Clinical trials: sponsored by Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
The Belgian REAL (BE.REAL) Registry
This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected.
- Trial name
- BE REAL (NCT05726838)
- Testing
- Inclisiran
- Volunteers
- 600 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small-Cell Lung Carcinoma
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting.
- Trial name
- NCT05703516
- Testing
- Capmatinib
- Where
- 10 sites in South Korea
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy, Focal Segmental Glomerulosclerosis
Atrasentan in Patients With Proteinuric Glomerular Diseases
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.
- Conditions
- IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease
- Trial name
- AFFINITY (NCT04573920)
- Testing
- Atrasentan
- Where
- 33 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China
The implementation of new standards for the management of PNH and the use of iptacopan in patients with PNH are expected to change the treatment landscape and improve the overall prognosis of patients.
- Trial name
- PNH-NIS (NCT06931691)
- Testing
- LNP023
- Where
- 14 sites in China
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Rhinosinusitis With Nasal Polyps
Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps
This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.
- Trial name
- NCT05626257
- Testing
- Xolair
- Where
- 16 sites in South Korea
- Volunteers
- 135 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Heart Disease
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein…
- Trial name
- V-INVINCIBLE (NCT06941792)
- Testing
- inclisiran sodium injection, Standard of Care
- Where
- 19 sites in China
- Volunteers
- 1,590 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing-Remitting Multiple Sclerosis
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy.
- Trial name
- SOSTOS (NCT05090371)
- Testing
- Ofatumumab, Disease modifying treatment (DMT)
- Where
- 43 sites in United States, Canada
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a…
- Trial name
- ASSURE-3 (NCT06092879)
- Testing
- Asciminib
- Where
- 52 sites in France
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Study Evaluating Kesimpta® Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies
KAIROS was a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data was collected via questionnaires and an electronic case report form (eCRF) over a period of one year (max.
- Trial name
- KAIROS (NCT05566756)
- Testing
- Ofatumumab
- Where
- 40 sites in Germany
- Volunteers
- 307 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.
- Trial name
- ALITHIOS (NCT03650114)
- Testing
- Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap), 13-valent pneumococcal conjugate vaccine (13-PCV)
- Where
- 295 sites in United States, Argentina and 35 more
- Volunteers
- 1,882 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Pancreatic Ductal Adenocarcinoma
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma…
- Trial name
- NCT04935359
- Testing
- NIS793, Nab-paclitaxel, Gemcitabine
- Where
- 113 sites in United States, Australia and 25 more
- Volunteers
- 511 people
- Sponsor
- Novartis Pharmaceuticals
Active Secondary Progressive Multiple Sclerosis
Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy
This is an observational, multicenter, single-arm, prospective study conducted in Italy
- Trial name
- ITASIA (NCT05376579)
- Testing
- siponimod
- Where
- 24 sites in Italy
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
Ilaris NIS in Korea
This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes…
- Conditions
- Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS)
- Trial name
- REASSURE (NCT06838143)
- Testing
- Ilaris
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Major Depressive Disorder With Suicidal Ideation With Intent
Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent
- Trial name
- NCT04722666
- Testing
- MIJ821 Intravenous Injection
- Where
- 39 sites in United States, Argentina and 12 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Sjögren Syndrome
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
- Trial name
- TWINSS (NCT03905525)
- Testing
- CFZ533
- Where
- 71 sites in United States, Argentina and 21 more
- Volunteers
- 273 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Remitting Multiple Sclerosis (RRMS)
ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS
The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context…
- Trial name
- ELIOS (NCT06733922)
- Testing
- ETNATM-ProgMS
- Where
- 14 sites in Canada
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus (SLE)
Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to…
- Trial name
- NCT03656562
- Testing
- VAY736, CFZ533
- Where
- 31 sites in Argentina, Australia and 13 more
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis (MS)
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
- Trial name
- NEOS (NCT04926818)
- Testing
- Fingolimod, Ofatumumab, Siponimod
- Where
- 51 sites in United States, Argentina and 23 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult participants with moderate to severe atopic dermatitis (AD).
- Trial name
- NCT07220577
- Testing
- GIA632
- Where
- 28 sites in United States, Bulgaria and 7 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
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