Clinical trials: sponsored by Novartis Pharmaceuticals
Non-Small-Cell Lung
Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.
- Trial name
- CANOPY-2 (NCT03626545)
- Testing
- Canakinumab, Docetaxel
- Where
- 78 sites in United States, Argentina and 24 more
- Volunteers
- 245 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia (AML)
A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)
The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3…
- Trial name
- NCT03512197
- Testing
- Midostaurin, Chemotherapy
- Where
- 133 sites in United States, Argentina and 18 more
- Volunteers
- 511 people
- Sponsor
- Novartis Pharmaceuticals
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Ankylosing Spondylitis
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing…
- Trial name
- SURPASS (NCT03259074)
- Testing
- GP2017 (adalimumab biosimilar), AIN457 150 mg
- Where
- 171 sites in United States, Argentina and 27 more
- Volunteers
- 859 people
- Sponsor
- Novartis Pharmaceuticals
Giant Cell Arteritis
A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis
This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with…
- Trial name
- TitAIN (NCT03765788)
- Testing
- Secukinumab 300 mg, s.c., Prednisolone
- Where
- 11 sites in Germany
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment
The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior…
- Trial name
- IO-PAZ (NCT03200717)
- Testing
- Pazopanib
- Where
- 22 sites in United States, Argentina and 9 more
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line
This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients…
- Trial name
- NOFRETETE (NCT05734053)
- Testing
- Nilotinib
- Where
- 77 sites in Germany
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer
This was a retrospective observational study of patients with advanced breast cancer (BC). This non-interventional study was conducted using discrete structured data and medical record abstraction, if needed, from patients…
- Trial name
- NCT05982886
- Where
- United States
- Volunteers
- 1,093 people
- Sponsor
- Novartis Pharmaceuticals
BRAF Positive Metastatic Melanoma
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
This was a retrospective real-world evidence cohort study.
- Trial name
- NCT05984615
- Where
- United States
- Volunteers
- 1,961 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myocardial Infarction
Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
This was a retrospective study using the Taiwan's National Health Insurance Research Database (NHIRD). The study employed two study designs for different purposes as follows: A cross-sectional analysis was conducted to explore…
- Trial name
- NCT05974397
- Where
- Taiwan
- Volunteers
- 124,018 people
- Sponsor
- Novartis Pharmaceuticals
Gouty Arthritis
Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France
This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the National Health Data System (Système National des Données de Santé, SNDS).
- Trial name
- NCT05964946
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
de Novo Heart Failure
Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients
This was a non-interventional retrospective cohort study of de novo heart failure with reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment on either sacubitril/valsartan or commencing or…
- Trial name
- NCT05963282
- Where
- United States
- Volunteers
- 9,870 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating…
- Trial name
- NCT03580369
- Testing
- Ligelizumab, Omalizumab
- Where
- 161 sites in United States, Argentina and 27 more
- Volunteers
- 1,072 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer (NSCLC)
Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.
The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and…
- Trial name
- AdvanTIG-306 (NCT05791097)
- Testing
- Ociperlimab, Tislelizumab, Pembrolizumab
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
- Trial name
- NCT05078580
- Testing
- Iptacopan
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Triple Negative Breast Cancer
Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer
The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and…
- Trial name
- AdvanTIG-211 (NCT05809895)
- Testing
- Ociperlimab, Tislelizumab, Paclitaxel
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies
Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing…
- Trial name
- NCT05950308
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers
Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.
This is a Phase 1 study designed to assess the relative bioavailability (BA), safety and tolerability and PK of the pediatric and adult formulations of branaplam.
- Trial name
- NCT05330286
- Testing
- LMI070
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure
This is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of…
- Trial name
- LOCATE-HF (NCT05870709)
- Testing
- sacubitril/valsartan
- Sponsor
- Novartis Pharmaceuticals
Advanced Hepatocellular Carcinoma
Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC
The purpose of this study of capmatinib (INC280) and spartalizumab (PDR001) was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of spartalizumab administered…
- Trial name
- NCT02795429
- Testing
- Spartalizumab, Capmatinib
- Where
- 17 sites in Canada, China and 6 more
- Volunteers
- 89 people
- Sponsor
- Novartis Pharmaceuticals
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