Clinical trials: sponsored by Novartis Pharmaceuticals
Macular Polypoidal Choroidal Vasculopathy (PCV)
Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy
This study is a 60-week, two-arm, randomized, open-label, active-controlled, multi-center study in patients with Polypoidal choroidal vasculopathy (PCV) who have not previously received anti-Vascular endothelial growth factor…
- Trial name
- PROUD (NCT05666804)
- Testing
- Brolucizumab 6mg
- Where
- 15 sites in South Korea
- Volunteers
- 148 people
- Sponsor
- Novartis Pharmaceuticals
Sepsis-associated Acute Kidney Injury
Concept Elicitation and Patient Experience Mapping in SA-AKI
This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI)
- Trial name
- NCT07180238
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk…
- Trial name
- LEAD Melanoma (NCT04961619)
- Testing
- dabrafenib, trametinib
- Where
- 9 sites in Turkey (Türkiye)
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Graft vs Host Disease
Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children…
- Trial name
- REACH 5 (NCT03774082)
- Testing
- INC424
- Where
- 21 sites in Brazil, Canada and 12 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
HR+HER2- Advanced Breast Cancer
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia
This is а prospective, non-interventional, primary data collection cohort study to evaluate the clinical outcomes of the combination of ribociclib + ET and combination chemotherapy in the real-life setting in Russia.
- Trial name
- ValerEE (NCT06148506)
- Testing
- Ribociclib, Combination chemotherapy
- Where
- 20 sites in Russia
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)
- Trial name
- NCT05170724
- Testing
- Remibrutinib
- Sponsor
- Novartis Pharmaceuticals
Non-Tuberculous Mycobacterial (NTM) Infections
Lamprene Multiple Patient Program
Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy.
- Trial name
- NCT04334070
- Testing
- Lamprene®/Clofazimine
- Sponsor
- Novartis Pharmaceuticals
C3 Glomerulopathy (C3G), Paroxysmal Nocturnal Hemoglobinuria (PNH)
Managed Access Programs for LNP023, Iptacopan
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan
- Trial name
- NCT05222412
- Testing
- Iptacopan
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care
This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a…
- Trial name
- CONNECT (NCT06004453)
- Testing
- Heart Failure medications
- Where
- 94 sites in Germany
- Volunteers
- 899 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia in Chronic Phase
Managed Access Programs for ABL001, Asciminib
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib
- Trial name
- NCT04360005
- Testing
- Asciminib
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease
The purpose of this MAP Cohort Treatment Plan is to allow access to siponimod for eligible patients diagnosed with Secondary Progressive Multiple Sclerosis with active disease.
- Trial name
- NCT04540861
- Testing
- Siponimod
- Sponsor
- Novartis Pharmaceuticals
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
- Trial name
- NCT03574545
- Testing
- ianalumab
- Where
- 2 sites in Germany, Jordan
- Volunteers
- 48 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing-remitting Multiple Sclerosis, Active Secondary Progressive Multiple Sclerosis
Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen
This study was an uncontrolled, central registration system, open-label, multicenter observational study in patients using Kesimpta for the labeled indication.
- Trial name
- NCT04940065
- Testing
- Kesimpta
- Where
- 103 sites in Japan
- Volunteers
- 367 people
- Sponsor
- Novartis Pharmaceuticals
Huntington Disease
An Extension Study to Evaluate the Long-Term Safety and Efficacy of Votoplam in Participants With Huntington's Disease (HD)
The primary goal of this study is to evaluate the long-term safety and pharmacodynamic effects of votoplam in participants with HD.
- Trial name
- NCT06254482
- Testing
- Votoplam
- Where
- 24 sites in Australia, Austria and 8 more
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Migraine
Migraine Survey in Gulf Region
The objective of this study was to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients who newly started on erenumab over 12 weeks
- Trial name
- NCT06237062
- Testing
- erenumab
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria
This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07235020)
- Testing
- INE963
- Where
- 6 sites in Burkina Faso, Côte d’Ivoire and 4 more
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF)
Managed Access Programs for INC424, Ruxolitinib
The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib
- Conditions
- Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), Thrombocythemia Myelofibrosis (PET-MF), Severe/Very Severe COVID-19 Illness
- Trial name
- NCT04745637
- Testing
- Ruxolitinib
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors, Triple Negative Breast Cancer
A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or…
- Conditions
- Advanced Solid Tumors, Triple Negative Breast Cancer, Chordoma and Alveolar Soft Part Sarcoma
- Trial name
- NCT02936102
- Testing
- FAZ053, PDR001
- Where
- 12 sites in United States, Canada and 7 more
- Volunteers
- 154 people
- Sponsor
- Novartis Pharmaceuticals
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