Clinical trials: sponsored by Novartis Pharmaceuticals
Polycythemia Vera
MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera
The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with Polycythemia Vera.
- Trial name
- NCT05269771
- Testing
- Ruxolitinib
- Where
- 25 sites in Australia, Belgium and 6 more
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
- Trial name
- PORTRAIT (NCT07223476)
- Where
- United States
- Volunteers
- 1,926 people
- Sponsor
- Novartis Pharmaceuticals
PIK3CA-Related Overgrowth Spectrum
A Study of the Epidemiology and Hospital Management of Patients With PROS in France
The purpose of this study was to estimate the incidence and prevalence of a group of genetic disorders known as PIK3CA-Related Overgrowth Spectrum (PROS) in France.
- Trial name
- EpiPROS (NCT07222423)
- Where
- United States
- Volunteers
- 3,605 people
- Sponsor
- Novartis Pharmaceuticals
Knee Osteoarthritis
A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).
- Trial name
- NCT04814368
- Testing
- canakinumab, LNA043
- Where
- 11 sites in United States, Czechia and 4 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms, Prostate Cancer
Study of Diagnostic Performance of [18F]CTT1057 in BCR
The current study aimed at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical…
- Conditions
- Prostatic Neoplasms, Prostate Cancer, Recurrence
- Trial name
- GuidePath (NCT04838613)
- Testing
- [18F]CTT1057, [68Ga]Ga-PSMA-11
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 190 people
- Sponsor
- Novartis Pharmaceuticals
Proliferative Diabetic Retinopathy
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR).
- Trial name
- CONDOR (NCT04278417)
- Testing
- Brolucizumab 6 mg, Panretinal photocoagulation laser
- Where
- 120 sites in United States, Argentina and 14 more
- Volunteers
- 689 people
- Sponsor
- Novartis Pharmaceuticals
Acute Coronary Syndrome
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS)…
- Trial name
- V-INCEPTION (NCT04873934)
- Testing
- Inclisiran
- Where
- 88 sites in United States
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment
- Trial name
- AgAIN (NCT04632927)
- Testing
- Secukinumab, Ustekinumab
- Where
- 28 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia - Chronic Phase
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior…
- Trial name
- AIM4CML (NCT04666259)
- Testing
- ABL001
- Where
- 26 sites in United States
- Volunteers
- 56 people
- Sponsor
- Novartis Pharmaceuticals
Sjogren's Syndrome
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525).
- Trial name
- TWINSS Extn (NCT04541589)
- Testing
- Iscalimab
- Where
- 62 sites in United States, Argentina and 21 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
This study was planned to determine if neoadjuvant capmatinib could improve the major pathological response (MPR) in patients with Stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) lung cancers with Mesenchymal Epithelial…
- Trial name
- Geometry-N (NCT04926831)
- Testing
- capmatinib
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change…
- Trial name
- V-Mono (NCT05763875)
- Testing
- Inclisiran, Ezetimibe
- Where
- 42 sites in United States, Colombia and 3 more
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.
The primary purpose of this study was to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with Acute myeloid leukemia (AML)/secondary AML…
- Trial name
- NCT04623216
- Testing
- Sabatolimab, Azacitidine
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Migraine
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
- Trial name
- DRAGON (NCT03867201)
- Testing
- Erenumab
- Where
- 63 sites in China, India and 7 more
- Volunteers
- 557 people
- Sponsor
- Novartis Pharmaceuticals
Amyotrophic Lateral Sclerosis
Study of Safety and Proof of the Mechanism of BLZ945 in ALS Patients
It was an open label study to evaluate safety, tolerability and brain microglia response in participants with Amyotrophic Lateral Sclerosis (ALS) following multiple doses of BLZ945.
- Trial name
- NCT04066244
- Testing
- BLZ945
- Where
- 4 sites in United States, Finland and 1 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral…
- Trial name
- NCT04878432
- Testing
- MBG453, Azacitidine, Decitabine
- Where
- 15 sites in United States
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by…
- Trial name
- NCT05795153
- Testing
- LOU064
- Where
- 44 sites in United States, Argentina and 8 more
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Immune Thrombocytopenia (ITP), Cold Agglutinin Disease (CAD)
Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders
The main purpose of this study was to evaluate the efficacy and safety of iptacopan in participants with autoimmune benign hematological disorders such as primary immune thrombocytopenia and primary cold agglutinin disease.
- Trial name
- NCT05086744
- Testing
- Iptacopan
- Where
- 8 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease (SCD)
Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
The purpose of this study was to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 2 to <18 years with a history of Vaso-Occlusive Crisis (VOC) with or without…
- Trial name
- NCT03474965
- Testing
- Crizanlizumab
- Where
- 35 sites in United States, Belgium and 12 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
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