Clinical trials: completed, sponsored by Novartis Pharmaceuticals
Hepatic Impairment
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled…
- Trial name
- NCT05753592
- Testing
- Part 1; LOU064 (Remibrutinib), Part 2; LOU064 (Remibrutinib)
- Where
- Hungary
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for…
- Trial name
- KALUMA (NCT05842954)
- Testing
- KLU156, Coartem
- Where
- 32 sites in Burkina Faso, Côte d’Ivoire and 10 more
- Volunteers
- 1,720 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms
177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic…
- Trial name
- PSMAfore (NCT04689828)
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT
- Where
- 72 sites in United States, Austria and 12 more
- Volunteers
- 469 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
The study was designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d.
- Trial name
- APPLAUSE-IgAN (NCT04578834)
- Testing
- LNP023
- Where
- 177 sites in United States, Argentina and 33 more
- Volunteers
- 517 people
- Sponsor
- Novartis Pharmaceuticals
GIST and CML
Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator
This Phase IV, open-label, multicenter roll-over study evaluated the long-term safety of imatinib in patients who had completed a previous Novartis-sponsored imatinib study and were considered by the investigator to continue…
- Trial name
- NCT01742299
- Testing
- imatinib mesylate
- Where
- 29 sites in United States, China and 9 more
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
Renal Angiomyolipoma
A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
The purpose of this prospective study is to assess the safety and efficacy of everolimus in Taiwanese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) .
- Trial name
- NCT05252585
- Testing
- Everolimus
- Where
- 4 sites in Taiwan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation
The study aimed to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation.
- Trial name
- MS-PEKOS (NCT06668324)
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Age-Related Macular Degeneration
A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
The purpose of this study is to assess the effect of Iptacopan to prevent conversion of early or intermediate age-related macular degeneration (AMD) eyes to new incomplete retinal pigment epithelium and outer retinal atrophy…
- Trial name
- NCT05230537
- Testing
- Iptacopan (LNP023)
- Where
- 28 sites in United States, China and 2 more
- Volunteers
- 168 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune and Chronic Inflammatory Diseases
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.
The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.
- Trial name
- NCT07032272
- Testing
- remibrutinib
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia
A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
This was a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral lipid lowering treatment on top of a statin (Oral LLT cohort), newly…
- Trial name
- NCT05362903
- Testing
- Inclisiran
- Where
- 121 sites in Germany
- Volunteers
- 1,868 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Carcinoma
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC)…
- Trial name
- NCT05110196
- Testing
- Capmatinib 150 mg, Capmatinib 200 mg
- Where
- 15 sites in India
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
This was an observational, prospective primary data collection study. The duration of observation was 2 years after study enrolment date.
- Conditions
- Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis
- Trial name
- PROMPT (NCT05155098)
- Testing
- secukinumab
- Where
- 10 sites in Thailand
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with…
- Trial name
- NCT03827798
- Testing
- CFZ533, LYS006, MAS825
- Where
- 36 sites in United States, Austria and 9 more
- Volunteers
- 248 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
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
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
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
Sickle Cell Disease
Crizanlizumab Pregnancy Outcomes Intensive Monitoring
This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP).
- Trial name
- PRIM (NCT07554547)
- Where
- Switzerland
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Polycythemia Vera
A Study of Real-world Use and Effectiveness of Cytoreductive Strategies for the Treatment of Second-line Polycythemia Vera in France
The aim of this study was to assess which cytoreductive treatments are currently administered in standard practice as second-line therapy to patients with polycythemia vera (PV) in France and to find out the reasons physicians…
- Trial name
- VeRavie (NCT07839858)
- Where
- 51 sites in France
- Volunteers
- 237 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC
The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of [177Lu]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese…
- Trial name
- NCT05670106
- Testing
- [177Lu]Lu-PSMA-617, Best supportive/best standard of care (BS/BSOC), 68Ga-PSMA-11
- Where
- 17 sites in China
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
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