Clinical trials: sponsored by Novartis Pharmaceuticals
Moderate to Severe Psoriatic Arthritis
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
The purpose of this 1-year open-label extension study is to characterize the longer-term safety and tolerability of DDY391 and to assess the durability of clinical response in participants with Psoriatic Arthritis (PsA) who have…
- Trial name
- NCT07923773
- Testing
- DDY391
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
Secondary Malignancies of T-cell Origin
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
The study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after…
- Trial name
- Lythesia (NCT07378969)
- Where
- 4 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Berger Disease, Bergers Disease
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to <18 years with primary immunoglobulin A nephropathy (IgAN).
- Conditions
- Berger Disease, Bergers Disease, IgA Nephropathy, Immunoglobulin A Nephropathy
- Trial name
- ADVANCE (NCT07498335)
- Testing
- Drug: Atrasentan
- Where
- 23 sites in United States, China and 6 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis and Systemic Lupus Erythematosus
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this First-In-Human (FIH), Phase 1, open-label, ascending dose study is to determine safety and tolerability of DKB903, in participants with Rheumatoid Arthritis (RA) and participants with Systemic Lupus…
- Trial name
- NCT07923747
- Testing
- DKB903
- Volunteers
- 90 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical…
- Trial name
- VICTORION REAL (NCT05399992)
- Testing
- Inclisiran
- Where
- 40 sites in Austria, China and 6 more
- Volunteers
- 847 people
- Sponsor
- Novartis Pharmaceuticals
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF)…
- Conditions
- Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF), Post-essential Thrombocythemia Myelofibrosis (PET-MF)
- Trial name
- MANIFEST-3 (NCT07357727)
- Testing
- Pelabresib, Ruxolitinib
- Where
- 164 sites in United States, Argentina and 20 more
- Volunteers
- 460 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously…
- Trial name
- KontRASt-02 (NCT05132075)
- Testing
- JDQ443, docetaxel
- Where
- 51 sites in United States, Argentina and 23 more
- Volunteers
- 95 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
Cancer
Pan Tumor Rollover Study
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
- Trial name
- NCT03899155
- Testing
- Nivolumab, Ipilimumab, Cabozantinib
- Where
- 410 sites in United States, Argentina and 36 more
- Volunteers
- 1,500 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast…
- Trial name
- NCT06075758
- Testing
- ribociclib
- Where
- 3 sites in Jordan, Oman and 1 more
- Volunteers
- 358 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular Age-related Macular Degeneration
Regulatory Post-Marketing Surveillance Study for Brolucizumab
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
- Trial name
- NCT04985487
- Testing
- brolucizumab
- Where
- 45 sites in South Korea
- Volunteers
- 3,369 people
- Sponsor
- Novartis Pharmaceuticals
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who…
- Trial name
- VAY2EXPLORE (NCT07421167)
- Testing
- ianalumab, thrombopoietin receptor agonist (TPO-RA)
- Where
- 23 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Primary Prevention of Atherosclerotic Cardiovascular Disease
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at…
- Trial name
- NCT05739383
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 983 sites in United States, Argentina and 40 more
- Volunteers
- 14,012 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Prospective, non-interventional study in patients with chronic spontaneous urticaria (CSU) where the treatment decision prior enrollment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- REASSERT (NCT07920315)
- Volunteers
- 578 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer's Disease
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early AD followed by an Extension.
- Trial name
- NCT07094516
- Testing
- VHB937
- Where
- 73 sites in United States, Australia and 13 more
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Squamous Cell of Head and Neck, HPV Positive Oropharyngeal Squamous Cell Carcinoma
Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.
- Conditions
- Carcinoma, Squamous Cell of Head and Neck, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Hypopharyngeal Cancer, Early Invasive Cervical Squamous Cell Carcinoma
- Trial name
- NCT02113878
- Testing
- BKM120, Cisplatin, Intensity-modulated radiotherapy (IMRT)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Dana-Farber Cancer Institute
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
EGFR-mutant Non-small Cell Lung Cancer
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced Epidermal growth factor…
- Trial name
- NCT03333343
- Testing
- EGF816, trametinib, ribociclib
- Where
- 11 sites in Canada, Germany and 4 more
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
C3G
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
- Trial name
- APPEAR-C3G (NCT04817618)
- Testing
- iptacopan
- Where
- 88 sites in United States, Argentina and 17 more
- Volunteers
- 98 people
- Sponsor
- Novartis Pharmaceuticals
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