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Намерени 282 изпитвания Стр. 14 от 15

Активно (без набиране) Фаза 2

A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults with Tourette Syndrome

Tourette's syndrome in adults (≥18 and ≤65 years) in out-patient care

Trial status: Authorised [CCI], [CCI], [CCI], [CCI], [CCI], [CCI], [CCI], Number of adverse events (AEs), number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs leading to withdrawal at each visit., Absolute values of vital signs (blood pressure, heart rate) at each visit and change from baseline for each visit. Number and percentage of clinically significant abnormal values. [CCI]

Начало: 05.07.2024 Възраст: от 18 г.

Germany Neurothera Labs Inc. 2024-512949-17-00

Активно (без набиране) Фаза 3

Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

Generalized Myasthenia Gravis

Trial status: Authorised Incidence and severity of AEs, incidence of serious AEs (SAEs), incidence of AEs of special interest (AESIs), and changes in laboratory test results, physical examination results, vital sign measurements, and electrocardiogram (ECG) (part B only for ECGs), Efgartigimod serum concentrations, Levels of total IgG and AChR-Ab: absolute values, change from baseline and percent (%) change from baseline, Incidence and prevalence of antidrug antibodies (ADAs) against efgartigimod, MG-ADL total score: absolute value and change from baseline total MG-ADL score, Total QMG score: absolute value and change from baseline, Total score EQ-5D-Y: absolute value and change from baseline, Quality of Life in Neurological Disorders (Neuro-QoL) Pediatric Fatigue Score: values and change from baseline, Change in protective antibody titers to vaccines received before or received during the trial Efgartigimod concentrations as input for compartmental, model-driven analysis to determine age and size dependency of clearance and volume of distribution, PD parameters: total IgG levels and anti-acetylcholine receptors antibodies (AChR-Ab) as input for PK/PD modeling analysis

Начало: 24.06.2024

Belgium, France, Germany +4 Argenx 2024-513854-31-00

Активно (без набиране) Фаза 2

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors

Advanced Solid Tumors

Trial status: Authorised Dose Escalation/Evaluation (Monotherapy and Combination Therapy): Assessment by iRECIST and RECIST 1.1: o Objective Response Rate (ORR) o Clinical Benefit Rate (CBR) o Disease Control Rate (DCR) o Duration of Response (DOR) o Time to Response (TTR) o Progression Free Survival (PFS) o Best Overall Response (BOR)., Dose Escalation/Evaluation (Monotherapy and Combination Therapy): Overall Survival (OS)., Dose Escalation/Evaluation (Monotherapy and Combination Therapy): PK profile may include but are not limited to maximum concentration (Cmax), time to reach Cmax (Tmax), area under the curve (AUC), clearance (CL), half-life (t1/2), etc., Dose Escalation/Evaluation (Monotherapy and Combination Therapy): Incidence and persistence of anti-drug antibodies (ADA) to MDNA11., Dose Escalation/Evaluation (Monotherapy and Combination Therapy): Measurement of translational parameters., Dose Escalation/Evaluation (Monotherapy and Combination Therapy): Measurement of cytokines., Dose Expansion (Monotherapy and Combination Therapy): Measurement of translational parameters., Dose Expansion (Monotherapy and Combination Therapy): Measurement of biomarkers, including but not limited to immune cell lineages and markers of functional status such as determined by quantitative multiparameter immunofluorescence analysis., Dose Expansion (Monotherapy and Combination Therapy): PK profile may include but are not limited to Cmax, Tmax, AUC, CL, t1/2, etc., Dose Expansion (Monotherapy and Combination Therapy): Incidence and persistence of ADA to MDNA11., Exploratory (applicable to all study parts except where indicated): Measurement of translational parameters., Exploratory (applicable to all study parts except where indicated): Effect of baseline prognostic factors [e.g., lymphocyte count, lymphocyte to neutrophil ratio (LNR), C-Reactive Protein (CRP) levels, Lactate Dehydrogenase (LDH), etc.] on efficacy endpoints., Exploratory (applicable to all study parts except where indicated): Exposure-pharmacodynamic relationship based on MDNA11 serum PK parameters and select markers in the peripheral blood and/or tumor biopsy samples. Dose Escalation/Evaluation (Monotherapy and Combination Therapy): Safety and tolerability will be evaluated with respect to incidence and severity of AEs and SAEs, clinically significant abnormal laboratory parameters, vital signs, and ECG parameters per current CTCAE and incidence of dose limiting toxicities (DLTs)., Dose Escalation/Evaluation (Monotherapy and Combination Therapy): RDE will be evaluated using safety, tolerability, immunological response, PK/PD results and preliminary anti-tumor efficacy data (see secondary objectives)., Dose Expansion (Monotherapy and Combination Therapy): Safety will be evaluated based on incidence, nature and severity of AEs and SAEs, abnormal laboratory parameters, vital signs, and ECG results per CTCAE (currently, v5.0) and incidence of DLTs., Dose Expansion (Monotherapy and Combination Therapy): Assessment by iRECIST and RECIST 1.1: o ORR o CBR o DCR o DOR o TTR o PFS o BOR., Dose Expansion (Monotherapy and Combination Therapy): OS.

