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Намерени 282 изпитвания Стр. 5 от 15

Recruiting Phase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension (PAH)

Trial status: Authorised Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations, Change from baseline in mean pulmonary artery pressure, Change from baseline in cardiac output, Change from baseline in cardiac index, Change from baseline in right atrial pressure, Change from baseline in 6-Minute Walk Distance (6MWD), Concentrations of functional REGN13335 in plasma, Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma Change from baseline in Pulmonary Vascular Resistance (PVR)

Начало: 18.03.2026 Възраст: от 18 г.

Belgium, Czech Republic, France +4 Regeneron Pharmaceuticals Inc. 2024-514754-79-00

Recruiting Phase 2

SHIELD – Swift Hydrocortisone Intervention after trauma exposure

Posttraumatic Stress Disorder (PTSD)

Trial status: Authorised Status of PTSD diagnosis at 3 months (T4) after the intervention, measured with the CAPS-5., Self-reported PTSD symptom severity at 2 weeks (T1), 1 month (T2), 6 weeks (T3), 3 months (T4), 6 months (T5) and 12 months (T6) after the intervention, measured with the PCL-5., Scores on the questionnaires assessing other outcomes (IDS-SR, EQ-5D-5L, AUDIT, ISI) and SAEs at T1 to T6., Demographic data, scores on questionnaires (CTQ, LEC-5), wearable measuring heart rate (HR) and heart rate variability (HRV), intrusion and sleep diary, saliva sample collected at intake, self-composed questionnaires., Results of qualitative interviews with 20 participants of the trial PTSD symptom severity at 3 months (T4) after the intervention, measured with the CAPS-5 score.

Начало: 17.03.2026 Възраст: 18–64 г.

Netherlands Amsterdam UMC Stichting 2025-523350-13-02

Recruiting Phase 1

Safety and Preliminary Efficacy of CTX112 in Adult Participants with Relapsed/Refractory Hematologic Autoimmune Disease

Relapsed/Refractory Hematologic Autoimmune Disease

Trial status: Authorised

Начало: 12.03.2026 Възраст: от 18 г.

Germany, Spain CRISPR Therapeutics AG 2025-523845-90-00

Recruiting Phase 2

INTRATUMORAL DNX-2401 ADMINISTRATION FOR RECURRENT AND REFRACTORY HIGH GRADE BRAIN TUMORS IN PEDIATRIC AND YOUNG ADULT PATIENTS

High grade malignant brain neoplasm

Trial status: Authorised Number of AEs and SAEs per NCI-CTCAE criteria in first 12 weeks after DNX-2401 administration., Time to response., Duration of response., PFS, OS: 6- and 12- month PFS and OS rates., LPS/KPS and QoL (PedsQL™ Generic Score Scale) parameters compared to baseline. Overall response rate (ORR), defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD for at least 12 weeks) as best response according to RAPNO criteria.

Начало: 11.03.2026 Възраст: 18–64 г.

Netherlands, Spain Clinica Universidad De Navarra 2024-515009-24-00

Recruiting Phase 2

Ultimate dePletion of autoReactive b cells using Obinutuzumab from sjÖgren's syndrome affected Tissues study- UPROOT study

Sjögren's syndrome

Trial status: Authorised - Change from baseline in ESSDAI score at Week 12, 24 and 36 (11)., - Proportion of patients achieving ≥3 points reduction from baseline in ESSDAIscore at Week 12, 24 and 36., - Proportion of patients achieving ESSDAI

Начало: 11.03.2026 Възраст: от 18 г.

