Trials with a site in Sofia, Bulgaria

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.

NCT04516447 · Official ClinicalTrials.gov record · K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

This study wants to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.

NCT04638647 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This study wants to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to dummy treatment (placebo). Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.

NCT05222529 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This is a Phase 3, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the clinical how well it works, safety, and tolerability of XEN1101 administered as added on top of your current treatment treatment in primary generalized tonic-clonic seizures (PGTCS).

NCT05667142 · Official ClinicalTrials.gov record · Xenon Pharmaceuticals Inc.

The X-TOLE3 Phase 3 clinical trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study that will measure the clinical how well it works, whether it is safe and how hard side effects are to live with of XEN1101 administered as added on top of your current treatment therapy in focal-onset seizures.

NCT05716100 · Official ClinicalTrials.gov record · Xenon Pharmaceuticals Inc.

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

NCT05920356 · Official ClinicalTrials.gov record · Amgen

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, how well it works, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies.

NCT05995353 · Official ClinicalTrials.gov record · AbbVie

This study wants to evaluate long-term whether it is safe and how hard side effects are to live with of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

NCT06133972 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate how well it works and dose response of ACP-204 30 and 60 mg vs dummy treatment (placebo). * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs dummy treatment (placebo).

NCT06159673 · Official ClinicalTrials.gov record · ACADIA Pharmaceuticals Inc.

This is a Phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter study to measure the how well it works and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

NCT06226883 · Official ClinicalTrials.gov record · Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. this study wants to measure the how well it works and safety of TAK-279 versus dummy treatment (placebo) in participants with moderately to severely active Crohn's disease (CD).

NCT06233461 · Official ClinicalTrials.gov record · Takeda

The overall objective of the RESTORATiVE303 study is to measure the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching dummy treatment (placebo). The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

NCT06237452 · Official ClinicalTrials.gov record · Vedanta Biosciences, Inc.

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

NCT06252649 · Official ClinicalTrials.gov record · Amgen

This is a Phase III, international, multi-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to measure the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

NCT06307652 · Official ClinicalTrials.gov record · AstraZeneca

The study will assess the how well it works and safety of 2 dose regimens of pegozafermin compared to dummy treatment (placebo) for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

NCT06318169 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This is a study evaluating the how well it works and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis: Combination of calderasib and pembrolizumab is superior to dummy treatment (placebo) plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

NCT06345729 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

The primary objective of the study is to measure how well it works of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer

NCT06380751 · Official ClinicalTrials.gov record · AstraZeneca

The study will assess the how well it works and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

NCT06419374 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more.

NCT06424288 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) as added on top of your current treatment therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

NCT06480383 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs.

NCT06499285 · Official ClinicalTrials.gov record · Takeda

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, compared with a dummy treatment, flexible-dose study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) in the treatment of psychosis in patients with AD.

NCT06540833 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss.

NCT06548542 · Official ClinicalTrials.gov record · AbbVie

This study wants to measure the safety and how well it works of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

NCT06585787 · Official ClinicalTrials.gov record · Karuna Therapeutics, Inc., a Bristol Myers Squibb company

The Phase 1 study described herein will measure the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

NCT06619990 · Official ClinicalTrials.gov record · Xencor, Inc.

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. this study wants to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.

NCT06632444 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * body-mass index (BMI) of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study.

NCT06632457 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, flexible-dose study of the how well it works, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.

NCT06651567 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.

NCT06671483 · Official ClinicalTrials.gov record · Takeda

The study will measure the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the whether it is safe and how hard side effects are to live with of ocrelizumab. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.

NCT06675955 · Official ClinicalTrials.gov record · Hoffmann-La Roche

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments.

NCT06677060 · Official ClinicalTrials.gov record · AstraZeneca

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to assess the how well it works, safety, and tolerability of ITI-1284 as this drug alone treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

NCT06701903 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

International, Multicenter, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment and Event-driven study to assess how well it works, whether it is safe and how hard side effects are to live with of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

NCT06742723 · Official ClinicalTrials.gov record · AstraZeneca

This is a Phase 3, open-label, randomly assigned, clinical trial evaluating the how well it works and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

NCT06757634 · Official ClinicalTrials.gov record · Celcuity Inc

Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake.

NCT06764693 · Official ClinicalTrials.gov record · AbbVie

This clinical trial is designed to measure the how well it works and safety of T-DXd in combination with bevacizumab versus bevacizumab this drug alone as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

NCT06819007 · Official ClinicalTrials.gov record · Daiichi Sankyo

A Multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, Parallel Group, Phase 3 Study to measure the how well it works and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT06878261 · Official ClinicalTrials.gov record · AstraZeneca

This is 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 (BP-I) The primary objective of the study is to measure the long-term whether it is safe and how hard side effects are to live with of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

NCT06929273 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study.

NCT06935370 · Official ClinicalTrials.gov record · Boehringer Ingelheim

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected.

NCT06977581 · Official ClinicalTrials.gov record · Pfizer

Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. this study wants to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).

NCT07007065 · Official ClinicalTrials.gov record · AbbVie

This study wants to measure the how well it works and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

NCT07011732 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.

NCT07015905 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure.

NCT07064473 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This Phase 3 study is evaluating the safety and how well it works of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD). Enrollment in the primary global cohort has been completed; Study centers in Japan remain open for enrollment for the Japan cohort.

NCT07064759 · Official ClinicalTrials.gov record · 4D Molecular Therapeutics

This is a randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, this drug alone study to measure the how well it works, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (major depression), with or without anxious distress.

NCT07065240 · Official ClinicalTrials.gov record · Seaport Therapeutics

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with PPMS.

NCT07067463 · Official ClinicalTrials.gov record · Zenas BioPharma (USA), LLC

The main purpose of this study is to demonstrate the how well it works and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or dummy treatment (placebo) for 24 weeks (6 months).

NCT07091630 · Official ClinicalTrials.gov record · argenx

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer.

NCT07099898 · Official ClinicalTrials.gov record · GlaxoSmithKline

A study to measure the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

NCT07116967 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO.

NCT07165028 · Official ClinicalTrials.gov record · Eli Lilly and Company

This study wants to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.

NCT07216027 · Official ClinicalTrials.gov record · Pfizer

This study wants to measure cardiovascular outcomes with orforglipron compared with dummy treatment (placebo) in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

NCT07241390 · Official ClinicalTrials.gov record · Eli Lilly and Company

The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.

NCT07276724 · Official ClinicalTrials.gov record · Generate Biomedicines

This is a non-treatment, multi-country, multi-centre, multicohort, primary data collection study, designed to assess patients' reported satisfaction with Atezolizumab Subcutenous (SC) treatment and Health-related Quality of Life (HRQoL), as well as the effectiveness and safety of Atezolizumab SC in participants treated for selected approved indications in routine clinical practice.

NCT07284121 · Official ClinicalTrials.gov record · Hoffmann-La Roche

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with non-active Secondary Progress MS.

NCT07299019 · Official ClinicalTrials.gov record · Zenas BioPharma (USA), LLC

The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.

NCT07332481 · Official ClinicalTrials.gov record · EMD Serono Research & Development Institute, Inc.

The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.

NCT07355218 · Official ClinicalTrials.gov record · EMD Serono Research & Development Institute, Inc.

This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study.

NCT07361302 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This study is open to adults with systemic lupus erythematosus (SLE). this study wants to find out whether a medicine called BI 3000202 helps people with SLE.

NCT07409181 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This study wants to evaluate how well nipocalimab works as compared to dummy treatment (placebo) in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

NCT07438496 · Official ClinicalTrials.gov record · Janssen Research & Development, LLC

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

NCT07441642 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This is a Phase 1, first in human study to measure the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to dummy treatment (placebo) in participants with Rheumatoid Arthritis

NCT07533955 · Official ClinicalTrials.gov record · Jade Biosciences, Inc.

This study wants to assess how well JNJ-78934804 works (how well it works) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

NCT07577856 · Official ClinicalTrials.gov record · Janssen Research & Development, LLC

This study wants to measure the how well it works, whether it is safe and how hard side effects are to live with of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from treatment trials.

NCT07624305 · Official ClinicalTrials.gov record · AstraZeneca

This study wants to measure the how well it works, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

NCT07662213 · Official ClinicalTrials.gov record · AstraZeneca

This study wants to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring whether it is safe and how hard side effects are to live with. Study details include: * Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study.

NCT07691970 · Official ClinicalTrials.gov record · AstraZeneca

This study will measure the how well it works, whether it is safe and how hard side effects are to live with of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab this drug alone as first line maintenance treatment in patients with non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer.

NCT07851025 · Official ClinicalTrials.gov record · AstraZeneca