Начало: 24.06.2024 Възраст: от 18 г.

Ireland, Poland, Portugal +1 Medicenna Therapeutics Inc. 2023-507536-21-00

Активно (без набиране) Фаза 1

A study to characterize the safety, efficacy, pharmacokinetics of subcutaneous administration of Etentamig (ABBV-383) in patients with relapsed or refractory Multiple Myeloma

Relapsed or Refractory Multiple Myeloma (R/R MM)

Trial status: Authorised

Начало: 13.05.2024 Възраст: от 18 г.

France, Germany AbbVie Deutschland GmbH & Co. KG 2023-507901-32-00

Активно (без набиране) Фаза 3

Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis

multiple sclerosis

Trial status: Authorised Time to onset of composite confirmed disability worsening (cCDW), Time to onset of cCDW, confirmed over 3 months, Time to onset of individual components of the composite, confirmed over 3-months or 6- months, Time to onset of confirmed disability improvement (CDI), Progression independent of relapse activity defined as the time to onset of 6-month cCDW, Total number of new and/or enlarging T2-hyperintense lesions as detected by MRI, Total number of new Gd-enhancing T1-hyperintense lesions per scan as detected by MRI, Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6, Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT), Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time, Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time, Adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, safety scales, and potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG, and vital signs during the study period, Antidrug antibodies (ADAs) over time, Change from baseline in plasma neurofilament light chain (NfL) levels over time, Frexalimab plasma concentration over time Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses

Начало: 26.04.2024 Възраст: 18–64 г.

Austria, Belgium, Bulgaria +15 Sanofi-Aventis Recherche & Developpement 2023-504358-36-00

Активно (без набиране) Фаза 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Participants with Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)

Head and Neck Squamous Cell Carcinoma (HNSCC)

Trial status: Authorised 1. PFS defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) as assessed by the investigator, or death from any cause, whichever occurs first, 2. ORR defined as the percentage of participants who have a complete response (CR) or a partial response (PR) per RECIST v1.1 as assessed by the investigator, 3. DCR defined as the percentage of participants who have achieved a CR, PR, or stable disease (SD) for at least 8 weeks per RECIST v1.1 (as assessed by the investigator), 4. Duration of response (DOR), defined for participants who have a confirmed CR or PR as the time from the date of first documented response (which is subsequently confirmed) per RECIST v1.1, as assessed by the investigator, until date of documented PD or death due to any cause, whichever occurs first, 5. Incidence and severity of adverse events (AEs); Incidence and severity of laboratory abnormalities, 6. Concentrations of ficlatuzumab in serum samples, 7. The presence of antidrug antibodies (ADA) to ficlatuzumab based on seroconversion status, and the evaluation of the potential impact of ADA on PK, efficacy, and safety • The presence of neutralizing antibodies, when ADA is positive, and the evaluation of the potential interference of ADA on ficlatuzumab-HGF binding, 8. Change from baseline in the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-Head and Neck Module 35 (H&N35) • Time to clinically meaningful deterioration in scores on the EORTC H&N35 • Change from baseline in overall health status per the EuroQol-5 dimensions-3 level (EQ-5D-3L) Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause

Начало: 16.04.2024 Възраст: от 18 г.

