Clinical trials: in Hungary
KRAS p.G12C Mutant Advanced Solid Tumors
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS…
- Trial name
- NCT03600883
- Testing
- sotorasib, Anti PD-1/L1, Midazolam
- Where
- 133 sites in United States, Australia and 14 more
- Volunteers
- 713 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus, SLE
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
- Trial name
- NCT06335979
- Testing
- PIT565
- Where
- 11 sites in China, Germany and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
- Trial name
- KALOS (NCT04609878)
- Testing
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg
- Where
- 360 sites in United States, Argentina and 19 more
- Volunteers
- 2,274 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
- Trial name
- NCT07029555
- Testing
- PIT565
- Where
- 16 sites in Argentina, Bulgaria and 7 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Angioedema (HAE)
A Study of Navenibart in Participants With Hereditary Angioedema
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2…
- Trial name
- ALPHA-ORBIT (NCT06842823)
- Testing
- navenibart
- Where
- 86 sites in United States, Australia and 22 more
- Volunteers
- 157 people
- Sponsor
- Astria Therapeutics, Inc.
Urinary Bladder Cancer, Muscle-invasive
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
- Trial name
- NCT03924895
- Testing
- Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin
- Where
- 242 sites in United States, Argentina and 26 more
- Volunteers
- 595 people
- Sponsor
- Merck Sharp & Dohme LLC
Myelodysplastic Syndromes
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are…
- Trial name
- ELEMENT-MDS (NCT05949684)
- Testing
- Luspatercept, Epoetin Alfa
- Where
- 144 sites in United States, Argentina and 17 more
- Volunteers
- 402 people
- Sponsor
- Bristol-Myers Squibb
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.
- Trial name
- NCT04994717
- Testing
- Blinatumomab, Low-intensity chemotherapy regimen, SOC chemotherapy regimen
- Where
- 192 sites in United States, Australia and 30 more
- Volunteers
- 303 people
- Sponsor
- Amgen
Non-Small Cell Lung Cancer
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
- Trial name
- NCT04248829
- Testing
- Lazertinib 240 mg/160 mg, Gefitinib 250 mg
- Where
- 80 sites in Australia, Greece and 11 more
- Volunteers
- 393 people
- Sponsor
- Yuhan Corporation
Chronic Hepatitis D Infection
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection.
- Trial name
- NCT07298330
- Testing
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- Where
- 27 sites in United States, Belgium and 8 more
- Volunteers
- 80 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
Cenobamate Open-Label Extension Study for YKP3089C025
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
- Trial name
- NCT03961568
- Testing
- Cenobamate
- Where
- 45 sites in United States, Bulgaria and 5 more
- Volunteers
- 147 people
- Sponsor
- SK Life Science, Inc.
Early Alzheimer´s Disease
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study…
- Trial name
- EVOKE Plus (NCT04777409)
- Testing
- Semaglutide
- Where
- 498 sites in United States, Argentina and 36 more
- Volunteers
- 1,840 people
- Sponsor
- Novo Nordisk A/S
Asthma
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Evaluate the superiority of CHF 5993 200/6/12.5 µg pressurised metered dose inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg…
- Trial name
- TRIGGER (NCT02676089)
- Testing
- CHF 5993 200/6/12.5 µg, CHF 1535 200/6 µg, CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
- Where
- 244 sites in Argentina, Belarus and 15 more
- Volunteers
- 1,437 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Carcinoma, Non-Small-Cell Lung
KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been…
- Trial name
- NCT04165096
- Testing
- Pembrolizumab, Boserolimab, MK-4830
- Where
- 39 sites in United States, Hungary and 5 more
- Volunteers
- 128 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease and Hypertension
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.
- Trial name
- NCT06268873
- Testing
- Baxdrostat/dapagliflozin
- Where
- 565 sites in United States, Argentina and 36 more
- Volunteers
- 2,554 people
- Sponsor
- AstraZeneca
Asthma
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant.
- Trial name
- TRECONY (NCT07301736)
- Testing
- CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, CHF718 pMDI with HFA-134a
- Where
- 167 sites in Argentina, Bosnia and Herzegovina and 12 more
- Volunteers
- 780 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
B-Cell Malignancies
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of…
- Trial name
- NCT04509700
- Testing
- Parsaclisib, parsaclisib + itacitinib, parsaclisib + ruxolitinib
- Where
- 105 sites in United States, Austria and 15 more
- Volunteers
- 112 people
- Sponsor
- Incyte Corporation
Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
The primary objectives of the study are: To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell…
- Conditions
- Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer
- Trial name
- NCT03088540
- Testing
- Pemetrexed, Paclitaxel, Gemcitabine
- Where
- 192 sites in Australia, Belarus and 22 more
- Volunteers
- 712 people
- Sponsor
- Regeneron Pharmaceuticals
Moderate-to-Severe Atopic Dermatitis
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT04921345
- Testing
- Nemolizumab
- Where
- 23 sites in United States, Denmark and 3 more
- Volunteers
- 109 people
- Sponsor
- Galderma R&D
Coronary Heart Disease (CHD)
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a…
- Trial name
- VESALIUS-CV (NCT03872401)
- Testing
- Evolocumab
- Where
- 852 sites in United States, Argentina and 31 more
- Volunteers
- 12,301 people
- Sponsor
- Amgen
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