Clinical trials: sponsored by Novartis Pharmaceuticals
Metastatic Prostate Cancer
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer
- Trial name
- PULSE (NCT07484269)
- Where
- Switzerland
- Volunteers
- 753 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
This study aims to evaluate the various aspects of treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings.
- Trial name
- PRISM (NCT07697989)
- Where
- United States
- Volunteers
- 1,085 people
- Sponsor
- Novartis Pharmaceuticals
Acute Coronary Syndrome
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome.
- Trial name
- NCT07684469
- Testing
- inclisiran, SOC
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
CNS Tumors, Meningioma
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
The study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma…
- Conditions
- CNS Tumors, Meningioma, Esthesioneuroblastoma, Hemangioblastoma
- Trial name
- DOMINO-START (NCT04081701)
- Testing
- Ga68-DOTATATE-PET/MRI
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Weill Medical College of Cornell University
Cancer
Pan Tumor Rollover Study
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
- Trial name
- NCT03899155
- Testing
- Nivolumab, Ipilimumab, Cabozantinib
- Where
- 410 sites in United States, Argentina and 36 more
- Volunteers
- 1,500 people
- Sponsor
- Bristol-Myers Squibb
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Renal Angiomyolipoma
A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
The purpose of this prospective study is to assess the safety and efficacy of everolimus in Taiwanese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) .
- Trial name
- NCT05252585
- Testing
- Everolimus
- Where
- 4 sites in Taiwan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323).
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia
- Trial name
- NCT03960840
- Testing
- Rapcabtagene autoleucel single agent, Ibrutinib
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 218 people
- Sponsor
- Novartis Pharmaceuticals
Advanced HR+/HER2- Breast Cancer
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone…
- Trial name
- NCT07604571
- Testing
- IEV407, Fulvestrant, Letrozole
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)
The primary purpose is to address critical evidence in the treatment landscape for Spinal Muscular Atrophy (SMA), specifically focusing on the intrathecal formulation of onasemnogene abeparvovec-brve (ITVISMA®). U.S.
- Trial name
- NCT07448610
- Testing
- Onasemnogene Abeparvovec-brve
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer
Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer
This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan.
- Trial name
- NCT07093801
- Where
- 35 sites in Italy
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
GIST and CML
Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator
This Phase IV, open-label, multicenter roll-over study evaluated the long-term safety of imatinib in patients who had completed a previous Novartis-sponsored imatinib study and were considered by the investigator to continue…
- Trial name
- NCT01742299
- Testing
- imatinib mesylate
- Where
- 29 sites in United States, China and 9 more
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization.
- Trial name
- V-INTERVENTION (NCT06909565)
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 149 sites in United States
- Volunteers
- 6,000 people
- Sponsor
- Duke University
Sjögren's Disease
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection…
- Trial name
- NCT07737743
- Testing
- DDY391
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 344 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.
- Trial name
- KRONOS (NCT05776888)
- Testing
- Ofatumumab
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Pruritus of Unknown Origin
A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).
- Trial name
- NCT07811869
- Testing
- Remibrutinib
- Where
- 10 sites in United States, Canada
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation
The study aimed to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation.
- Trial name
- MS-PEKOS (NCT06668324)
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation
A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with…
- Trial name
- NCT07217067
- Testing
- PKN605
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 165 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region.
- Trial name
- ASC4Young (NCT07681258)
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune and Chronic Inflammatory Diseases
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.
The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.
- Trial name
- NCT07032272
- Testing
- remibrutinib
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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