Clinical trials: sponsored by Novartis Pharmaceuticals
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with…
- Trial name
- V-INITIATE (NCT04929249)
- Testing
- Inclisiran
- Where
- 43 sites in United States
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Cardiomyopathy, Hypertrophic
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
- Trial name
- NCT04164732
- Testing
- LCZ696
- Where
- 18 sites in United States, Germany and 4 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Moderate to Severe Chronic Plaque-type Psoriasis
Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis.
- Trial name
- NCT03668613
- Testing
- secukinumab low dose, secukinumab high dose
- Where
- 23 sites in United States, Belgium and 7 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Early Manifest Huntington Disease
A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease
This is the first study of branaplam in adults with Huntington's Disease (HD) to determine the correct dose required to lower mutant huntingtin protein (mHTT) levels in the cerebrospinal fluid (CSF) to a degree expected to be…
- Trial name
- VIBRANT-HD (NCT05111249)
- Testing
- Branaplam
- Where
- 12 sites in Canada, France and 3 more
- Volunteers
- 26 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria
The purpose of this study was to determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with paroxysmal nocturnal hemoglobinuria (PNH).
- Trial name
- NCT02534909
- Testing
- LFG316, LNP023
- Where
- 7 sites in Czechia, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular Age-related Macular Degeneration
Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.
The purpose of this study was to identify innovative early imaging parameters as predictors of the long-term clinical response to brolucizumab in terms of fluid resolution in patients with wet Age-related Macular Degeneration…
- Trial name
- IMAGINE (NCT04774926)
- Testing
- Brolucizumab
- Where
- 20 sites in Italy
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, Allogeneic Stem Cell Transplantation
A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
The purpose of this study was to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with Acute Myeloid Leukemia…
- Trial name
- NCT05447663
- Testing
- Siremadlin
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2…
- Trial name
- NCT03785405
- Testing
- sacubitril/valsartan
- Where
- 79 sites in United States, Argentina and 25 more
- Volunteers
- 216 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
The purpose of the study was to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a…
- Trial name
- GeoMETry-III (NCT04427072)
- Testing
- Capmatinib, Docetaxel
- Where
- 43 sites in Belgium, Brazil and 16 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis (RMS)
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to…
- Trial name
- NCT04878211
- Testing
- Ofatumumab, mRNA COVID-19 vaccine, interferon or glatiramer acetate
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Immune Thrombocytopenia (ITP)
A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP
The purpose of this study was to compare the ability of eltrombopag in combination with a short course of high-dose dexamethasone to induce sustained response off treatment in patients with newly-diagnosed ITP versus 1-3 cycles…
- Trial name
- XPAG-ITP (NCT04346654)
- Testing
- Eltrombopag, Dexamethasone
- Where
- 10 sites in Germany
- Volunteers
- 26 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant Rejection
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.
- Trial name
- CONTRAIL I (NCT03781414)
- Testing
- CFZ533, Tacrolimus - MMF - corticosteroids
- Where
- 29 sites in United States, Argentina and 8 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy…
- Trial name
- NCT05232864
- Testing
- Secukinumab
- Where
- 18 sites in Australia, Brazil and 11 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3…
- Trial name
- INVIGORATE 2 (NCT04209205)
- Testing
- AIN457 6 mg/kg i.v., AIN457 3 mg/kg
- Where
- 80 sites in United States, Brazil and 13 more
- Volunteers
- 381 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Lymphocytic Leukemia (CLL)
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation…
- Trial name
- NCT03400176
- Testing
- VAY736, ibrutinib
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation…
- Trial name
- KYRIOS (NCT04869358)
- Testing
- Ofatumumab
- Where
- 6 sites in Germany
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without…
- Trial name
- SELUNE (NCT04181762)
- Testing
- secukinumab
- Where
- 105 sites in United States, Argentina and 32 more
- Volunteers
- 275 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)
This was a randomized, open, parallel, controlled, multi-center, interventional, cross-sectional study to evaluate the detection rate of Psoriatic arthritis (PsA) in Korean moderate to severe Psoriasis (PsO) patients with or…
- Trial name
- ASAP (NCT05758402)
- Testing
- Routine practice group, EARP group
- Where
- 15 sites in South Korea
- Volunteers
- 368 people
- Sponsor
- Novartis Pharmaceuticals
In Escalation: All Patients With Solid Tumors and Lymphoma, In Expansion: Melanoma, Non-small Cell Lung Cancer
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab
The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for…
- Trial name
- NCT04261439
- Testing
- NIZ985, Spartalizumab, Tislelizumab
- Where
- 9 sites in United States, Belgium and 5 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
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