Clinical trials: active, sponsored by Novartis Pharmaceuticals
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,464 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension
- Trial name
- NCT06857955
- Testing
- Saline, QCZ484
- Where
- 72 sites in United States, Japan and 1 more
- Volunteers
- 396 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
- 145 sites in United States, Argentina and 20 more
- Volunteers
- 460 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined…
- Trial name
- KontRASt-R (NCT07468071)
- Testing
- Opnurasib, TNO155, trametinib
- Where
- 21 sites in Belgium, Canada and 8 more
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care…
- Trial name
- NCT07570979
- Testing
- INR731, Enzalutamide, Abiraterone
- Where
- 13 sites in United States, Australia and 6 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma, Non Small Cell Lung Cancer
Dabrafenib and/or Trametinib Rollover Study
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have…
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers
- Trial name
- NCT03340506
- Testing
- dabrafenib, trametinib
- Where
- 38 sites in United States, Argentina and 13 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- 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
- 19 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region.
- Trial name
- ASC4Young (NCT07681258)
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
A Study of the Safety and Effectiveness of Onasemnogene Abeparvovec (Zolgensma) Intrathecal Injection in Spinal Muscular Atrophy Patients
This study aims to assess the safety and effectiveness of onasemnogene abeparvovec intrathecal injection in spinal muscular atrophy (SMA) patients in clinical practice in Japan.
- Trial name
- NCT07767890
- Where
- 4 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan…
- Trial name
- NCT05838768
- Testing
- HRO761, pembrolizumab, irinotecan
- Where
- 28 sites in United States, Belgium and 13 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasm
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive…
- Trial name
- PSMACare (NCT05849298)
- Testing
- AAA617, AAA517, Piflufolastat F 18
- Where
- 31 sites in United States, Brazil and 9 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Oligometastatic Prostate Cancer (OMPC)
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary…
- Trial name
- PSMA-DC (NCT05939414)
- Testing
- AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg)
- Where
- 144 sites in United States, Argentina and 25 more
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer (mCRPC)
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and…
- Trial name
- PSMAndARPI (NCT06894511)
- Testing
- AAA617, ARPI: Abiraterone, ARPI: Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 7 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
- 97 people
- Sponsor
- Novartis Pharmaceuticals
Immunoglobulin A Nephropathy (IgAN)
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
- Trial name
- SHIFT (NCT07146906)
- Testing
- zigakibart
- Where
- 30 sites in United States, Brazil and 9 more
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates
The aim of this study is to evaluate the real-world effectiveness of ARNi (sacubitril/valsartan) therapy and antihypertensive monotherapy in reducing blood pressure in hypertensive patients residing in the United Arab Emirates.
- Trial name
- REAL-HTN (NCT07465666)
- Where
- 4 sites in United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndromes
Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence
This study is designed to evaluate the efficacy and safety of eltrombopag monotherapy in Japanese adult patients with platelet transfusion-dependent lower-risk Myelodysplastic syndromes (LR-MDS).
- Trial name
- NCT04797000
- Testing
- Eltrombopag
- Where
- 20 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or…
- Conditions
- Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma, Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial
- Trial name
- NCT05544929
- Testing
- KFA115, pembrolizumab
- Where
- 18 sites in United States, Canada and 10 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
- Trial name
- NCT05885555
- Testing
- Ianalumab
- Where
- 24 sites in United States, Argentina and 11 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals