Clinical trials: sponsored by Novartis Pharmaceuticals
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP.
- Trial name
- NCT04971226
- Testing
- Imatinib, Nilotinib, Bosutinib
- Where
- 110 sites in United States, Australia and 27 more
- Volunteers
- 405 people
- Sponsor
- Novartis Pharmaceuticals
Cardiovascular Disease and Lipoprotein(a)
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
- Trial name
- Lp(a)HORIZON (NCT04023552)
- Testing
- TQJ230
- Where
- 902 sites in United States, Argentina and 41 more
- Volunteers
- 8,323 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Non-small Cell Lung Cancer (NSCLC)
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of [177Lu]Lu-DWJ155 and the safety and imaging properties of [68Ga]Ga-DWJ155 in patients with…
- Conditions
- Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Gastric/Gastroesophageal Junction (GEJ) Cancer, Bladder Cancer
- Trial name
- NCT07660055
- Testing
- [68Ga]Ga-DWJ155, [177Lu]Lu-DWJ155
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC)
Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors
The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DFC413, and in Part 2 compare to [68Ga]Ga-NNS309 in patients with locally advanced or…
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC), HR+/HER2- Ductal Breast Cancer (BC), HR+/HER2- Lobular Breast Cancer (BC)
- Trial name
- NCT07630961
- Testing
- 68Ga-DFC413, 68Ga-NNS309
- Where
- 2 sites in Denmark, Japan
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
Diffuse Astrocytoma, Anaplastic Astrocytoma
Pediatric Long-Term Follow-up and Rollover Study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
- Trial name
- NCT03975829
- Testing
- dabrafenib, trametinib
- Where
- 54 sites in United States, Argentina and 17 more
- Volunteers
- 163 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative…
- Trial name
- NCT07117214
- Testing
- [68Ga]Ga-DWJ155
- Where
- Netherlands
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with…
- Trial name
- ASC4START (NCT05456191)
- Testing
- Asciminib, Nilotinib
- Where
- 119 sites in United States, Argentina and 22 more
- Volunteers
- 568 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
This study was planned as a prospective multicenter NIS. This study was observational in nature and did not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule.
- Trial name
- PROSPERITY (NCT04943497)
- Testing
- ribociclib, aplelicib, mono endocrine therapy
- Where
- 57 sites in Russia
- Volunteers
- 2,390 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
- Trial name
- VICTORION-2P (NCT05030428)
- Testing
- Inclisiran sodium 300 mg
- Where
- 983 sites in United States, Argentina and 48 more
- Volunteers
- 17,004 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens…
- Trial name
- NCT04179175
- Testing
- secukinumab
- Where
- 191 sites in United States, Argentina and 36 more
- Volunteers
- 702 people
- Sponsor
- Novartis Pharmaceuticals
Tuberous Sclerosis Complex
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be…
- Trial name
- NCT02962414
- Testing
- everolimus
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice
This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US).
- Trial name
- NCT07779460
- Where
- United States
- Volunteers
- 7,466 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with…
- Trial name
- VAYHIT2 (NCT05653219)
- Testing
- Ianalumab, Eltrombopag
- Where
- 74 sites in United States, Argentina and 22 more
- Volunteers
- 152 people
- Sponsor
- Novartis Pharmaceuticals
B-Cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD…
- Trial name
- CASSIOPEIA (NCT03876769)
- Testing
- CTL019
- Where
- 43 sites in United States, Belgium and 9 more
- Volunteers
- 121 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Kidney Disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
- Trial name
- NCT07235059
- Testing
- OJR520
- Where
- 2 sites in United States, Germany
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Extensive Stage Small Cell Lung Cancer
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment…
- Trial name
- NCT05142696
- Testing
- [177Lu]Lu-DOTA-TATE, Atezolizumab, [68Ga]Ga-DOTA-TATE
- Where
- 27 sites in United States, Austria and 10 more
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, Diffuse Large B Cell Lymphoma
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy…
- Conditions
- Advanced Solid Tumor, Diffuse Large B Cell Lymphoma, Lymphoma, T-Cell, Mesothelioma, Malignant
- Trial name
- NCT04104776
- Testing
- Tulmimetostat, Enzalutamide
- Where
- 80 sites in United States, France and 5 more
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo.
- Trial name
- NCT05222529
- Testing
- Glycopyrronium bromide 25ug, Glycopyrronium bromide 12.5ug
- Where
- 23 sites in Bulgaria, Colombia and 6 more
- Volunteers
- 42 people
- Sponsor
- Novartis Pharmaceuticals
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