Netherlands Radboud universitair medisch centrum Stichting 2024-519884-16-00

Recruiting Phase 2

B7981119 A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 16-Week Study Evaluating the Safety and Efficacy of Ritlecitinib (PF-06651600) in Adults with Moderate to Severe Hidradenitis Suppurativa

HIDRADENITIS SUPPURATIVA

Trial status: Authorised HiSCR50 response at Weeks 1, 2, 4, 6, 8, and Week 12., HiSCR75 response at Weeks 1, 2, 4, 6, 8, 12 and Week 16., HiSCR90 response at Weeks 1, 2, 4, 6, 8, 12 and Week 16., Response based on a total abscess and nodule (AN) count of 0 or 1 at Week 16., Response based on a total AN count of 0, 1, or 2 at Week 16., Percent (%) change from baseline (CFB) in total AN count at Weeks 1, 2, 4, 6, 8, 12 and 16., Absolute score and CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16., Response based on achieving a HS-IGA=0 or 1 at Weeks 1, 2, 4, 6, 8, 12 and 16., Participants who experience an HS flare, defined as at least a 25% increase in total AN count with a minimum increase of 2 relative to Baseline, at Weeks 4, 8, 12 and 16., CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) at Weeks 1, 2, 4, 6, 8, 12 and 16., Skin pain NRS30 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain numeric rating scale (NRS) ≥3., %CFB in skin pain NRS, at worst and on average, respectively, in participants with baseline skin pain NRS ≥3, at Weeks 1, 2, 4, 6, 8, 12, and 16., CFB in skin pain NRS, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16., Skin pain NRS50 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain NRS ≥3., Skin pain NRS70 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain NRS ≥3., Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation, Incidence of clinically significant laboratory abnormalities over time, Absolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Weeks 1, 2, 4, 6, 8, 12 and 16., Absolute score and % CFB in IHS4 at Weeks 1, 2, 4, 6, 8, 12 and 16. HiSCR50 response at Week 16

Начало: 11.03.2026 Възраст: от 18 г.

Germany, Greece, Poland +1 Pfizer Inc. 2025-522705-37-00

Recruiting Phase 3

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Depressive episodes associated with Bipolar disorder I or II (Bipolar Depression)

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

Начало: 10.03.2026 Възраст: от 18 г.

Bulgaria, Germany, Poland +1 Xenon Pharmaceuticals Inc. 2025-522775-29-00

Recruiting Phase 1

The clinical trial to study a new drug, AP-2.

ALS and related disorders like frontotemporal dementia and Alexander disease.

Trial status: Authorised

Начало: 10.03.2026 Възраст: 18–64 г.

Spain Molefy Pharma S.L. 2025-524480-21-00

Recruiting Phase 4

Intrathecal drug delivery systems versus comprehensive medical management for severe cancer pain: a randomized controlled trial

Severe refractory cancer pain

Trial status: Authorised Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental, and social dimension., The survival rate in both groups, CMM and IDD, will be determined by recording the time from treatment initiation until death., Pain intensity will be measured with the VAS (ranging from 0 (no pain) to 100 (maximal pain)) in electronic format., Perceived stress will be assessed by using the 10-item Perceived Stress Scale (PSS; Cohen, Kamarch, & Mermelstein, 1983)., Patient anxiety will be provided through the State Trait Anxiety Inventory (STAI)., Using the Injustice Experience Questionnaire (IEQ), perceived injustice related to current health status will be assessed., The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy., To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed., Expenditures related to in-hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted each month after treatment initiation. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, AEs, changes in medication (daily morphine or MED), or incurred any additional healthcare costs., Safety, all (S)AEs will be documented throughout the duration of the study. HRQoL will be evaluated with the EORTC QLQ-C30 questionnaire.

Начало: 04.03.2026 Възраст: от 18 г.

Belgium Vrije Universiteit Brussel 2025-522381-68-00

Recruiting Phase 2

A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 versus Standard of Care (Liposomal Amphotericin B followed by Voriconazole) for Early Antifungal Therapy of Suspected Invasive Mould Infections

Suspected Invasive Mould Infection

Trial status: Authorised 1_Overall success at Day 42, confirmed by the Data Review Committee (DRC), in the population with proven or probable IA (modified Intent-to-Treat [mITT]) as measured by: - Participant is alive, - favorable composite clinical, mycologic, and radiographic response (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group [EORTC/MSG] criteria), 2_Early antifungal therapy (EAT) success at Day 42 in the ITT analysis set defined by non-occurrence of the following: death, receipt of non-study drug systemic antifungal therapy for a cumulative exposure >10 days for progression of disease and/or toxicity, missing data (classified as indeterminate but analyzed as a failure), 3_Breakthrough possible, probable, or proven IFI established after 14 days of study drug in the ITT analysis set, 4_Duration of the initial hospitalization after randomization, in the ITT analysis set, 5_Motif et durée de réhospitalisation après la sortie d’hôpital à l’issue de l’hospitalisation initiale, dans l’ensemble d’analyse ITT 1_All-cause mortality at Day 42 in the Intent-to-Treat (ITT) analysis set, 2_Serious adverse events (SAEs) and treatment emergent adverse events (TEAEs) categorized in a tiered approach in the Safety analysis set. Tier1 TEAEs include renal, electrolyte, hepatic, infusion-related reactions, photophobia, and photosensitivity. Tier 2 includes all other TEAEs

Начало: 26.02.2026 Възраст: от 18 г.

Belgium, France, Italy +1 Elion Therapeutics Inc. 2025-522835-32-00

Recruiting Phase 2

A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults with Major Depressive Disorder

Major Depressive Disorder

Trial status: Authorised This will be assessed by reviewing the change in the participants score of the depression rating scale called Montgomery Åsberg Depression Rating Scale (MADRS)

Начало: 24.02.2026 Възраст: от 18 г.

Bulgaria, Czech Republic, Poland Draig Therapeutics Limited 2025-522784-15-00

Recruiting Phase 4

A multi-center, open label, longitudinal, observational, 12-week study of Flexilev treatment with the dosing device OraFID and accompanying digital app in Parkinson patients.

Parkinsons Disease

Trial status: Authorised Self-reported using questionnaire regarding the app (self-reported in Patients Own Registration in “Parkinsonregistret”), Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”), Data obtained from the app Levilog and drug accountability records., Compliance with APP (Levilog) – and treatment data from use of APP (self-reported in Patients Own Registration in “Parkinsonregistret” + data obtained from the app), Safety reporting; adverse event and serious adverse events,withdrawals, Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”), Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”), NMSQ, Non-Motor Symptoms Questionnaire (NMSQ self-reported in Patients Own Registration in “Parkinsonregistret”)., HADS-D, Hospital Anxiety and Depression Scale, (HADS-D self-reported in Patients Own Registration in “Parkinsonregistret”)., PDQ-8, Parkinson's disease quality-of-life scale, and the EQ5D-5L (EuroQol) generic quality of life scale, together with the associated 0 to 100-point visual analog scale (VAS), (self-reported in Patients Own Registration in “Parkinsonregistret”)., OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”)., OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”)., PDSS-2 questionnaire (PDSS-2 self-reported in Patients Own Registration in “Parkinsonregistret”)., OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”)., UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”), UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”), CISI-PD, Clinical Impression of Severity Index for Parkinson’s Disease (Physician reported in “Parkinsonregistret”), The PRO-PD, Patient-Reported Outcomes in Parkinson's Disease, (PRO-PD self-reported in Patients Own Registration in “Parkinsonregistret”). Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)

Начало: 24.02.2026 Възраст: от 18 г.

Sweden Navamedic AB 2025-524296-23-01

Recruiting Phase 2

An open-label, single-center, non-controlled pilot clinical trial to assess the efficacy of weekly semaglutide in combination with regular counselling sessions to reduce craving and use of chemsex associated drugs (CoSem4Chemsex) study.

