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Набира участници Фаза 1

A Phase I study to evaluate the safety and efficacy of L19IL2 in combination with ruxolitinib in patients with advanced solid tumors.

Advanced solid tumors specifically: • metastatic clear cell renal carcinoma • proficient mismatch repair / microsatellite stable (pMMR/MSS) BRAF-V600E-mutant negative colorectal carcinoma • locally advanced or metastatic pancreatic adenocarcinoma

Trial status: Authorised

Начало: 22.12.2025 Възраст: от 18 г.

Italy Philogen S.p.A. 2025-522243-17-00

Набира участници Фаза 3

A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Lewy body Dementia psychosis (LBDP)

Trial status: Authorised Treatment-emergent adverse events (TEAEs)

Начало: 03.11.2025 Възраст: от 18 г.

Bulgaria, Czech Republic, France +1 Acadia Pharmaceuticals Inc. 2025-521711-39-00

Набира участници Фаза 3

CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)

Agitation Associated with Alzheimer’s Disease

Trial status: Authorised Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths, AEs of special interest, Assessment of abnormal involuntary movements or restlessness, Body weight, Blood pressure and heart rate, Laboratory evaluations, Suicidal ideation, Assessment of cognition, Assessment of urinary retention. Incidence of any Treatment-Emergent Adverse Events (TEAEs).

Начало: 21.10.2025 Възраст: от 18 г.

Bulgaria, Croatia, Czech Republic +8 Bristol-Myers Squibb Services Unlimited Company 2024-519994-20-00

Набира участници Фаза 2

A Phase II Open-Label Pilot Trial Assessing the Safety of Anifrolumab in Adult Patients with Primary Antiphospholipid Syndrome (APS). The AnifAPS trial.

Primary Antiphospholipid Syndrome (APS)

Trial status: Authorised Change from baseline (neutralization rate) in type I IFN signature, as assessed by a validated 4-gene panel at weeks 24 and 52, Change from baseline in aCL and aβ2GPI IgG antibody titres and LA status at weeks 12, 24 and 52, Change from baseline in lupus anticoagulant (LA) status at weeks 24 and 52, Change from baseline in complement C3 and C4 levels at weeks 12, 24 and 52, Change from baseline in endogenous thrombin potential, as assessed by a thrombin generation assay at weeks 24 and 52, Change from baseline in the levels of ΝET release markers [i.e., myeloperoxidase (MPO), citrullinated histone H3 (H3Cit) and MPO-deoxyribonucleic acid (DNA) complexes), as assessed by immunofluorescence confocal microscopy and enzyme-linked immunosorbent assay (ELISA) at weeks 24 and 52, Change from baseline in immunothrombosis/thromboinflammation-related gene expression, as assessed by bulk ribonucleic acid (RNA) sequencing at weeks 24 and 52, Change from baseline in the 36-Item Short Form Survey version 2 (SF-36v2) score at weeks 4, 12, 24, 36, 48 and 52, Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at weeks 4, 12, 24, 36, 48 and 52, Change from baseline in the Patient Health Questionnaire 9 (PHQ-9) score at weeks 4, 12, 24, 36,.48 and 52, Change from baseline in the Patient’s Global Assessment of health status (PtGA) score at weeks 4, 12, 24, 36, 48 and 52, Change from baseline in the Physician’s Global Assessment of patient’s health status (PhGA) score at weeks 4, 12, 24, 36, 48 and 52, Rate of recurrent venous or arterial thrombotic events within patients with thrombotic APS by week 52, Proportion of patients with livedoid vasculopathy/skin ulcers at baseline achieving CR defined as skin ulcer complete closure as assessed by physical examination, PR defined as ≥50% improvement (wound area reduction) in skin ulcers, and NR defined as no change or worsening of skin ulcers by week 52, Proportion of patients with aPL nephropathy at baseline achieving complete response (CR) defined as proteinuria

Начало: 21.10.2025 Възраст: 18–64 г.

Greece National And Kapodistrian University Of Athens 2025-520918-64-00

Набира участници Фаза 3

B7981028 - A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Alopecia areata

Trial status: Authorised • Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 at all visits. • Response based on achieving absolute SALT score ≤20 at all visits • Change from baseline (CFB) in SALT score at all visits. • Response based on achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score at all visits in participants with an abnormal EBA at baseline., • Response based on achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score at all visits in participants with an abnormal ELA at baseline. • Patient Global Impression of Change (PGI-C) response defined as score of “moderately improved or greatly improved” at all time points., • CFB in Patient Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score at all visits. • CFB in PROMIS Parent Proxy Anxiety Symptoms T-score at all visits., • CFB in Behavior Rating Inventory of Executive Function®2 (BRIEF®2) T-scores for the three index scores (Behavior Regulation Index [BRI], Emotional Regulation Index [ERI], Cognitive Regulation Index [CRI]) at all visits., • CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score at all visits. • CFB# in Wechsler Intelligence Scale for Children® Fifth Edition (WISC-V) at end of study (Month 36). • Incidence of treatment-emergent adverse events (AEs). • Incidence of serious AEs (SAEs) and AEs leading to permanent discontinuation from the study.

