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Намерени 282 изпитвания Стр. 9 от 15

Активно (без набиране) Фаза 3

I4V-MC-JAJK: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to

Diabetes Mellitus Type 1

Trial status: Authorised Change from Baseline in C-peptide Area Under the Curve (AUC) [Time Frame: Baseline, Week 52]

Начало: 02.02.2026 Възраст: 18–64 г.

Belgium, Czech Republic, Finland +9 Eli Lilly & Co. 2025-522170-36-00

Активно (без набиране) Фаза 3

A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM).

Symptomatic genetic and familial dilated cardiomyopathy.

Trial status: Authorised Change from Baseline (Day 1) to Week 26 in left atrial function index (LAFI) in Cohort 1., Change from Baseline (Day 1) to Week 26 in peak oxygen consumption (pVO2) in Cohort 1.

Начало: 30.01.2026 Възраст: от 18 г.

Belgium, Denmark, France +6 Kardigan Inc. 2025-522553-19-00

Активно (без набиране) Фаза 3

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OF NEOADJUVANT DAROVASERTIB IN SUBJECTS WITH PRIMARY NON-METASTATIC UVEAL MELANOMA (OptimUM-10)

Uveal Melanoma

Trial status: Authorised Both Cohorts: ORR_UM, defined as the rate of best overall response (complete response [CR] or partial response [PR]) Response defined as: o CR: Complete regression of tumor by ultrasound (US) and fundus photography (FP); o PR: Decrease in product of diameters by US and/or FP by ≥ 20% or decrease in thickness by US by ≥ 20% from baseline;, Both Cohorts: EFS, defined as the time from randomization to the first documented date of treatment failure (including disease progression, local/distant recurrence, or death, whichever occurs first), Both Cohorts: Incidence of all treatment-emergent AEs (TEAEs), serious adverse events (SAEs) and clinically significant laboratory test abnormalities, and changes to electrocardiograms (ECGs) and vital signs, Both Cohorts: • ORR_UM • DCR, defined as the proportion of CR, PR, or SD, Both Cohorts: Proportion of subjects with improvement in ETDRS BCVA letters and/or Snellen lines, Cohort 1: Proportion of subjects with clinically significant ME (%ME defined optical coherence tomography [OCT] finding, vision loss, and initiation of vascular endothelial growth factor inhibitor [VEGFi] administration) measured from the time of randomization and completion of PB, Cohort 1: Proportion of subjects with 20/200 vision or worse (%20/200) from the time of randomization and completion of PB, Cohort 1: Proportion of subjects with significant reduction of radiation dose (defined as a ≥ 20% reduction) delivered to key eye structures including, but not limited to, the macula, optic disc/nerve, and lens, Cohort 1:Proportion of subjects with ME on OCT from the time of completion of PB ME by OCT defined as the presence of intraretinal fluid (cystoid edema) on OCT, Cohort 1:Proportion of subjects with radiationrelated ocular toxicities at 6, 12, 18, 24, 30, and 36 months post PB • The incidence and severity of radiation induced ocular toxicities Cohort 1: Proportion of moderate to high risk of visual impairment (MHRVI) subjects with loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA (%VL15) measured from the time of randomization and completion of PB, Cohort 2: Eye preservation rate

Начало: 29.01.2026 Възраст: от 18 г.

Austria, Belgium, Czech Republic +7 Ideaya Biosciences Inc. 2025-522387-32-00

Активно (без набиране) Фаза 2

A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis

Progressive Forms of Multiple Sclerosis (PMS)

Trial status: Authorised Time from randomization to the first occurrence of 24-week confirmed ≥ 4-point decrease (worsening) in Symbol Digit Modalities Test (SDMT), Plasma 2-arachidonoylglycreol (2-AG) levels, Change from baseline in plasma 2-AG levels, Incidence, severity, and causal relationship of adverse events (AEs), Incidence of treatment discontinuations due to AEs, Changes in vital signs and ECG parameters, Incidence of abnormal laboratory findings, Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS), Plasma concentrations of RO7268489 and its metabolite(s) as appropriate Time from randomization to the first occurrence of composite confirmed disability progression confirmed for at least 12 weeks (cCDP12) according to at least one of the following three criteria: o 12-week confirmed disability progression (CDP12) o 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or o 12-week confirmed increase in 9-Hole Peg Test (9-HPT)

Начало: 28.01.2026 Възраст: 18–64 г.

France, Germany, Hungary +4 F. Hoffmann-La Roche AG 2025-521636-10-00

Активно (без набиране) Фаза 3

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

Major Depressive Disorder

Trial status: Authorised Change from baseline in the SHAPS score at Week 6, Change from baseline in the HAMD-17 score at Week 1, Change from baseline in the CGI-S score at Week 6 Change from baseline in the HAMD-17 score at Week 6.