Craving for and use of chemsex-related drugs

Trial status: Authorised Self-reported use CADs, Self-reported use crystallized methamphetamine, Self-reported use cathinones, Self-reported use GHB/GBL, Craving for crystallized methamphetamine at baseline and end of treatment, Craving for cathinones at baseline and end of treatment, Craving for GHB/GBL at baseline and end of treatment, Craving for alcohol at baseline and end of treatment, Quality of life at baseline and end of treatment, Craving for CADs (sum of craving for cathinones + crystallized methamphetamine + GHB/GBL) at baseline and end of treatment (VAS), The cumulative proportion of participants reporting grade 3 to 5 of each side effect listed in the SAFTEE form over the course of the study whilst receiving semaglutide Craving for CADs (the highest craving score for cathinones / crystallized methamphetamine / GHB/GBL) at baseline and each subsequent study visit (Penn Craving Score)

Начало: 12.02.2026 Възраст: от 18 г.

Belgium Institute Of Tropical Medicine 2025-524177-16-00

Recruiting Phase 3

HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP).

X-Linked Protoporphyria (XLP) Erythropoietic Protoporphyria (EPP)

Trial status: Authorised 1. Change from baseline in daylight tolerance, as assessed by total hours spent in sunlight without pain and average time to first prodromal syndrome in sunlight., 2. Percent change from baseline in whole blood metal-free PPIX concentrations., 3. Plasma bitopertin concentrations. Safety and tolerability of bitopertin, as assessed by the incidence of treatmentemergent adverse events (TEAEs), vital signs, physical examinations, and clinical laboratory parameters.

Начало: 12.02.2026 Възраст: от 18 г.

Belgium, France, Germany +6 Disc Medicine Inc. 2025-523275-27-00

Recruiting Phase 2

A Phase 2 Open-label Multicenter study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in children from 2 years to less than 18 years of age with generalized Myasthenia Gravis (gMG)

Generalized Myasthenia Gravis

Trial status: Authorised Change in Quantitative Myasthenia Gravis (QMG) score, Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, Presence of anti-drug antibodies (ADAs) "Pharmacokinetic parameters, including maximum observed concentration (Cmax), area under the concentration-time curve (AUC), halflife (t1/2), clearance (CL) and volume of distribution at steady state (Vss)", Change from baseline in cluster of differentiation 20 (CD20)+ B-cell counts, "Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of interest", Changes in laboratory parameters, Changes in vital signs

Начало: 09.02.2026

France, Italy, Poland +1 Amgen Inc. 2025-520993-20-00

Recruiting Phase 3

A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis

Immune system diseases

Trial status: Authorised Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission., Proportion of participants with no bowel urgency., Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS- Fatigue Short Form 7a T-score., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by mMS, in the subset of participants who achieved clinical remission by mMs at the end of induction period (maintenance of clinical remission)., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS)., Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score., Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission., Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission and no steroid use from the baseline to the time of endpoint analysis., Pivotal Maintenance Sub-Study Cohort 1: Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation., Pivotal Maintenance Sub-Study Cohort 1: Serum concentration of duvakitug measured over time., Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug., Open-Label Extension Sub-Study: Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation. Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).

Начало: 09.02.2026 Възраст: от 18 г.

Austria, Belgium, Bulgaria +12 Sanofi-Aventis Recherche & Developpement 2025-521038-27-00

Recruiting Phase 4

Caffeine Administration for Preterms: Pharmacokinetics, Utilization and Correlation Inhibiting Nociception Outcome