Начало: 14.10.2025

Czech Republic, France, Italy +2 Pfizer Inc. 2024-515439-31-00

Набира участници Фаза 2

A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis

Non-cystic Fibrosis Bronchiectasis

Trial status: Authorised Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs TTF (Time to first) Exacerbation

Начало: 26.09.2025 Възраст: от 18 г.

Belgium, Denmark, France +7 CSL Behring LLC 2024-518821-13-00

Набира участници Фаза 2

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects with Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC)

Low-grade upper track urothelial carcinoma (LG-UTUC)

Trial status: Authorised Primary Safety Endpoint: The number of treatment-emergent adverse events reported by each subject during the trial., Primary Efficacy Endpoint: Complete response at 3 or 6 months defined as absence of any UTUC in the renal pelvis, i.e. negative urine cytology for high-grade urothelial carcinoma (centrally assessed), and either no suspicious lesions on ureteroscopy (investigator assessed) or a negative for-cause biopsy (centrally assessed)

Начало: 16.09.2025 Възраст: от 18 г.

France, Netherlands, Spain Ferring Pharmaceuticals A/S 2024-514360-70-00

Набира участници Фаза 1

A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma – NEO-CYT

High-Risk Surgically Resectable Melanoma

Trial status: Authorised

Начало: 15.09.2025 Възраст: от 18 г.

Italy Fondazione Melanoma Onlus 2024-519010-31-00

Набира участници Фаза 3

A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial

Atherosclerotic cardiovascular disease (ASCVD)

Trial status: Authorised Time to the first occurrence of 4P-MACE from parent study baseline, Time to the first occurrence of 4P-MACE from OLE study baseline, Cumulative number of 4P-MACE over time from parent study baseline, Cumulative number of 4P-MACE over time from OLE study baseline, Observed value and change in Lp(a) from the parent study baseline, Observed value and change in Lp(a) from the OLE study baseline ● Occurrence of the followings: • Treatment Emergent Adverse Events (TEAEs) • Treatment Emergent Serious Adverse Events (TESAEs) • Treatment discontinuations due to TEAEs/TESAEs, ● TEAEs of special interest Observed value or change/shift from baseline in: • Safety laboratory measures • Vital signs

Начало: 18.08.2025 Възраст: от 18 г.

Austria, Belgium, Bulgaria +17 Novartis Pharma AG 2024-519870-38-00

Набира участници Фаза 1

A phase I study of [68Ga]Ga-DWJ155 in patients with advanced breast and NSCLC cancers

Advanced breast cancer and advanced NSCLC

Trial status: Authorised

Начало: 03.07.2025 Възраст: от 18 г.

Netherlands Novartis Pharma AG 2024-517746-34-00

Набира участници Фаза 3

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer’s Disease

Dominantly Inherited Alzheimer’s Disease (DIAD)

Trial status: Authorised Stage 1 and Stage 2: • Incidence and severity of TEAEs, o serious TEAEs, o serious drug related TEAEs, o TEAEs leading to discontinuation, o TEAEs resulting in death • ARIA noted by MRI • laboratory parameters • vital signs • ECGs (if done), Biomarker interim analyses may be used for dose-adjustment, remediation, or stopping a study drug arm for efficacy and/or futility. Biomarkers are specified for each drug based on mechanism of action and may include soluble biochemical measures (e.g., Aβ and tau), imaging measures of pathology (e.g., amyloid PET), and AD biomarker changes (e.g., atrophy measured by MRI, and neurodegeneration measured by NfL)., Remternetug arm specific Secondary end point Stage 1: Secondary efficacy endpoints include: • The proportion of participants who are amyloid positive (CL level ≥ 16.3) at the end of Stage 1, • Change in CSF pTau217/Tau217 ratio, • Change in CSF pTau231/Tau231 ratio, and • Change in CSF 3-repeat isoform of MTBR (MTBR-3R)., Remternetug arm specific Secondary end point Stage 2: Odds ratio between the treated group and the external control group (DIAN Obs and DIAN-TU-001 placebo) of being in the lower biomarker disease progression stage based on two-stage modeling of 6 biomarkers (CSF tau phosphorylated tau at residue 153 (pTau153)/Tau153 ratio, CSF pTau205/Tau205 ratio, CSF microtubule binding region of tau 243 amino acids long (MTBR-tau243), MRI hippocampal volume, CSF NfL, and MRI precuneus thickness)., Remternetug arm specific Secondary end point Stage 2: Other secondary endpoints for Stage 2 include: • Fluid and Imaging Biomarker Efficacy Endpoints o CSF pTau217/Tau217 ratio, CSF pTau231/Tau231, CSF MTBR-3R • Clinical and Cognitive Efficacy Endpoints o A cognitive composite derived as an average of these four tests: MAC-Q, Category Fluency (Animals), FCSRT-IR, WAIS-R Digit Symbol Substitution Test, and MMSE. o CDR-SB Stage 1: Defined in each drug-specific appendix; will be an assessment of biomarkers of early-stage disease (e.g., amyloid PET, soluble amyloid, soluble phospho-tau) compared with baseline in each treatment group, Stage 2: If applicable, will be defined in each drug-specific appendix, and will be an assessment of the change in progression of biomarkers representing tau, neurodegenerative, and inflammatory pathobiological events in the disease cascade for temporally different periods of the presymptomatic phases of the disease., Remternetug arm specific Primary end point Stage 1: The primary endpoint will only use data collected from Stage 1, and will be the change from baseline in brain Aβ plaque development as measured by centiloid (CL) [11C]-Pittsburgh compound B (PiB) PET.

Начало: 30.06.2025 Възраст: от 18 г.

France, Germany, Italy +2 Washington University School Of Medicine 2024-517187-36-01

Набира участници Фаза 2

The therapeutic potential of psilocybin in anorexia nervosa in young adults

Anorexia Nervosa

Trial status: Authorised General Anxiety (GAD-2), Patient Health Questionnaire (PHQ-2), Experiences in Close Relationships – (ECR–RS), Life Satisfaction (LS), Positive & Neg Affect (PANAS), Harmony in Life (HILS), Self-compassion (Short SCS), Ten Item Pers Inv (TIPI), AN symptom severity (EDE), Response: A clinically significant improvement in weight and psychological symptoms during the treatment period., Remission: The achievement and maintenance of weight restoration and psychological well-being, with no significant symptoms of anorexia nervosa., Relapse: Defined as a composite outcome during the 6-month follow-up period Incidence of adverse events (AEs) and serious adverse events (SAEs) during the trial period.

Начало: 18.06.2025 Възраст: 18–64 г.

Sweden Region Skane 2024-515163-63-00

Набира участници Фаза 3

An international, multicenter, randomized, double-blind, phase 3 pivotal registrational clinical study of APG-2575 (Lisaftoclax) combined with azacitidine in elderly patients with newly diagnosed acute myeloid leukemia (GLORA-3)

Acute myeloid leukemia

Trial status: Authorised Event-free survival (EFS): The interval from the date of randomization to the time point when any of the following “events” occur (whichever occurs first): • Progressive disease; • Disease recurrence after CR/CRi/CRh/MLFS; • Death of any cause (including but not limited to death caused by leukemia or therapeutic drugs); • CR/CRi/CRh/MLFS is not achieved after at least 6 treatment cycles., Complete response (CR) rate: The proportion of patients with complete response in the total analysis population., Overall response rate (ORR): The proportion of patients who have achieved CR, CRi, CRh, MLFS and PR in total analysis population., Composite complete response (CRc) rate: The proportion of patients who have achieved CR, CRi and CRh in total analysis population., Time to response (TTR): The interval from the date of randomization to the date of the first CR, CRi, or CRh., Duration of response (DOR): The interval from the date of confirming response (CR/CRi/CRh) to the date of disease recurrence or death of any cause (whichever occurs first). DOR will be calculated for patients with the best response of CR, CRh and CRi separately., Safety and tolerability of subjects: Treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated., Population pharmacokinetic (Pop PK) parameters of APG-2575., Results of EORTC QLQ C30 (V3) and EuroQol 5-Dimension (EQ-5D) questionnaire. Overall survival (OS): Interval between the date of randomization to the date of death of any cause. Survival time will be censored at the latest known survival date of the subject if death cannot be confirmed.

Начало: 05.05.2025 Възраст: от 18 г.

