Clinical trials: sponsored by Novartis Pharmaceuticals
Sjogrens Syndrome
A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301…
- Trial name
- NEPTUNUS-Ext (NCT05985915)
- Testing
- Ianalumab (VAY736)
- Where
- 198 sites in United States, Argentina and 33 more
- Volunteers
- 612 people
- Sponsor
- Novartis Pharmaceuticals
Gastroenteropancreatic Neuroendocrine Tumor
A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
This study aims to characterize current treatment patterns and clinical outcomes among newly diagnosed GEP-NET patients in the United States using open-source Longitudinal Prescription Claims (LRx) and Patient Centric Medical…
- Trial name
- NCT07635316
- Where
- United States
- Volunteers
- 4,023 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
- Trial name
- NCT06799000
- Testing
- Remibrutinib Dose A, Remibrutinib Dose B
- Where
- 139 sites in United States, Argentina and 18 more
- Volunteers
- 588 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
- Trial name
- SIRIUS-LN (NCT05126277)
- Testing
- ianalumab s.c. q4w, ianalumab s.c. q12w
- Where
- 145 sites in United States, Argentina and 25 more
- Volunteers
- 452 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Neuroendocrine Prostate Cancer
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide…
- Trial name
- NCT06379217
- Testing
- [68Ga]Ga-PSMA-11, [68Ga]GA-DOTA-TATE, [68Ga]Ga-NeoB
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Inducible Urticaria
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).
- Trial name
- NCT05976243
- Testing
- Remibrutinib
- Where
- 130 sites in United States, Argentina and 26 more
- Volunteers
- 362 people
- Sponsor
- Novartis Pharmaceuticals
Papulopustular Rosacea
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular…
- Trial name
- NCT07681271
- Testing
- LOU064
- Where
- 12 sites in United States, Bulgaria and 6 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, Lupus Nephritis
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus
The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.
- Trial name
- NCT05798117
- Testing
- YTB323
- Where
- 10 sites in Australia, France and 3 more
- Volunteers
- 21 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 (Cohort C2)
This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07811908)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 13 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
- Trial name
- NCT05268289
- Testing
- Iptacopan (part 1), Iptacopan (part 2)
- Where
- 74 sites in United States, Argentina and 17 more
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Iptacopan in Patients With ANCA Associated Vasculitis
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or…
- Trial name
- NCT06388941
- Testing
- Iptacopan, Rituximab
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after…
- Trial name
- VAY RE-HIT (NCT07039422)
- Testing
- Ianalumab
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
The aim of this study is to support development of asciminib in the pediatric population (1 to < 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose…
- Trial name
- NCT07354074
- Testing
- Asciminib single agent
- Where
- 34 sites in United States, Australia and 13 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP).
- Trial name
- NCT07498426
- Testing
- NIO752
- Where
- 64 sites in United States, Australia and 10 more
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Acute Coronary Syndrome (ACS)
Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL
CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in…
- Trial name
- NCT07625306
- Testing
- Pelacarsen
- Sponsor
- Novartis Pharmaceuticals
Non-radiographic Axial Spondyloarthritis
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission.
- Trial name
- NCT05622708
- Testing
- Secukinumab
- Where
- 61 sites in Belgium, Brazil and 16 more
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
PIK3CA-related Overgrowth Spectrum (PROS)
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
This Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth…
- Trial name
- EPIK-P3 (NCT04980833)
- Testing
- Alpelisib
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease (ASCVD)
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on…
- Trial name
- ADD-VANTAGE (NCT06813911)
- Testing
- Pelacarsen, Inclisiran
- Where
- 94 sites in United States, China and 9 more
- Volunteers
- 246 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus…
- Trial name
- SIRIUS-SLE 2 (NCT05624749)
- Testing
- ianalumab
- Where
- 90 sites in United States, Argentina and 13 more
- Volunteers
- 288 people
- Sponsor
- Novartis Pharmaceuticals
Cardiovascular Disease and Lipoprotein(a)
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
- Trial name
- NCT07517263
- Testing
- Pelacarsen (TQJ230)
- Where
- 646 sites in United States, Argentina and 38 more
- Volunteers
- 5,700 people
- Sponsor
- Novartis Pharmaceuticals
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