Начало: 26.01.2026 Възраст: от 18 г.

Czech Republic, Finland, Poland +3 Xenon Pharmaceuticals Inc. 2025-523202-32-00

Активно (без набиране) Фаза 2

Master Protocol: A Phase 1b / 2, Multicenter, Multi Arm Study of Evorpacept in Combination with Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09) Substudy Protocol: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination with Trastuzumab and Chemotherapy in Participants with Metastatic HER2-Positive Breast Cancer (ASPEN-09-03)

Breast Cancer

Trial status: Authorised • ORR based on Investigator assessment., • Clinical Benefit Rate (CBR), Duration of Response (DoR), and Progression Free Survival (PFS), using RECIST v1.1 based on BICR and Investigator assessment, and Overall Survival (OS)., • Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]), timing, seriousness, and relationship to study drug., • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0) and timing., • PK parameters of evorpacept such as maximum concentration (Cmax), time at maximum concentration (Tmax), area under the concentration-time curve (AUC), clearance (CL), and terminal elimination half-life (t1/2) as data permit., • Presence of human serum anti-drug antibodies (ADAs) (anti-evorpacept antibodies). Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on Blinded Independent Central Review (BICR) assessment.

Начало: 23.01.2026 Възраст: от 18 г.

France, Italy, Spain Alx Oncology Holdings Inc. 2025-522012-16-00

Активно (без набиране) Фаза 3

Phase 3 Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent and Adult Subjects with Homozygous Familial Hypercholesterolemia (YOSEMITE)

Homozygous Familial Hypercholesterolemia (HoFH)

Trial status: Authorised 1. Percent Change from Baseline to Month 12 in Fasting Apolipoprotein B (ApoB) (Randomized Period), 2. Percent Change from Baseline to Month 12 in Fasting Non-High Density Lipoprotein Cholesterol (non-HDL-C) (Randomized Period), 3. Change from Baseline to Month 12 in Fasting LDL-C (Randomized Period), 4. Area Under the Plasma Concentration Versus the Time Curve (AUC) from Baseline to Month 12 for Fasting LDL-C (Randomized Period), 5. Percent Change from Baseline to Month 12 in Fasting Triglycerides (TGs) (Randomized Period), 6. Percent Change from Baseline to Month 12 in Fasting Angiopoietin-like Protein 3 (ANGPTL3) (Randomized Period), 7. Percent Change from Baseline to Month 12 in Fasting Total Cholesterol (Randomized Period), 8. Percent Change from Baseline to Month 12 in Fasting High-Density Lipoprotein Cholesterol (HDL-C) (Randomized Period), 9. Proportion of Participants who Meet European Union (EU) LDL-C Apheresis Eligibility Criteria (per German Apheresis Working Group) at Month 12 (Randomized Period), 10. Proportion of Participants who Meet United States (US) Apheresis Eligibility Criteria (per National Lipid Association) at Month 12 (Randomized Period), 11. Proportion of Participants with Fasting LDL-C

Начало: 23.01.2026 Възраст: от 18 г.

Austria, Belgium, Czech Republic +7 Arrowhead Pharmaceuticals Inc. 2025-521792-31-01

Активно (без набиране) Фаза 2

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Dose Comparison and Exploratory Efficacy Study of Orally Administered SAT-3247 in Ambulatory DMD Patients

Duchenne muscular dystrophy

Trial status: Authorised Changes from baseline in intramuscular fat fraction in muscle quantitative magnetic resonance (qMR) in vastus lateralis at Week 12, Changes from baseline in proton muscle transverse relaxation time (T2) in vastus lateralis at Week 12., Changes from baseline in Regeneration Index in open muscle biopsy of the biceps brachii at Week 12, Changes from baseline in function as determined by NSAA assessment at Week 12, Changes from baseline in SV95C at Week 12, Exploratory end point: change from baseline in inflammatory cytokine profile at Week 12, Exploratory end point: change from baseline in creatine kinase at Week 12, Exploratory end point: change from baseline in maximum percent predicted forced vial capacity as measured by spirometry at Week 12, Exploratory end point: change in biceps brachii muscle fiber size and fiber size distribution as determined from histopathology at 12 weeks, Exploratory end point: change in the proportion of embryonic myosin positive fibers as determined from histopathology at 12 weeks., Exploratory end point: change in the number of satellite cells as determined from histopathology at 12 weeks, Exploratory end point: change in endomysial fibrosis and adipose tissue infiltration as determined from histopathology at 12 weeks., Exploratory end point: change in NSAA score over 12 weeks as compared to natural history The primary efficacy endpoint is defined as the change from baseline in muscle force measurements as determined by dynamometry at Week 12., Safety endpoints include incidence, severity, and relationship to SAT-3247 of adverse events as well as occurrence of clinically significant changes in physical examination, clinical laboratory measures, vital signs, ECG, and C-SSRS

