Clinical trials: sponsored by Novartis Pharmaceuticals
Healthy Volunteers, Pulmonary Arterial Hypertension
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
- Trial name
- NCT06649110
- Testing
- LTP
- Where
- 87 sites in United States, Argentina and 16 more
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia - Chronic Phase
A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy
This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for…
- Trial name
- ASC4REAL-2 (NCT07091019)
- Testing
- TKIs
- Where
- 17 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy, Immunoglobulin A Nephropathy
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
The ASSIST study was a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs.
- Trial name
- ASSIST (NCT05834738)
- Testing
- Atrasentan
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe HS Within the Italian Population
The aim of this study is to generate real-world evidence to fill knowledge gaps regarding the response to secukinumab in patients with moderate to severe HS, its treatment patterns, the clinical characteristics of patients on…
- Trial name
- ANIMA - Italy (NCT07543419)
- Where
- 16 sites in Italy
- Volunteers
- 250 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.
The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and…
- Trial name
- ANIMA (NCT05921994)
- Testing
- secukinumab
- Where
- 80 sites in Germany
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria
This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether/lumefantrine 5 mg/60 mg) in neonates and infants weighing ≥2 kg to <5 kg with uncomplicated malaria due to Plasmodium…
- Trial name
- NCT07713602
- Testing
- Coartem® Baby
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Myelofibrosis, Primary Myelofibrosis
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi).
- Conditions
- Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Trial name
- MANIFEST-2 (NCT04603495)
- Testing
- Pelabresib, Ruxolitinib
- Where
- 156 sites in United States, Australia and 20 more
- Volunteers
- 430 people
- Sponsor
- Novartis Pharmaceuticals
Hyperlipoproteinemia(a)
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany
Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established…
- Trial name
- NCT05305664
- Testing
- Pelacarsen (TQJ230) 80 mg s.c.
- Where
- 13 sites in Germany
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Gastrointestinal Stromal Tumors
Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib
The purpose of this multicenter, single-arm, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
- Trial name
- NCT00756509
- Testing
- Nilotinib
- Where
- 10 sites in Finland, France and 3 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Trial name
- VICTORION-LEAP (NCT07543731)
- Where
- Switzerland
- Volunteers
- 5,995 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia
This study is constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage. The purpose of the TFR1 stage is to assess the effect of nilotinib reduced to half the standard dose for…
- Trial name
- DANTE (NCT03874858)
- Testing
- Nilotinib, Asciminib
- Where
- 26 sites in Italy
- Volunteers
- 135 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer
Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.
- Trial name
- NCT06517719
- Testing
- lutetium (177Lu) vipivotide tetraxetan
- Where
- 38 sites in Germany
- Volunteers
- 500 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
- 87 sites in United States, Argentina and 17 more
- Volunteers
- 98 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of…
- Trial name
- REPOWER (NCT07243002)
- Where
- United Kingdom
- Volunteers
- 3,000 people
- Sponsor
- Novartis Pharmaceuticals
IC-MPGN
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative…
- Trial name
- APPARENT (NCT05755386)
- Testing
- iptacopan
- Where
- 131 sites in United States, Argentina and 21 more
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
C3 Glomerulopathy
Fabhalta Capsules Specified Drug-use Survey
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
- Trial name
- NCT07156149
- Where
- 29 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617)…
- Trial name
- NCT06004661
- Testing
- AAA617, 68Ga-PSMA-11
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
FLT3-mutated Acute Myeloid Leukemia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia.
- Trial name
- NCT03591510
- Testing
- Midostaurin, Fludarabine, Cytarabine
- Where
- 15 sites in Czechia, Germany and 8 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC), KRAS G12-mutant NSCLC
Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
The purpose of this first in human (FIH) trial was to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in…
- Conditions
- Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal Squamous Cell Cancer (SCC), Head/Neck SCC
- Trial name
- NCT03114319
- Testing
- TNO155, TNO155 in combination with EGF816 (nazartinib)
- Where
- 18 sites in United States, Canada and 7 more
- Volunteers
- 227 people
- Sponsor
- Novartis Pharmaceuticals
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