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Набира участници Фаза 1

An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogren’s Disease or Idiopathic Inflammatory Myopathy

Seropositive autoimmune disease: Sjogren’s disease or idiopathic inflammatory myopathy

Trial status: Authorised

Начало: 21.04.2026 Възраст: от 18 г.

Czech Republic Ouro Medicines Limited 2025-524100-29-00

Набира участници Фаза 2

Protocol Title: Efficacy and safety of once-weekly subcutaneous NNC0662-0419 in participants with type 2 diabetes – a dose-finding study

type 2 diabetes

Trial status: Authorised Relative change in body weight, Change in body weight Change in HbA1c

Начало: 21.04.2026 Възраст: 18–64 г.

Hungary, Poland, Portugal +1 Novo Nordisk A/S 2025-523260-20-00

Набира участници Фаза 2

NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial

Postmenopausal patients with small (pT1a-b pN0) hormone receptor positive (HR⁺) and HER2 negative (HER2⁻) early breast cancer with a Luminal A phenotype and at low risk of recurrence.

Trial status: Authorised RFI of participants treated with adjuvant hormone therapy in the CANTO study, Incidence of Ipsilateral DCIS, Contralateral DCIS, Invasive contralateral breast cancer at 5, 8 and 10 years*, Distant disease free survival (DDFS) and relapse free survival (RFS) rates at 5, 8, 10 years and overall survival (OS) at 5, 10 years * (RFI, DDFS, RFS and OS defined as per standardized STEEP v2.0 criteria), EORTC QLQC30 and EORTC QLQ-BR42, HADS questionnaires, Bone-related events and osteopenia/osteoporosis diagnosis, dyslipidemia (hypercholesterolemia and hypertriglyceridemia) and cardiovascular events (myocardial infarction, stroke, and thromboembolic events), as per CTCAE v6.0. Relapse-free interval (RFI) is defined as the delay between initial treatment and the first occurrence of i) ipsilateral breast tumor recurrence, ii) distant or locoregional recurrence or iii) death from breast cancer, according to the STEEP system definition version 2.0 (Tolaney SM et al., JCO 2021)

Начало: 21.04.2026 Възраст: от 18 г.

France Unicancer 2025-523683-20-00

Набира участници Фаза 3

A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia

Chemotherapy induced thrombocytopenia

Trial status: Authorised Proportion of participants who completed two consecutive on-study chemotherapy cycles without thrombocytopenia-induced modification of any myelosuppressive agent., Proportion of participants achieving PC ≥100×109 /L without the use of rescue therapy within 14 days after initiating the IP treatment (including Day 14), Proportion of participants with at least a single incidence of rescue therapy., Time to rescue therapy free first platelet response of PC ≥100×109/L defined as the interval between the initiation of IP treatment and the first platelet response., Cumulative duration of platelet response of PC ≥100×109/L without the use of rescue therapy., PC nadir from C1D1 until C2D21 (window period: +4 days)., Cumulative duration of severe thrombocytopenia, defined as the number of consecutive days with a PC of ≤50×109/L., Proportion of participants who completed two consecutive on-study chemotherapy cycles without treatment regimen modification., Proportion of participants with all cause events leading to treatment regimen modifications including dose reduction, delay, omission, or discontinuation., Proportion of participants who are free from serious bleeding events, defined as Grade >=2 per the World Health Organization (WHO) bleeding scale, during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Number and proportion of participants with adverse events (AEs)/serious adverse events (SAEs), safety laboratory parameters, vital signs, etc., Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Proportion of non-Asian treatment responders who meet the following criteria (Part A only): 1) Platelet count (PC) of 100×109/L within 14 days after initiating the IP treatment (incl. Day 14); 2) Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3) No use of any rescue therapy for thrombocytopenia during the treatment period from initiation of IMP treatment until Day 21 of C2 (C2D21; window period:+4d) Part A: PK parameters (e.g., Cmax, AUC0-tau, Cmin) of hetrombopag in non-Asian participants with CIT., Proportion of treatment responders meeting these criteria: 1. Platelet count (PC) ≥100×109 /L within 14 days after initiating IMP treatment (incl Day 14); 2. Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3. No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of IP treatment until Day 21 of C2 (C2D21; window period: +4 days).

Начало: 21.04.2026 Възраст: от 18 г.

