancer (NSCLC)

Trial status: Authorised Overall survival (OS), Duration of response (DOR) and disease control rate (DCR) (assessed by the BICR and the investigator), Adverse events (AEs), serious adverse events (SAEs), laboratory tests, vital signs, 12-lead ECG, and physical examination, Blood drug concentration and pharmacokinetics parameters of HLX43 at different doses (ADC, total antibody, and free small molecule toxin), Positive rates of anti-HLX43 antibody (ADA) and neutralizing antibody (NAb), Potential predictive or drug resistance biomarkers, such as PD-L1 expression levels, tumor-related gene mutations or expression levels, serum proteomic profiles, Quality of life assessment, Objective response rate (ORR) (assessed by investigator as per RECIST v1.1), Progression-free survival (PFS) (assessed by the BICR and the investigator as per RECIST v1.1) Objective response rate (ORR) (assessed by the Blinded Independent Central Review [BICR] as per RECIST v1.1)

Начало: 25.03.2026 Възраст: от 18 г.

France, Italy, Poland +2 Shanghai Henlius Biotech Inc. 2025-523803-31-00

Активно (без набиране) Фаза 3

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02).

Biliary Tract Cancer

Trial status: Authorised Progression Free Survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy

Начало: 23.03.2026 Възраст: от 18 г.

Belgium, France, Germany +4 AstraZeneca AB 2025-523085-24-00

Активно (без набиране) Фаза 3

A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)

Nummular Dermatitis

Trial status: Authorised 1. Percentage of participants with Pruritus NRS ≥4 at baseline achieving a ≥4-point improvement in Pruritus NRS score from baseline at Week 24, 2. Absolute change from baseline in DLQI to Week 24. 1. Percentage of participants achieving endpoint reduction from baseline at Week 24.

Начало: 23.03.2026 Възраст: от 18 г.

Bulgaria, Germany, Italy +2 Almirall S.A. 2025-522403-17-00

Активно (без набиране) Фаза 2

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation

Endocrine-Resistant Hormone-Receptor-Positive HER2-Negative Advanced Breast Cancer with Chromosome 8p Loss and Without PIK3CA Mutation

Trial status: Authorised PFS, OS, Investigator-assessed DOR, Investigator-assessed CBR, Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), Change from baseline in targeted vital signs, Change from baseline in targeted clinical laboratory test results, Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities as assessed through use of the National Cancer Institute (NCI) Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument, Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side-effect bother single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General questionnaire (FACT-G), Change from baseline/worsening in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of the PRO-CTCAE and FACT-G GP5 item, respectively Investigator-Assessed Confirmed ORR

Начало: 23.03.2026 Възраст: от 18 г.

France, Germany, Italy +2 F. Hoffmann-La Roche AG 2025-523013-28-00

Активно (без набиране) Фаза 1

A study in healthy people to test how vicadrostat affects the heart

Healthy volunteer trial

Trial status: Authorised

Начало: 20.03.2026 Възраст: 18–64 г.

Germany Boehringer Ingelheim International GmbH 2025-524106-14-00

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