Primary apnea in preterms newborns

Trial status: Authorised 1. a) Proportion of preterm newborns in whom the concentrations of caffeine and paraxanthine can be reliably measured from saliva samples., 2. a) Salivary caffeine concentrations over time b) Relationship between caffeine dose and concentration over time., 3. a) Relationship between salivary caffeine concentrations and: • Frequency (Apnea of Prematurity events per 24 hours) and severity of apneic episodes (detail in Section 6.7.3.) • The need for respiratory support, considering its duration and type • Time to successful withdrawal of caffeine therapy, 4. a) Incidence of prematurity-related complications: BPD, ROP, PDA, periventricular hemorrhage/intraventricular hemorrhage (PVH/IVH), periventricular leukomalacia (PVL), posthemorrhagic hydrocephalus (PHH), neonatal seizures, and others., 5. a) Evaluation of pain assessment scores (COMFORTneo Scale) and vital function parameters (heart rate, blood pressure) in relation to concentration and exposure duration., 6. a) Comparison of the incidence and severity of adverse events of special interest (AESI) related to caffeine therapy in relation to caffeine concentration levels: • CVS: Tachycardia (for definition see Section 6.7.2) • CNS: Convulsion, brain injury, irritability, jitters, shaking • GIT: Feeding intolerance, necrotizing enterocolitis • Investigations: Urine output increased, Exploratory endpoints 2. a) CYP1A2 metabolic activity (caffeine/paraxanthine ratio in saliva) in both GA subgroups and correlation with caffeine therapy duration. b) Evaluation of the analgesic effect of caffeine in relation to CYP1A2 metabolic activity. c) Relationship between CYP1A2 metabolic phenotype and treatment efficacy or caffeine-related adverse events (e.g., tachycardia, feeding intolerance). a) Exploration of observed caffeine concentration levels in groups of preterm newborns receiving caffeine therapy, stratified by treatment response as defined by the duration of IRS evaluated on Day 11 and at 36 weeks of postmenstrual age (PMA).

Начало: 09.02.2026

Czech Republic Masarykova Univerzita 2025-523475-33-00

Recruiting Phase 2

A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease

Sickle Cell Disease

Trial status: Authorised • Incidence of AEs, SAEs, and AEs related to etavopivat (extension period) • Number of premature discontinuations, dose interruptions, and dose reductions (extension period), • Hb response rate at Weeks 12 and 24 (increase of > 1 g/dL from baseline) • Change in Hb from baseline at Weeks 12 and 24, Incidence of VOCs during the 24-week primary treatment period o Number of VOCs o Annualized Rate of VOC, Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Weeks 12 and 24 (between 5 to 18 years of age), Change from baseline in time-averaged mean of the maximum velocity (TAMMV) by transcranial Doppler ultrasonography (TCD) (> 2 years of age) • Single-dose: maximum concentration (Cmax), area under the concentration time curve (AUC)0-t, AUC0-inf • Steady-state etavopivat plasma exposure (Cmax,ss, AUCtau,ss, Cavg,ss, Cmin,ss) • Estimated using population PK • Incidence of AEs, SAEs, and AEs related to etavopivat • Number of premature discontinuations, dose interruptions, and dose reductions.

Начало: 06.02.2026

France Novo Nordisk A/S 2024-519881-32-00

Recruiting Phase 4

Tailored antiplatelet secondary prevention in non-cardioembolic ischemic stroke: a phase IV gender-stratified randomized controlled trial (TAILOR trial)

Non-cardioembolic ischemic stroke

Trial status: Authorised Adherence to treatment, tested at the 3-month and 12-month follow-up visit via: • Rate of ‘good adherence’ (score ≥20) at the 5-item Medication Adherence Report Scale (MARS-5, total score 5–25). • Rate of responder status (ASPI/ADP based on appropriate drug) at the follow-up aggregation test., Good Functional status at 12 months, defined and adjudicated according to modified Rankin Scale 0-2., 12-month single-items of the composite primary outcome., 12-month incidence of single-items of the composite safety outcome., Gender differences in the primary and secondary outcomes, Prevalence in CYP2C192 and CYP2C1917 polymorphisms rate between responders and non-responders., 3-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death., 12-month incidence of major and minor bleeding (composite safety outcome). 12-month cumulative incidence (time to first event) of the composite of ischemic stroke, myocardial infarction, or cardiovascular death.

Начало: 28.01.2026 Възраст: от 18 г.

Italy Azienda Unita Sanitaria Locale Di Bologna 2025-523065-16-00

Recruiting Phase 4

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)

Moderate to Severe Plaque Psoriasis

Trial status: Authorised Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster, SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation, Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization

Начало: 19.01.2026 Възраст: от 18 г.

Belgium, Bulgaria, Czech Republic +9 Bristol-Myers Squibb Services Unlimited Company 2023-503766-24-00

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