Belgium, Bulgaria, Czech Republic +8 Aveo Pharmaceuticals Inc. 2023-505606-42-00

Активно (без набиране) Фаза 4

Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial

Septic Shock Sepsis

Trial status: Authorised Number of participants with one or more serious adverse reactions (SARs, defined as anaphylactic shock to IV piperacillin/tazobactam or meropenem, invasive fungal infection, pseudomembranous colitis, or toxic epidermal necrolysis) within 30 days of randomisation, Number of participants with new isolation precautions due to one or more resistant bacteria within 30 days of randomisation, Days alive without life support (i.e., invasive mechanical ventilation, circulatory support, or renal replacement therapy [including days in between intermittent renal replacement therapy]) from randomisation to day 30, Days alive and out of hospital from randomisation to day 30, Days alive without life support (i.e., invasive mechanical ventilation, circulatory support, or renal replacement therapy [including days in between intermittent renal replacement therapy]) from randomisation to day 90, Days alive and out of hospital from randomisation to day 90, All-cause mortality at day 90, All-cause mortality at day 180, HRQoL at day 180 using EQ-5D-5L index values, HRQoL at day 180 using EQ VAS All-cause mortality at day 30 after randomisation

Начало: 10.04.2024 Възраст: от 18 г.

Denmark, Sweden Rigshospitalet 2023-509703-33-00

Активно (без набиране) Фаза 2

An Open label, Safety Clinical trial of (+)-α-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia

Tardive dyskinesia

Trial status: Authorised Incidence of AEs, SAEs, drug-related AEs, severe AEs, AEs leading to discontinuation during the following periods: 1. Overall 2. Titration period 3. Long-term treatment, Observed values and changes in clinical laboratory parameters (haematology, chemistry including prolactin, and urinalysis), Observed values and changes in vital signs, Observed values and changes in ECG parameters and abnormal findings, Observed values and changes in HADS and, C-SSRS., The proportion of subjects who have a treatment success at the end of long-term therapy (Week 54) based on a Clinical Global Impression of Change (CGIC). A treatment success is defined as Much or Very Much Improved on the CGIC at the end of long-term therapy (Week 54)., The proportion of subjects who have ≥3-point reduction in AIMS score from Baseline of this study to the end of long-term therapy (Week 54)., The percent change in AIMS score from Baseline of this study to the end of long-term therapy (Week 54)., The proportion of subjects who have a treatment success at the end of long-term therapy (Week 54) based on a Patient Global Impression of Change (PGIC). A treatment success is defined as Much or Very Much Improved on the PGIC at the end of long-term therapy (Week 54). Change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 through 7) from Baseline of this study to the end of long-term therapy (Week 54), as assessed by the blinded central video rating.

Начало: 03.04.2024 Възраст: от 18 г.

Czech Republic, Poland Adeptio Pharmaceuticals Limited 2023-509518-12-01

Активно (без набиране) Фаза 3

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B-cell Malignancies

B-cell malignancies

Trial status: Authorised Progression-free Survival per investigator assessment, Duration of Response per investigator assessment, Overall Survival The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs.

Начало: 07.03.2024 Възраст: от 18 г.

Czech Republic, France, Germany +6 BeOne Medicines AG 2024-511267-28-00

Активно (без набиране) Фаза 3

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

Juvenile psoriatic arthritis

Trial status: Authorised Change in subject's assessment of pain (a), Number of participants achieving ACR Pedi 20/50/70/90 (a), Change in Childhood Heath Assessment Questionnaire (CHAQ) (a), Change in Juvenile Arthritis Disease Activity Score (JADAS) (a), Refer to protocol for fully list of secondary endpoints., PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a), Number of participants who experience PsA flares (a) Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16

