Search trials – HealthDB

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Намерени 282 изпитвания Стр. 11 от 15

Active (not recruiting) Phase 3

A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

Stage IB-IIIA NSCLC Patients with uncommon EGFR Mutations

Trial status: Authorised Disease-free survival (DFS) by investigator assessment

Начало: 06.10.2025 Възраст: от 18 г.

Belgium, France, Germany +6 Taiho Oncology Inc. 2025-521775-31-00

Active (not recruiting) Phase 3

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2-overexpressing and PD-L1 TPS

Unresectable or Metastatic HER2 overexpressing and PD-L1 TPS

Trial status: Authorised Overall Survival (OS). OS is defined as the time interval from the date of randomization to the date of death due to any cause. Progression-free survival (PFS) by BICR. PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.

Начало: 06.10.2025 Възраст: от 18 г.

Belgium, France, Germany +6 Daiichi Sankyo Inc. 2024-515658-26-00

Active (not recruiting) Phase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis (RENEW)

Idiopathic Pulmonary Fibrosis

Trial status: Authorised Change from baseline through 24 weeks in forced vital capacity (FVC) in mL., Change from baseline through 24 weeks in percent predicted forced vital capacity (ppFVC)., Change from baseline at 24 weeks in lung fibrosis measured by high resolution computed tomography (HRCT)., Exploratory Endpoint: Change from baseline through 24 weeks in the Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnea and cough domains., Exploratory Endpoint: Time to all-cause respiratory hospitalization lung transplantation, or death through 28 weeks., Exploratory Endpoint: Change from baseline through 24 weeks for biomarkers related to the pathophysiology of IPF. The incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24.

Начало: 06.10.2025 Възраст: от 18 г.

Germany, Poland Rein Therapeutics Inc. 2025-520715-13-00

Active (not recruiting) Phase 2

A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)

Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Trial status: Authorised ORR with PR-L as assessed by IRC, DOR as assessed by IRC and by investigator, PFS as assessed by IRC and by investigator, Complete response rate as assessed by IRC and by investigator, TTR as assessed by IRC and by investigator, OS, Including, but not limited to, incidence and severity of TEAEs, SAEs and TEAEs leading to study drug discontinuation, Changes from baseline in laboratory parameters and vital signs, Summary measures of PK trough concentrations, ORR (with and without PR-L) as assessed by investigator, PROs measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires ORR (without PR-L) as assessed by IRC

Начало: 02.10.2025 Възраст: от 18 г.

France, Hungary, Italy +1 Nurix Therapeutics Inc. 2025-521088-10-00

Active (not recruiting) Phase 3

A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicenter Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)

Advanced Hepatocellular Carcinoma

Trial status: Authorised PFS, ORR, DoR by BICR per RECIST v1.1 Overall Survival (OS)

Начало: 30.09.2025 Възраст: от 18 г.

France, Germany, Italy +3 AstraZeneca AB 2024-518210-81-00

Active (not recruiting) Phase 4

A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease (AEOLUS)

Respiratory tract diseases

Trial status: Authorised Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)

Начало: 29.09.2025 Възраст: от 18 г.

Austria, Denmark, France +7 Sanofi-Aventis Recherche & Developpement 2025-521268-37-00

Active (not recruiting) Phase 1

A Phase I Study of BMS-986497 alone or in combination with Azacitidine (Aza) and Azacitidine plus Venetoclax (AZA+VEN) in relapsed or refractory (R/R) AML or MDS

Acute Myeloid Leukemia and Myelodysplastic Syndrome

Trial status: Authorised

Начало: 26.09.2025 Възраст: от 18 г.

France, Spain Bristol-Myers Squibb Services Unlimited Company 2024-519537-29-00

Active (not recruiting) Phase 3

ARGX-113-2409: A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo- Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants from 12 Years to Less Than 18 Years of Age with Chronic ITP