France, Poland, Romania Jiangsu Hengrui Pharmaceuticals Co. Ltd. 2025-524209-34-00

Набира участници Фаза 3

A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension

Participants with Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Trial status: Authorised Change from baseline at Week 72 in the PSPRS-28, Changes from baseline at Week 72 in activities of daily living on the XXX, Change from baseline at Week 72 in the Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL), Change from baseline at Week 72 in the Category Fluency, Phonemic Fluency, Symbol Digit Modality Test (SDMT), and Letter-Number- Sequencing (LNS), Changes from baseline in volumes of ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, frontal lobe as measured by MRI until Week 72., Safety and tolerability parameters including AEs, AESIs, SAEs (including SAEs with fatal outcomes), AEs leading to XXX and treatment interruptions, AEs leading to dose discontinuation, clinical laboratory evaluations, vital signs, electrocardiogram (ECG), XXX Change from baseline at Week 72 in the rPSPRS-10 score

Начало: 21.04.2026 Възраст: от 18 г.

Belgium, Germany, Netherlands Novartis Pharma AG 2025-523481-24-00

Набира участници Фаза 2

A single-arm, open-label, multi-centre, phase I/II first-in-human study evaluating the safety and clinical activity of QEL-005, an autologous CAR T-regulatory cell therapy treatment targeting CD19, in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).

Diffuse cutaneous systemic sclerosis (dcSSc) Difficult to treat rheumatoid arthritis (D2TRA)

Trial status: Authorised Dose escalation part: Incidence of protocol-defined dose-limiting toxicities (DLTs) within 14 days postinfusion; Treatment-emergent SAEs, adverse events (AEs) and AEs of Special Interest (AESIs); Clinically significant changes in safety laboratory assessments, ECG and vital signs., Expansion part: Treatment-emergent serious adverse events (SAEs), adverse events (AEs) and AEs of Special Interest (AESIs); Clinically significant changes in safety laboratory assessments, electrocardiogram (ECG) and vital signs.

Начало: 21.04.2026 Възраст: от 18 г.

Germany, Spain Quell Therapeutics Limited 2025-523971-46-00

Набира участници Фаза 2

Albuminuria Reduction Trial and Investigation with Survodutide Treatment in CKD (ARTIST-CKD)

Chronic Kidney Disease

Trial status: Authorised Change from baseline to week 36 in eGFR (creatinine, cystatin C, and creatinine-cystatin C), Change from baseline to week 36 in Iohexol measured GFR (subset of 60 participants), Change in UACR and eGFR during 4-week wash-out from week 36 to 40, Change from baseline to week 36 in Perirenal and renal sinus fat measured by MRI (same subset of 60 participants with Iohexol GFR), Change from baseline to week 36 in Subcutaneous and visceral fat assessed by MRI (same subset of 60 participants with Iohexol GFR), Change from baseline to week 36 in Body weight, Change from baseline to week 36 in Waist circumference, Change from baseline to week 36 in Systolic and diastolic blood pressure Percentage change from baseline to week 32/36 in first morning void UACR

Начало: 21.04.2026 Възраст: от 18 г.

Germany, Netherlands Universitair Medisch Centrum Groningen 2025-525068-13-00

Набира участници Фаза 2

C6461008 - AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Trial status: Authorised Cohort A: - Duration of response (DoR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS), Cohort A: Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Cohort A: Predose and post dose concentrations of PF-08634404., Cohort A: Incidence of antidrug antibodies (ADA) against PF-08634404, Cohort B/C: - DoR using RECIST 1.1 as assessed by investigator - PFS using RECIST 1.1 as assessed by investigator - OS, Cohort B/C: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Cohort B/C: Predose and post dose concentrations of PF-08634404, Cohort B/C: Incidence of ADA against PF-08634404 Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator, Cohort A: Adverse events (AEs) as characterized by type, frequency, intensity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, timing, seriousness, and relationship to study intervention(s), Cohort B/C: Dose limiting toxicities (DLTs) in the first cycle (Part 1), Cohort B/C: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)., Cohort B/C: Confirmed ORR using RECIST 1.1 as assessed by investigator

Начало: 21.04.2026 Възраст: от 18 г.

Germany, Spain Pfizer Inc. 2025-523524-53-00

Набира участници Фаза 2

A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

Malignancies with Documented KRAS BRAF and Other Selected RAS/MAPK Mutations

Trial status: Authorised 1. Dose Escalation: PK parameters of S241656 and its metabolite S243796, including but not limited to Cmax, tmax, AUC, and t½, 2. Dose Escalation: Objective response Disease Control Clinical Benefit Duration of Response Time to response Progression free survival Overall survival, 3. Dose Escalation: Clinical efficacy parameters Safety and tolerability parameters PK including: Exposure-toxicity relationship, 4. Dose Expansion: Clinical Efficacy Parameters Safety and Tolerability Parameters PK & PD parameters, 5. Dose Expansion: Disease Control Clinical Benefit Duration of Response Time to Response Progression free survival Overall Survival, 6. Dose Expansion: PK parameters of S241656 and its metabolite S243796, but not limited to Cmax, tmax, AUC, and t½ Dose Escalation: Incidence of dose-limiting toxicities occurring within the first 28-day cycle Number of Adverse Events and Serious Adverse Events Dose Expansion: Objective response

Начало: 21.04.2026 Възраст: от 18 г.