Начало: 22.01.2026

Belgium, Poland, Spain Satellos Bioscience Inc. 2025-522522-13-01

Активно (без набиране) Фаза 4

International multicentre, open-label, phase IV clinical trial to evaluate the efficacy, safety and effect on quality of life of bilastine in children with allergic rhinoconjunctivitis

Allergic rhinoconjunctivitis

Trial status: Authorised Overall AR symptoms will be evaluated through the mean change of the T5CSS score measured at baseline (V1) and after 14 days (V3) of treatment by a participant’s e-diary

Начало: 19.01.2026

Italy, Poland, Spain Faes Farma S.A., A. Menarini Industrie Farmaceutiche Ri 2024-519550-36-00

Активно (без набиране) Фаза 3

Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations

Non-small cell lung cancer

Trial status: Authorised OS, defined as the time from randomization until death from any cause, Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier

Начало: 19.01.2026 Възраст: от 18 г.

Austria, Belgium, Denmark +9 Boehringer Ingelheim International GmbH, Boehringer Ing 2025-521284-12-00

Активно (без набиране) Фаза 4

Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)

Bipolar disorder

Trial status: Authorised Hamilton D6, Pittsburgh Sleep Quality, Young Mania Rating Scale, Functioning Assessment Short Test (FAST), internet-based Cognition Assessment Tool (ICAT) and bloodbased inflammation markers in bloodsamples, hair cortisol and urine oxidative stress markers Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system

Начало: 16.01.2026 Възраст: 18–64 г.

Denmark Region Hovedstaden 2025-523549-92-00

Активно (без набиране) Фаза 3

An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX

Hemophilia

Trial status: Authorised Annualized spontaneous bleeding rate (AsBR) in the fitusiran primary efficacy period and in the SOC period., Annualized joint bleeding rate (AjBR) in the fitusiran primary efficacy period and in the SOC period, ABR in the fitusiran treatment period (160 weeks) for fitusiran-naïve participants., ABR in the fitusiran treatment period (60 weeks) for rolled-over participants, Change in physical activity, Change in pain intensity, Change in HRQoL, Incidence, severity, seriousness, and relatedness of adverse events (AEs), Change in total score and domain scores, Target joints resolution Annualized treated bleeding rate (ABR) in the fitusiran primary efficacy period and in the SOC period.

Начало: 15.01.2026

Belgium, Germany, Hungary +4 Sanofi-Aventis Recherche & Developpement 2025-521858-42-00

Активно (без набиране) Фаза 3

HOVON 181 AML: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study

Acute Myeloid Leukemia

Trial status: Authorised EFS, defined as the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first.

Начало: 15.01.2026 Възраст: от 18 г.

Austria, Belgium, Denmark +9 Hemato-Oncologie voor Volwassenen Nederland (Hovon) Sti 2025-522767-15-00

Активно (без набиране) Фаза 3

I4V-MC-JAJJ: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to

Diabetes Mellitus Type 1

Trial status: Authorised Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [Time Frame: Baseline up to approximately 5 years]

Начало: 23.12.2025 Възраст: 18–64 г.

Belgium, Finland, France +8 Eli Lilly & Co. 2025-521797-34-00

Активно (без набиране) Фаза 2

A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa

Hidradenitis suppurativa

Trial status: Authorised Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody responses. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Начало: 22.12.2025 Възраст: от 18 г.

Czech Republic, France, Germany +6 Sanofi-Aventis Recherche & Developpement 2025-522333-61-00

Активно (без набиране) Фаза 2

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo.

Non-segmental vitiligo

Trial status: Authorised Percent change from baseline in the F-VASI at Week 24, Percent change from baseline in the T-VASI at Week 24, Proportion of participants achieving ≥50% improvement from baseline in F-VASI at Week 24, Proportion of participants achieving ≥50% improvement from baseline in T-VASI at Week 24 Proportion of participants achieving ≥75% improvement from baseline in F-VASI at Week 24.

Начало: 19.12.2025 Възраст: от 18 г.

France, Italy, Poland +1 Takeda Development Center Americas Inc. 2025-522309-40-00

Активно (без набиране) Фаза 1

A Phase I Interventional Open-Label, Non-Randomized Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-Tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients with Selected Advanced Cancers. Catherine Trial

Locally advanced recurrent or metastatic breast gastric +2

Trial status: Authorised

Начало: 17.12.2025 Възраст: от 18 г.