Italy, Poland, Spain Ascentage Pharma Group Inc. 2024-516436-10-00

Набира участници Фаза 2

An open-label extension study evaluating the safety of zagociguat in participants with MELAS who completed TIS6463-203

Mitochondrial encephalomyopathy lactic acidosis and stroke-like episodes (MELAS)

Trial status: Authorised Vital sign measurements, ECG assessments, clinical laboratory tests, and C-SSRS responses at each scheduled timepoint, DEXA hip and lumbar spine BMD at each scheduled timepoint, Concentrations of CTX and P1NP at each scheduled timepoint, Incidence of SLE. Time to first SLE from Day 1, NMDAS scores at each scheduled timepoint, Concentrations of lactate, GDF-15, FGF-21, B2M, serum amyloid P component, TNFR-2, vWF, ICAM-1, NfL, and VCAM-1 at each scheduled timepoint, CGI-C overall MELAS scale score at each scheduled timepoint, eGFR and UACR at each scheduled timepoint, HbA1c level at each scheduled timepoint, Concentrations of troponin I, NT-proBNP, and creatine kinase (CK)-MB at each scheduled timepoint, Exploratory pharmacokinetics: Concentrations of zagociguat at each scheduled time point Incidence of treatment-emergent adverse events (TEAEs)

Начало: 16.04.2025 Възраст: от 18 г.

Germany, Italy Tisento Therapeutics Inc. 2024-517514-15-00

Набира участници Фаза 2

Scar Remodeling after Burn Injury using Adipose-derived Allogeneic Stem Cells (ScarASC)

Hypertrophic scarring.

Trial status: Authorised Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0., Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter., Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter., Changes in collagen fiber arrangement., Up- and/or downregulation of biomarkers from punch biopsies., Development of de novo HLA., Histologic assessment of the presence of donor stem cells / DNA., Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up. Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0.

Начало: 11.04.2025 Възраст: от 18 г.

Denmark Copenhagen University Hospital 2024-519160-41-00

Набира участници Фаза 2

efficacy and safety of the use of regulatory T cells in immune hyperactivation in patients with COVID-19 and/or acute respiratory distress syndrome

immune hyperactivation in COVID-19 patients and/or acute respiratory distress syndrome

Trial status: Authorised

Начало: 30.01.2025 Възраст: 18–64 г.

Spain Fundacion Para La Investigacion Biomedica Del Hospital 2024-519799-25-00

Набира участници Фаза 2

Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM): A nationwide phase 2 trial of patients with smoldering and active multiple myeloma (MM)

Multiple Myeloma

Trial status: Authorised Clinical response by IMWG, Clinical outcomes by IMWG, Safety, Correlation with correlative and clinical outcomes Primary: Proportion of participants diagnosed with intermediate or high risk SMM that have MRD negativity three year from study enrollment

Начало: 11.12.2024 Възраст: 18–64 г.

IC Landspitali 2024-519353-11-00

Набира участници Фаза 4

Prospective evaluation of potential effects of repeated gadolinium-based contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group—ODYSSEY

Long term potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group effects regarding.

Trial status: Authorised Changes from baseline in the composite endpoint (Years 1 to 4) and in each individual test of motor and cognitive function (Years 1 to 5) will be assessed., Evaluation of AEs. The recording of AEs that occur after signing of the informed consent form (ICF) at Screening, will be done at baseline and at each annual visit. Signs/symptoms, onset date/time, severity, causality, seriousness, treatment and outcome will be recorded., Total gadolinium concentrations in blood plasma and urine samples collected at baseline and at each annual visit will be determined. If the CE-MRI is obtained at the same visit, the blood and urine samples will be obtained prior to imaging. The co-primary endpoints are the change from baseline to Year 5 in motor function and in cognitive function as expressed by the composite z score, defined as the weighted sum of the z scores of the individual tests. Since each of these tests is considered equally important, each test will be assigned an equal weight.

Начало: 27.11.2024 Възраст: 18–64 г.

France, Germany, Italy Iqvia Rds France 2024-515462-14-00

Набира участници Фаза 3

One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load.

Metastatic hormone-sensitive prostate cancer with high tumor load

Trial status: Authorised Time to PSA progression., Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bones)., Time to the start of the next anti-prostate cancer treatment., ORR, Safety endpoint. rPFS,OS

Начало: 26.11.2024 Възраст: от 18 г.

Bulgaria, Czech Republic, Poland Jiangsu Hengrui Pharmaceuticals Co. Ltd. 2024-515194-10-00

Набира участници Фаза 3

Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo)

Invasive Breast Cancer

Trial status: Authorised Pathological Complete Response (pCR), Relationship between pCR and EFS, Clinical Overall Response (cOR) at the end of neo-adjuvant treatment, Disease-Free Survival (DFS), Distant Event Free Survival, Overall Survival Event Free Survival (EFS)

Начало: 21.11.2024 Възраст: от 18 г.

Austria, Belgium, Germany +3 Fondazione Michelangelo 2024-518026-32-00

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