Chronic Idiopathic thrombocytopenic purpura

Trial status: Authorised 1) Efgartigimod serum concentrations over time during the DBTP, 2) Percent change from baseline in total IgG levels in serum over time during the DBTP, 3) Incidence, severity, and relatedness of the IMP to AEs, SAEs, and AEs leading to IMP discontinuation, 4) Clinically significant changes in laboratory parameters, ECGs, and vital signs, 5) Sustained platelet count response, defined as achieving platelet counts of ≥50 × 109/L for at least 4 of the 6 study visits between study weeks 19 and 24 of the DBTP and in OLTP1 for participants receiving placebo in the DBTP, 6) Extent of disease control, defined as the number of cumulative weeks with a platelet count of ≥50 × 109/L during the DBTP and the first 24 weeks of OLTP1 for participants receiving placebo in the DBTP, 7) Actual values and changes from baseline for platelet counts over time, 8) Incidence and severity of bleeding, assessed by the Modified Buchanan and Adix Bleeding Score for pediatric ITP15, 9) Incidence and prevalence of ADA and NAb against efgartigimod in serum, 10) Change from baseline in: − EQ-5D-5L − KIT Child Self-Report and KIT Parent Impact Report − pedsFACIT-F, 11) Measurement of immature platelet fractions (IPF#and IPF%) in blood samples over time 1) Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of clearance and volume of distribution of efgartigimod IV in the DBTP, 2) Total IgG levels as input for PK/PD modeling analysis in the DBTP

Начало: 24.09.2025

France, Germany, Hungary +5 Argenx 2025-521055-23-00

Active (not recruiting) Phase 4

Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE)

acute ischemic stroke and atrial fibrillation (AF)

Trial status: Authorised Each of the components of the primary outcome (each analysed as time to first event): recurrent ischemic stroke, haemor-rhagic stroke, unclassified stroke, cardiovascular death, hospitalization due to worsening of heart failure, and hospitalization due to ACS, Recurrent disabling stroke (as time to first event), Recurrent AF (as time to first event), Cardiac rhythm (sinus rhythm vs. AF) at 12 and 24 months, Unplanned cardiovascular hospitalization (as time to first hospitalization), Number of cardiovascular hospitalizations, Change from baseline in left ventricular function (left ventricular ejection fraction [LVEF]) at 24 months, Functional status assessed with the modified Rankin Scale (mRS) at 12 and 24 months, Quality of life assessed with the EuroQol five-dimensional questionnaire (EQ-5D) and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) domains on physical and mental health at 12 and 24 months, Cognitive function assessed with the Montreal Cognitive Assessment (MoCA) at 12 and 24 months, Cost of therapy A composite of first recurrent ischaemic stroke, haemorrhagic stroke, unclassified stroke, cardiovascular death, or hospitaliza-tion due to worsening of heart failure or due to acute coronary syndrome (ACS), analysed as time to the first occurrence of one of the aforementioned components.

Начало: 11.09.2025 Възраст: от 18 г.

Germany, Netherlands, Spain University Medical Center Hamburg-Eppendorf 2025-521260-35-00

Active (not recruiting) Phase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

BP-I mania or mania with mixed features

Trial status: Authorised Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3., Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period., Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3. Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.

Начало: 28.08.2025 Възраст: 18–64 г.

Croatia, Romania, Slovakia +2 Bristol-Myers Squibb Services Unlimited Company 2024-520195-94-00

Active (not recruiting) Phase 2

An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study

Relapsed / Refractory Metastatic or Advanced Solid Tumors Myelofibrosis Relapsed or Refractory High-Risk Myelodysplastic Syndrome Acute Myeloid Leukemia with or without NPM1 Mutation

Trial status: Authorised Time from the first administration of RVU120-based treatment in the parent study until discontinuation of RVU120-based treatment for any reason in the rollover study Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Начало: 27.08.2025 Възраст: от 18 г.

France, Italy, Poland +1 Ryvu Therapeutics S.A. 2025-521673-14-00

Active (not recruiting) Phase 3

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania with Mixed Features in Bipolar-I Disorder (BALSAM-3)

Mania or Mania with Mixed Features in Bipolar-I Disorder

Trial status: Authorised To monitor for: serious side effects, specific side effects of concern, side effects that cause participants to stop treatment., To observe any changes in how participants respond to questions about suicidal thoughts or behaviors., To measure changes from the beginning of the study in: Movement and coordination (using tests like BARS, SAS, and AIMS); Urinary symptoms (for male participants aged 45 and older, using the IPSS questionnaire). To track any side effects that participants experience while receiving the treatment.

Начало: 26.08.2025 Възраст: от 18 г.

Bulgaria, Croatia, Hungary +5 Bristol-Myers Squibb Services Unlimited Company 2024-520259-26-00

Active (not recruiting) Phase 3

A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Hidradenitis Suppurativa // Prurigo Nodularis // Vitiligo

Trial status: Authorised For HS indication: ANdT count of 0-2 at each visit, For vitiligo indication: Change from baseline of the initial parent study (INCB 54707-303 or INCB 54707-304) in F-VASI score at each visit, For vitiligo indication: Change from baseline of the initial parent study (INCB 54707-303 or INCB 54707-304) in T-VASI score at each visit, For PN indication: Itch NRS score of 0 or 1 at each visit, For PN indication: IGA-CPG-S score of 0 or 1 at each visit TEAEs reported in participants receiving povorcitinib

Начало: 26.08.2025 Възраст: от 18 г.