Denmark, France, Italy Institut De Recherches Internationales Servier IRIS 2025-523474-16-00

Набира участници Фаза 2

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)

Homeostatic iron regulator gene-related hereditary hemochromatosis

Trial status: Authorised Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) ,

Начало: 20.04.2026 Възраст: от 18 г.

Belgium, Czech Republic, France +3 CSL Behring LLC 2025-523793-16-00

Набира участници Фаза 3

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)

Schizophrenia

Trial status: Authorised Change from baseline in Clinical Global Impression -Severity (CGI-S) score at Week 5 Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5

Начало: 20.04.2026

Romania Bristol-Myers Squibb Services Unlimited Company 2025-523711-11-00

Набира участници Фаза 1

A study to test how well different doses of BI 3820768 are tolerated by people with advanced cancer (solid tumours)

Advanced relapsed or refractory ovarian cancer Advanced relapsed or refractory endometrial cancer Advanced relapsed or refractory germ cell tumours

Trial status: Authorised

Начало: 20.04.2026 Възраст: от 18 г.

Belgium, France, Germany Boehringer Ingelheim International GmbH, Boehringer Ing 2025-522913-45-00

Набира участници Фаза 4

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ponatinib Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Iclusig (Ponatinib hydrochloride) tablets 15 mg, Produced by: Patheon Inc. Mississauga, Canada or Takeda Ireland Limited Bray, Ireland, Imported and registered by: Pint Pharma Medical-Hospital and Pharmaceutical Products Ltd. Nelson Pontes Street, 125, Block 03, Jardim Margar

chronic myeloid leukemia Philadelphia chromosome-positive acute lymphoblastic leukemia

Trial status: Authorised

Начало: 20.04.2026 Възраст: 18–64 г.

Romania Sun Pharmaceutical Industries Limited 2025-524311-37-00

Набира участници Фаза 4

Multiple-Dose Study in Healthy Participants Under Fasting Conditions to Evaluate the Bioequivalence of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide SR 1.5 mg and to Compare the Bioavailability of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide IR 2.5 mg.

No medical condition.

Trial status: Authorised

Начало: 20.04.2026 Възраст: 18–64 г.

Portugal Institut De Recherches Internationales Servier IRIS 2026-525823-26-00

Набира участници Фаза 4

CoCo-PCOS - Comprehensive Health Effects of Combined Contraceptives: a 6-month randomized, controlled, open-label trial of E4+DRSP, EE20µg+DRSP, and DRSP-only in women with PCOS

Contraception

Trial status: Authorised 6-month use of study preparation, endpoint visit

Начало: 20.04.2026 Възраст: 18–64 г.

Finland Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu 2025-523358-15-00

Набира участници Фаза 4

Impact of treatment with TransCon PTH on Quality of Life, cognitive function, brain structure, and cerebral capillary bloodflow in patients with hypoparathyroidism

Hypoparathyroidism

Trial status: Authorised Correlation between cognitive impairment measured by neuropsychological assessment and capillary transit time heterogeneity, cortical blood volume and hemodynamic parameters., Status of cognitive function in PTH treated compared to conventional treated controls, Difference in groups in size of structures in the brain. Difference in microvascular hemodynamic between PTH- and conventionally treated patients with chronic HypoPT

Начало: 20.04.2026 Възраст: от 18 г.

Denmark Region Midtjylland 2025-523930-14-00

Набира участници Фаза 3

KARMA - INtenSive care TreAtmeNT with adjuvant KetAmine and Recovery after Mechanical ventilAtion: a multicenter doubleblind randomized controlled trial

Adult patients admitted to the ICU and receiving unplanned invasive mechanical ventilation

