Clinical trials: sponsored by Novartis Pharmaceuticals
PIK3CA-related Overgrowth Spectrum (PROS)
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
This is a prospective Phase II multi-center study with an initial 16-week, randomized, double-blind, placebo-controlled period, followed by two extension periods to assess the efficacy, safety and pharmacokinetics (PK) of…
- Trial name
- EPIK-P2 (NCT04589650)
- Testing
- Alpelisib
- Where
- 36 sites in United States, Canada and 10 more
- Volunteers
- 236 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016)…
- Trial name
- NCT02555683
- Testing
- QAW039
- Where
- 234 sites in United States, Argentina and 25 more
- Volunteers
- 894 people
- Sponsor
- Novartis Pharmaceuticals
Complement 3 Glomerulopathy
A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain
This study aims to characterize the patient profiles and the clinical experience of iptacopan treatment in adult patients with C3G treated through an early access program (EAP) in Spain.
- Trial name
- ROUTE-C3G (NCT07598448)
- Where
- 2 sites in Spain
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany
- Trial name
- FILAXOS (NCT06551519)
- Testing
- ofatumumab, DMT category 1
- Where
- 82 sites in Germany
- Volunteers
- 519 people
- Sponsor
- Novartis Pharmaceuticals
Fascioliasis
Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6…
- Trial name
- NCT04230148
- Testing
- Egaten (Triclabendazole) 250 mg tablets
- Where
- 10 sites in Colombia, Egypt and 3 more
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Primary IgA Nephropathy
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials.
- Trial name
- NCT04557462
- Testing
- LNP023
- Where
- 161 sites in United States, Argentina and 34 more
- Volunteers
- 540 people
- Sponsor
- Novartis Pharmaceuticals
Inclisiran Formulation
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a…
- Trial name
- NCT07626281
- Testing
- Inclisiran formulation containing PS80, Currently marketed inclisiran formulation
- Where
- 6 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
CAR-T Long Term Follow Up (LTFU) Study
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required.
- Trial name
- PAVO (NCT02445222)
- Testing
- Previously treated CAR-T patients
- Where
- 120 sites in United States, Australia and 21 more
- Volunteers
- 1,105 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Myeloid, Chronic-Phase
A Study of Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia Patients in Kuwait
The aim of this study is to assess demographics, clinical features, treatment patterns, and the comorbidity burden and its impact on CML patients in the real-world clinical setting in Kuwait.
- Trial name
- NCT07454850
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Castration-Resistant Prostatic Cancer
An External Control Arm Study Comparing Survival Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With 177Lu-PSMA-617 vs Androgen Receptor Pathway Inhibitor (ARPI) Switch in Routine Care
The aim of this study is to assess the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial…
- Trial name
- NCT07843758
- Where
- Switzerland
- Volunteers
- 1,525 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia
A Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment
This study aims to evaluate treatment preferences of patients with Primary Immune Thrombocytopenia (ITP) in the United States (US) by conducting a preference elicitation survey.
- Trial name
- NCT07786077
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure With Reduced Ejection Fraction
A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction…
- Trial name
- NCT07465653
- Testing
- HJB647 low dose, HJB647 high dose
- Where
- 6 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Newly Diagnosed and Recurrent Glioblastoma
Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma
This study will investigate different doses of [177Lu]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of…
- Trial name
- NCT05739942
- Testing
- [177Lu]Lu-NeoB, [68Ga]Ga-NeoB, Temozolomide
- Where
- 16 sites in United States, France and 4 more
- Volunteers
- 42 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy (IgAN)
A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy
This is a Phase IIIb, multicenter, two-arm, randomized, double-blind, parallel group study to evaluate the efficacy and safety of zigakibart + atrasentan compared to zigakibart + placebo in patients with primary IgAN at risk of…
- Trial name
- LUMINA IgAN (NCT07850752)
- Testing
- zigakibart, atrasentan
- Volunteers
- 340 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer…
- Trial name
- TulmiSTAR-02 (NCT07190300)
- Testing
- Tulmimetostat, Darolutamide, Abiraterone
- Where
- 31 sites in United States, Australia and 12 more
- Volunteers
- 181 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in…
- Trial name
- EPIK-B5 (NCT05038735)
- Testing
- Alpelisib, Fulvestrant
- Where
- 68 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 210 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria…
- Trial name
- NCT06865651
- Testing
- Remibrutinib
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
A Study of Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy
This study aims to assess the real-world patterns of disease modifying therapy (DMT) use before, during, and after pregnancy in women with multiple sclerosis (MS).
- Trial name
- NCT07844070
- Where
- United States
- Volunteers
- 2,607 people
- Sponsor
- Novartis Pharmaceuticals
Plaque Psoriasis, Psoriatic Arthritis
Modifying PEST for Psoriatic Arthritis Screening
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
- Trial name
- ScreenX (NCT06382051)
- Testing
- PEST Screening group
- Where
- 30 sites in Canada
- Volunteers
- 502 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Generalized Myasthenia Gravis
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.
- Trial name
- RELIEVE (NCT06744920)
- Testing
- Remibrutinib (Blinded), Remibrutinib (Open Label)
- Where
- 120 sites in United States, Argentina and 18 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
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