Spain Vall D Hebron Institute Of Oncology 2024-516660-28-01

Активно (без набиране) Фаза 2

A Phase 2, Open-label, Basket Study Investigating the Safety and Efficacy of GTX-102 in Adult and Pediatric Subjects with Deletion- or Nondeletion-type Angelman Syndrome

Angelman Syndrome

Trial status: Authorised Subprotocol GTX-102-CL210A - Change from Baseline at Day 338 in: Bayley-4 Receptive Communication raw score, Bayley-4 Gross Motor raw score, Subprotocol GTX-102-CL210B - Change from Baseline at Day 338 in: Bayley-4 Cognitive raw score, Bayley-4 Receptive Communication raw score, Vineland-3 Receptive Communication raw score, Vineland-3 Expressive Communication raw score, ABC-C Hyperactivity/Noncompliance subscale score, ASA Sleep rating, ASA Gross Motor rating, Bayley-4 Gross Motor raw score., Subprotocol GTX-102-CL210C - Change from Baseline at Day 338 in: Vineland-3 Receptive Communication raw score, Vineland-3 Expressive Communication raw score, ABC-C Irritability subscale score, ASA Gross Motor rating., Subprotocol GTX-102-CL210D - Change from Baseline (or pretreatment) at TxD 338: Bayley-4 Cognitive raw score, Bayley-4 Receptive Communication raw score, Vineland-3 Receptive Communication raw score, Vineland-3 Expressive Communication raw score, ABC-C Hyperactivity/Noncompliance subscale score, ASA Sleep rating, ASA Gross Motor rating, Bayley-4 Gross Motor raw score. All Subprotocols - Primary Safety Endpoint: TEAEs and SAEs, frequency, severity, and relationship to investigational product, procedure, and premedication throughout the study., Subprotocol GTX-102-CL210A - Primary Efficacy Endpoint: Bayley-4 Cognitive raw score without caregiver input, change from Baseline at Day 338., Subprotocol GTX-102-CL210B - Primary Efficacy Endpoint: MDRI Net response at Day 338, with the following domains - assessments: Cognition - Bayley-4 Cognitive raw score, Communication - Bayley-4 Receptive Communication raw score, Behavior - ABC-C Hyperactivity/Noncompliance, Sleep - ASA Sleep rating, Motor Function - ASA Gross Motor rating., Subprotocol GTX-102-CL210C - Primary Efficacy Endpoint: MDRI Net response at Day 338, with the following domains - assessments: Expressive Communication - Vineland-3 Expressive Communication raw score, Receptive Communication – Vineland-3 Receptive Communication raw score, Behavior - ABC-C Irritability subscale score, Motor Function - ASA Gross Motor rating., Subprotocol GTX-102-CL210D - Primary Efficacy Endpoint: MDRI Net response at TxD 338, with the following domains - assessments: Cognition - Bayley-4 Cognitive raw score, Communication - Bayley-4 Receptive Communication raw score, Behavior - ABC-C Hyperactivity/Noncompliance, Sleep - ASA Sleep rating, Motor Function - ASA Gross Motor rating.

Начало: 11.12.2025 Възраст: 18–64 г.

France, Italy, Portugal Ultragenyx Pharmaceutical Inc. 2024-519393-39-00

Активно (без набиране) Фаза 3

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia

Classic Congenital Adrenal Hyperplasia

Trial status: Authorised Percent change from baseline of morning A4 at Week 2 Percent change from baseline of morning 17-OHP at Week 32  Proportion of participants with morning pre-GC A4 ≤ULN who are on physiologic GC replacement at Week 32  Percent change from baseline in GC daily dose when morning post-GC A4 ≤ULN at week 32 Proportion of participants with morning post-GC A4 ≤ULN who are on physiologic GC replacement at Week 32

Начало: 02.12.2025 Възраст: от 18 г.

Austria, France, Germany +4 Crinetics Pharmaceuticals Inc. 2024-519579-24-00

Активно (без набиране) Фаза 3

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Pulmonary Arterial Hypertension (PAH)

Trial status: Authorised Change From Baseline in 6-Minute Walk Distance (6MWD), Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels, Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC), Change From Baseline in Pulmonary Vascular Resistance (PVR), Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Number of Participants With Detectable Anti-drug Antibodies (ADAs), Hematology Parameters: Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit, Chemistry Parameters: Concentration of Blood Urea,Creatinine,Total & Direct Bilirubin,Aspartate Aminotransferase,Alanine Transaminase,Alkaline Phosphatase,Sodium,Potassium,Chloride,Calcium,Phosphorous,Glucose,Magnesium,Carbon Dioxide, & Albumin, Change From Baseline in Body Weight, Change From Baseline in Blood Pressure, Change From Baseline in Electrocardiogram (ECG)

Начало: 01.12.2025 Възраст: от 18 г.

Belgium, Croatia, Czech Republic +10 Merck Sharp & Dohme LLC 2025-521970-33-00

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