Начало: 07.03.2024

Austria, Belgium, France +9 Amgen Inc. 2023-503435-17-00

Активно (без набиране) Фаза 3

A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome

Childhood Idiopathic Nephrotic Syndrome

Trial status: Authorised 1. Overall relapse-free survival (RFS), 2. Probability of RFS at Week 52, 3. Cumulative corticosteroid dose, 4. Number of relapses, 5. Proportion of participants experiencing edema associated relapse during the 52-week treatment period, 6. Proportion of patients with sustained complete remission at Week 76, 7. Mean change in “General Fatigue” domain of PedsQL-Multidimensional Fatigue scale total score from baseline to Week 52, 8. Mean change in “Physical Functioning” domain of PedsQL-Quality of Life Inventory from baseline to Week 52, 9. Mean change in CureGN Edema Scale from baseline to Week 52, 10. Incidence, nature, and severity of adverse events, with severity determined according to AE intensity (mild, moderate, severe, life-threatening) and NCI CTCAE grading if applicable from baseline to Week 52, 11. Incidence of laboratory or vital sign abnormalities from baseline to Week 52, 12. Serum concentrations of obinutuzumab at specified timepoints, 13. Proportion of participants achieving B-cell depletion (HSFC) at specified timepoints, 14. Total peripheral B cell and B cell subsets (e.g., memory B cells) counts and change from baseline at specified timepoints 1. Percentage of Participants with Sustained Complete Remission at 1 year

Начало: 04.03.2024 Възраст: 18–64 г.

Belgium, France, Germany +3 F. Hoffmann-La Roche AG 2023-505140-19-00

Активно (без набиране) Фаза 4

Evaluation of the omission of dexamethasone in premedication regimens during paclitaxel treatment

Solid tumors

Trial status: Authorised The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);, The severity (grades) of all HSRs as defined by (CTCAE v.5.0);, The percentage (%) of patients that can be rechallenged (according to standard of care procedures) after the occurrence of an HSR with or without dexamethasone;, The number of paclitaxel administrations and cumulative dose (mg) until the first HSR occurrence., The incidence and severity of adverse events related to dexamethasone measured through the validated Dexamethasone Symptom Questionnaire (DSQ)21;, The patient quality of life measured using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scorings tools);, The total cost of treatment of both premedication regimens from a healthcare and societal perspective. The primary outcome is the percentage of patients who experience a clinically relevant HSR (CTCAE grade ≥3) during paclitaxel infusion (Yes/No), determined prospectively by the oncology medical staff (e.g. oncologist).

Начало: 19.02.2024 Възраст: от 18 г.

Netherlands Erasmus Universitair Medisch Centrum Rotterdam (Erasmus 2023-507481-43-00

Активно (без набиране) Фаза 2

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Antitumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Advanced solid tumors

Trial status: Authorised DOR, TTR and CBR, Intracranial tumor response, Central nervous system (CNS) progression-free survival (CNS-PFS) in subjects with measurable brain metastases, PFS and OS, PK parameters, Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities ORR as determined by BICR

Начало: 07.02.2024 Възраст: 18–64 г.

Denmark, France, Italy +1 Turning Point Therapeutics Inc. 2023-506464-14-00

Активно (без набиране) Фаза 2

Multicenter phase 1b/II trial testing neoadjuvant intradermal Ipilimumab and Nivolumab in high risk stage II melanoma –MARIANE

stage II melanoma

Trial status: Authorised

Начало: 05.02.2024 Възраст: от 18 г.

Germany, Netherlands, Sweden Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek 2023-505945-19-00

Активно (без набиране) Фаза 3

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Trial status: Authorised Platelet count at birth in a neonate, Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth

Начало: 23.01.2024 Възраст: 18–64 г.

Belgium, France, Germany +8 Janssen - Cilag International 2023-504307-88-00

Активно (без набиране) Фаза 3

Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

Prostate Cancer

Trial status: Authorised Confidential commercial information

Начало: 12.01.2024 Възраст: от 18 г.