Austria, Belgium, Bulgaria +10 Incyte Corp. 2024-520107-12-00

Active (not recruiting) Phase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse 022/ENGOT ov84/GOG-3103)

Ovarian cancer recurrent

Trial status: Authorised Part 2: Overall Survival (OS), Part 2: Number of Participants with One or More AEs, Part 2: Number of Participants who Discontinue Study Intervention Due to an AE, Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score, Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score, Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 Abdominal/Gastrointestinal Symptom Scale Part 1: Number of Participants with One or More Adverse Events (AE), Part 1: Number of Participants who Discontinue Study Intervention Due to an AE, Part 2: Progression-free Survival (PFS)

Начало: 22.08.2025 Възраст: от 18 г.

Austria, Belgium, Czech Republic +11 Merck Sharp & Dohme LLC 2023-508015-23-00

Active (not recruiting) Phase 2

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults with Major Depressive Disorder (MDD), with or without Anxious Distress

Major Depressive Disorder (MDD) with or without Anxious Distress

Trial status: Authorised Change from Baseline to Visit 6 (Study Day 42) in Clinician Global Impression-Severity (CGI-S) Change from Baseline to Visit 6 (Study Day 42) in Hamilton Depression Rating Scale-17 (HAM-D-17) total score

Начало: 04.08.2025 Възраст: от 18 г.

Bulgaria, Czech Republic, Germany +4 Seaport Therapeutics Inc. 2025-521240-37-00

Active (not recruiting) Phase 3

A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2.5 mg administered once daily for up to 76 weeks in patients with bronchiectasis (The AIRTIVITY TM Study)

Bronchiectasis

Trial status: Authorised Absolute change from baseline in post-bronchodilator FEV1 %pred at Week 52, Absolute change from baseline in QOL-B respiratory symptoms domain score at Week 52 (participants ≥16 years), Time to first adjudicated pulmonary exacerbation up to Week 76, Absolute change from baseline in post-bronchodilator FVC %pred at Week 52, Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76, Time to first severe adjudicated pulmonary exacerbation up to Week 76 Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76.

Начало: 31.07.2025 Възраст: от 18 г.

Austria, Belgium, Bulgaria +19 Boehringer Ingelheim International GmbH, Boehringer Ing 2024-518589-29-00

Active (not recruiting) Phase 1

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

Follicular lymphoma (FL) Chronic lymphocytic leukemia (CLL) Diffuse large b-cell lymphoma (DLBCL) B-cell malignancies

Trial status: Authorised

Начало: 14.07.2025 Възраст: от 18 г.

France, Italy, Spain AbbVie Deutschland GmbH & Co. KG 2023-505479-56-00

Active (not recruiting) Phase 3

A Phase 3b Open-Label Study of Long-Term Neurocognitive Outcomes in Children With Phenylketonuria Treated With Sepiapterin (EPIPHENY)

Phenylketonuria

Trial status: Authorised 01. Change from baseline in phenylketonuriaquality of life (PKU-QOL) questionnaire score over time, 02. Change from baseline in European Quality of Life - 5 Dimensions (EQ-5D) score over time, 03. Mean change in FSIQ (WPPSI-IV or WISC-V) over a 4-year period, 04. Change of phenylalanine (Phe) levels over time Mean change in full-scale intelligence quotient (FSIQ) (WPPSI-IV or WISC-V) over a 2-year period: WPPSI-IV (Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition): for participants ≥30 months to

Начало: 14.07.2025

France, Ireland, Poland +1 PTC Therapeutics Inc. 2024-514435-20-00

Active (not recruiting) Phase 3

A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2ARearrangements or NPM1Mutations who are Ineligible for Intensive Chemotherapy

Acute Myeloid Luekemia

Trial status: Authorised Dual primary endpoints: CR and OS

Начало: 11.07.2025 Възраст: от 18 г.

Austria, Belgium, Czech Republic +9 Janssen Cilag International 2024-520154-38-00

Active (not recruiting) Phase 1

A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren’s Disease

Sjogren's Disease

Trial status: Authorised

Начало: 04.07.2025 Възраст: от 18 г.

France, Germany, Italy +1 Cullinan Therapeutics Inc. 2025-521462-96-00

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