Clinical trials: sponsored by Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to complement inhibitor therapy.
- Trial name
- APPOINT-PNH (NCT04820530)
- Testing
- Iptacopan (LNP023)
- Where
- 12 sites in China, France and 6 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A
The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on…
- Trial name
- Canopy-A (NCT03447769)
- Testing
- Canakinumab
- Where
- 283 sites in United States, Argentina and 39 more
- Volunteers
- 1,382 people
- Sponsor
- Novartis Pharmaceuticals
Sjogren Syndrome, Mixed Connective Tissue Disease
A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
This study was a basket trial designed to establish safety, tolerability and efficacy of MHV370 in Sjögren's Syndrome (SjS) and Mixed Connective Tissue Disease (MCTD).
- Trial name
- NCT04988087
- Testing
- MHV370
- Where
- 10 sites in China, Germany and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
This study was designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with…
- Trial name
- EPIK-B4 (NCT04899349)
- Testing
- Alpelisib, Fulvestrant, Metformin XR
- Where
- 2 sites in United States, Malaysia
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
Age-related Macular Degeneration
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth…
- Trial name
- TALON (NCT04005352)
- Testing
- Brolucizumab 6 mg, Aflibercept 2 mg
- Where
- 118 sites in United States, Argentina and 18 more
- Volunteers
- 734 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Membranous Nephropathy
Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy
This was a randomized, open-label, two arm, parallel group, proof-of-concept, nonconfirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with Idiopathic (primary) membranous nephropathy…
- Trial name
- NCT04154787
- Testing
- LNP023, Rituximab
- Where
- 18 sites in Argentina, China and 7 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease (SCD)
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD)…
- Trial name
- NCT03264989
- Testing
- crizanlizumab
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Ocular Pain
Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
The study was designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (5 mg/mL and 15 mg/mL) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and…
- Trial name
- NCT04630158
- Testing
- SAF312
- Where
- 28 sites in United States, Japan and 1 more
- Volunteers
- 153 people
- Sponsor
- Novartis Pharmaceuticals
Familial Cold Autoinflammatory Syndrome
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
- Trial name
- DFV890-FCAS (NCT04868968)
- Testing
- DFV890
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants
This was a Phase I, open-label, single-dose, parallel-group study in participants with mild hepatic impairment (HI) and healthy matched control participants with normal hepatic function designed to evaluate the PK of pelacarsen…
- Trial name
- NCT05026996
- Testing
- Pelacarsen
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Migraine, Migraine Disorders
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.
- Conditions
- Migraine, Migraine Disorders, Migraine Headache
- Trial name
- APOLLON (NCT04084314)
- Testing
- Erenumab
- Where
- 75 sites in Germany
- Volunteers
- 701 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease (SCD)
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle…
- Trial name
- STEADFAST (NCT04053764)
- Testing
- Crizanlizuamb, Standard of Care
- Where
- 24 sites in United States, Brazil and 9 more
- Volunteers
- 58 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol…
- Conditions
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- Trial name
- SPIRIT (NCT04807400)
- Testing
- Inclisiran, Behavioural Support, Background lipid lowering therapy
- Where
- 17 sites in United Kingdom
- Volunteers
- 892 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular Age-related Macular Degeneration
An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the…
- Trial name
- TALON Ext (NCT04597632)
- Testing
- brolucizumab
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 248 people
- Sponsor
- Novartis Pharmaceuticals
NSCLC, Non Small Cell Lung Cancer, RCC, Renal Cell Cancer
A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma
The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to…
- Conditions
- NSCLC, Non Small Cell Lung Cancer, RCC, Renal Cell Cancer, Pancreatic Cancer, Urothelial Cancer
- Trial name
- NCT03207867
- Testing
- NIR178, PDR001
- Where
- 21 sites in United States, Argentina and 13 more
- Volunteers
- 315 people
- Sponsor
- Novartis Pharmaceuticals
Obesity
Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM
This was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without Type 2 Diabetes Mellitus.
- Trial name
- NCT05199090
- Testing
- MBL949
- Where
- 4 sites in United States
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥…
- Trial name
- SMART (NCT04851873)
- Testing
- OAV101
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Muscular Atrophy, Spinal
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA) (OFELIA)
This was a phase IV Open-label, single-arm, single-dose, multicenter study, to evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with SMA with bi-allelic mutations in…
- Trial name
- OFELIA (NCT05073133)
- Testing
- OAV101
- Where
- 5 sites in Argentina, Brazil
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy
EILEEN was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in Turkey.
- Trial name
- NCT06619704
- Where
- United States
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
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