France, Germany, Italy +2 Abx Advanced Biochemical Compounds - Biomedizinische Fo 2023-504026-19-01

Активно (без набиране) Фаза 3

A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis

Dermatitis atopic

Trial status: Authorised Percentage of participants who experienced treatment-emergent serious adverse events (SAEs), Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI), Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24, Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24, Proportion of participants with EASI50/EASI75/EASI90 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24, Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24, Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit], Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit], Proportion of participants with EASI50/ EASI75/EASI90 in all participants entering the study [each LTS17367 visit], Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment, Serum amlitelimab concentration assessed at prespecified time points through the end of the study, Number of participants with anti drug antibodies (ADAs) of amlitelimab at specified timepoints, Percentage of participants who experienced TEAE leading to treatment discontinuation, Proportion of participants with vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit, Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit], Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study, Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA), Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit], Proportion of participants with vIGA-AD score 0 [each LTS17367 visit], Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment, Number of days on topical medication (per patient-year) in all participants entering the study, Change coming from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit], Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit], Change from feeder study baseline^ in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit], Change from feeder study baseline in BSA-AD [each LTS17367 visit], Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA), Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA), Time from LTS17367 baseline to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)., Time from last amlitelimab dose in feeder study to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA). Percentage of participants who experienced treatment-emergent adverse event (TEAE)

Начало: 08.01.2024 Възраст: от 18 г.

Bulgaria, Czech Republic, Denmark +10 Sanofi-Aventis Recherche & Developpement 2023-506548-18-00

Активно (без набиране) Фаза 2

A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild-type AML patients (A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium)

newly diagnosed pediatric FLT3-ITD positive and NPM1 wild-type AML

Trial status: Authorised Efficacy: Other measurements of treatment response: o Proportion of subjects with a complete remission (CR) rate without evidence of MRD after 1 and after 2 induction courses (including CR and remission with incomplete blood count or platelet recovery), Efficacy: Other measurements of treatment response: o Bone marrow blast counts by morphology and MFCM after induction course 1 and induction course 2 and before allo-SCT; CRc (CR and CRi) and morphologic leukemia-free state (MLFS) rates after induction course 1 and 2; MRD negativity (

Начало: 27.12.2023 Възраст: 18–64 г.

Belgium, Denmark, Estonia +9 Prinses Maxima Centrum voor Kinderoncologie B.V. 2023-505000-27-01

Активно (без набиране) Фаза 3

A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma

Melanoma

Trial status: Authorised OS is defined as the time from the date of randomization to death due to any cause PFS is defined as the time from the date of randomization until disease progression assessed by the BIRC per RECIST v1.1 or death due to any cause

Начало: 13.12.2023 Възраст: от 18 г.

Belgium, Czech Republic, Finland +9 Iovance Biotherapeutics Inc. 2022-503140-41-00

Активно (без набиране) Фаза 3

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy

Moderate to Severe Active Systemic Lupus Erythematosus

Trial status: Authorised SRI(4) responders at Wk. 52 (Y/N): meet all the following: Minimum 4-point reduction from baseline (BL) SLEDAI2K score No new BILAG-2004 (BILAG) scores from BL (≥ 1 new A or ≥ 2 new BILAG B scores) No worsening in BL lupus disease activity (increase ≥ 0.30 points on a PGA 3-point VAS), Time to first flare through Week 52, where flare is defined as either ≥ 1 new BILAG-2004 A, or ≥ 2 new BILAG-2004 B items compared with the previous visit., • PK: Anifrolumab serum concentrations • Immunogenicity: ADA • PD: Change from baseline through Week 52 in: o Anti-dsDNA antibodies o C3, C4, and CH50 complement levels o Type I IFN 21-gene signature, Participants who are PRINTO/ACR cSLE responders (Y/N) at W52, defined as at least 50% improvement from baseline in any 2 of 5 core set outcome measures and no more than one of the remaining worsening > 30%, Reduction of OCS background dose from baseline through Week 52 After single dose or after dose adjustment: • Serum PK concentrations PK parameters: Cmax, AUC, Cmin after the first dose or after dose adjustment, BICLA responders at W52 (Y/N), defined as follow: Reduction of all baseline BILAG A to B/C/D & B to C/D & no BILAG worsening in other organ systems (≥ 1 new BILAG A or ≥ 2 new BILAG B) No worsening from baseline S-2K (increase of > 0 points) No worsening from baseline in SLE activity (increase ≥ 0.30 points on a PGA 3-point VAS)

Начало: 06.11.2023

France, Germany, Italy +3 AstraZeneca AB 2022-502289-25-00

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