Trial status: Authorised The number of days alive free of encephalopathy (coma or delirium measured on the CAM-ICU) during 14 days after randomization, The number of days spent alive without invasive mechanical ventilation (ventilation-free days) at 60 days;, The number of days spent alive without infusion norepinephrine or inotropes infusion during ICU stay (vasopressors-free days) at 60 days;, Mortality, defined by the prevalence of all-cause deaths at 60 and 90 days;, Toxicité rénale, définie par la proportion de patients atteignant un stade KDIGO ≥2 à 60 jours ;, Liver toxicity, defined by the highest bilirubin and phosphatase alkaline level during the first 60 days;, Quantification of opioid and sedative consumption during the treatment period, in each arm during the first 14 days., Mean daily pain (BPS) and sedation (RASS) scores, in each arm during the first 14 days, Cumulative incidence of hallucination events during 14 days after randomization, Presence of anxiety and depression, defined by a score ≥11 on the anxiety and depression components of the Hospital Anxiety and Depression scale, respectively at 90 days; (tertiary outcome), Acute posttraumatic stressdisorder (PTSD)-related (measured on the ICU memory tool) at 90 days. (tertiary outcome) The primary endpoint will be the number of days patients are alive and spent at home at 60 days after drug or placebo initiation. This endpoint will be collected by an independent research assistant, blinded to randomization groups and not involved in data monitoring onsite.

Начало: 20.04.2026 Възраст: от 18 г.

France Assistance Publique Hopitaux De Paris 2025-523149-80-00

Набира участници Фаза 3

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

treatment-naive Chronic Lymphocytic Leukemia

Trial status: Authorised • uMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ]), • PFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated), • OS, defined as time from the date of randomization to the date of death due to any cause, • ORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment, • uMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ), • Adverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs, • PFS determined by investigator assessment, • Overall CRR determined by IRC and by investigator assessment., • ORR determined by investigator assessment, • Duration of response (DOR; determined by both IRC and investigator assessment) defined as the time from first qualifying response (CR, CRi, nPR, or PR) until disease progression or death, • Time to next treatment (TTNT) defined as the time from randomization to the start of next treatment for CLL, • Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden, and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409 • PFS, defined as time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.

Начало: 20.04.2026 Възраст: от 18 г.

Czech Republic, France, Germany +3 BeOne Medicines I GmbH 2025-524366-21-00

Набира участници Фаза 2

A randomized phase II study comparing the safety and efficacy of mifamurtide and standard therapy containing sorafenib in pediatric and young adult patients with high-risk osteosarcoma

Relapsed/refractory osteosarcoma High-grade osteosarcoma

Trial status: Authorised OS (Overall Survival) – Overall survival will be measured from randomization to death from any cause; for patients alive at the end of follow-up, data will be censored at the date of last confirmed contact., PFS (Progression-Free Survival) – Progression-free survival will be measured from randomization to the date of disease progression or death, whichever occurs first., ORR (Overall Response Rate) – Response rate, defined as the percentage of patients with the best documented complete response (CR) or partial response (PR), assessed according to RECIST v1.1 at the time points specified in the imaging schedule., Evaluation of the safety of mifamurtide in patients with osteosarcoma. Safety will be assessed based on the number of serious adverse events (SAEs), the number of adverse events (AEs), a physical examination with analysis of recorded vital signs and laboratory abnormalities according to NCI CTCAE v5.0, from the start of treatment to the end of safety follow-up according to the study schedule. EFS (Event-Free Survival) – the time from randomization to the first event, i.e., death, disease progression, or disease relapse, whichever occurs first. Assessment will be conducted from the date of randomization to the date of the event or to the date of the last available assessment.

Начало: 20.04.2026 Възраст: 18–64 г.

Poland Instytut Matki I Dziecka 2026-525223-24-00

Набира участници Фаза 3

A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects with Non-permanent Atrial Fibrillation

Non-permanent Atrial Fibrillation

Trial status: Authorised Secondary Efficacy: • Change in percent AFSS during final month of treatment compared to baseline for multiple doses of budiodarone. • PGI-C during the final month of treatment. • Percent change in AFB during final month of treatment compared to baseline. Safety: • Incidence of TEAE and treatment-emergent serious adverse events (TESAE). • Incidence of AESI • Mortality and Clinical Morbidity Events: o Death o Resuscitated sudden cardiac death (SCD) including appropriate implanted cardiac defibrillator (ICD) discharge o Cardiovascular hospitalization o Stroke or another thromboembolic event • Physical Exam assessments and abnormalities. • Vital sign assessments and abnormalities. • Clinical laboratory assessment and abnormalities. o Thyroid functio, Primary Efficacy: • Proportion of participants that have no LEAF (uninterrupted episode of AF that is 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is greater than 5 hours) in the final month of treatment., Exploratory Endpoint: • The proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment

Начало: 20.04.2026 Възраст: от 18 г.

Poland Xyra LLC 2025-523860-19-00

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