Clinical trials: recruiting, sponsored by Novartis Pharmaceuticals
Secondary Malignancies of T-cell Origin
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
The study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after…
- Trial name
- Lythesia (NCT07378969)
- Where
- 4 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Berger Disease, Bergers Disease
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to <18 years with primary immunoglobulin A nephropathy (IgAN).
- Conditions
- Berger Disease, Bergers Disease, IgA Nephropathy, Immunoglobulin A Nephropathy
- Trial name
- ADVANCE (NCT07498335)
- Testing
- Drug: Atrasentan
- Where
- 23 sites in United States, China and 6 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF)…
- Conditions
- Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF)
- Trial name
- MANIFEST-3 (NCT07357727)
- Testing
- Pelabresib, Ruxolitinib
- Where
- 164 sites in United States, Argentina and 20 more
- Volunteers
- 460 people
- Sponsor
- 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
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who…
- Trial name
- VAY2EXPLORE (NCT07421167)
- Testing
- ianalumab, thrombopoietin receptor agonist (TPO-RA)
- Where
- 23 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
C3G
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
- Trial name
- APPEAR-C3G (NCT04817618)
- Testing
- iptacopan
- Where
- 88 sites in United States, Argentina and 17 more
- Volunteers
- 98 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
- 12 sites in United States, Canada and 7 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
PIK3CA-related Overgrowth Spectrum (PROS)
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).
- Trial name
- NCT06997588
- Testing
- Alpelisib
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 140 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
- 6 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma, Non Small Cell Lung Cancer
Dabrafenib and/or Trametinib Rollover Study
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have…
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers
- Trial name
- NCT03340506
- Testing
- dabrafenib, trametinib
- Where
- 38 sites in United States, Argentina and 13 more
- Volunteers
- 100 people
- Sponsor
- 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
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
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
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
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
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
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple…
- Trial name
- NCT06846281
- Testing
- Remibrutinib oral treatment, Ocrelizumab
- Where
- 131 sites in United States, Argentina and 17 more
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care…
- Trial name
- NCT07570979
- Testing
- INR731, Enzalutamide, Abiraterone
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals