Clinical trials: sponsored by Novartis Pharmaceuticals
Non-segmental Vitiligo
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into…
- Trial name
- VITESS (NCT07431177)
- Testing
- GIA632
- Where
- 83 sites in United States, Argentina and 10 more
- Volunteers
- 210 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer
A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of [68Ga]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal…
- Conditions
- Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer, Triple-negative Breast Cancer, Advanced Non-small Cell Lung Cancer
- Trial name
- NCT07801508
- Testing
- [68Ga]Ga-DWJ155
- Where
- 2 sites in Australia, Japan
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients
The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer…
- Trial name
- CATTALYST (NCT07710716)
- Where
- Switzerland
- Volunteers
- 3,000 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the…
- Trial name
- NCT07665437
- Testing
- Remibrutinib
- Where
- 44 sites in United States, Argentina and 7 more
- Volunteers
- 710 people
- Sponsor
- Novartis Pharmaceuticals
Juvenile Psoriatic Arthritis
Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).
The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA
- Trial name
- NCT06751238
- Testing
- Secukinumab
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response [CRR] or…
- Trial name
- SIRIUS-LN ext (NCT06711887)
- Testing
- Ianalumab
- Where
- 51 sites in United States, Brazil and 16 more
- Volunteers
- 348 people
- Sponsor
- Novartis Pharmaceuticals
Early Breast Cancer
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals
Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT07261631
- Testing
- 68Ga-NNS309, 177Lu-DFC413
- Where
- 9 sites in United States, Canada and 5 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Cancer, Castration-Resistant
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617)…
- Trial name
- NCT07047118
- Testing
- JSB462, AAA617
- Where
- 44 sites in United States, Australia and 13 more
- Volunteers
- 138 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Malignancies
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
This drug-drug interaction (DDI) study aims to evaluate the impact of pelabresib at steady-state plasma concentrations on the pharmacokinetic (PK) profile of A) a single dose of repaglinide and a single dose of midazolam, and B)…
- Trial name
- NCT07340190
- Testing
- pelabresib, repaglinide, midazolam
- Where
- 6 sites in France, Italy and 1 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Progressive Metastatic Castrate Resistant Prostate Cancer
An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with…
- Trial name
- TulmiSTAR-01 (NCT07206056)
- Testing
- Tulmimetostat DL1 QD, Tulmimetostat DL2 QD, Tulmimetostat DL3 QD
- Where
- 35 sites in United States, Australia and 12 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Lymphatic Malformations
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.
- Trial name
- EPIK-L1 (NCT05948943)
- Testing
- Alpelisib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.
- Trial name
- MASter-1 (NCT04641442)
- Testing
- MAS825
- Where
- 12 sites in United States, Czechia and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
PIK3CA-related Overgrowth Spectrum (PROS)
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).
- Trial name
- NCT06997588
- Testing
- Alpelisib
- Where
- 39 sites in United States, Australia and 9 more
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals
Progressive Supranuclear Palsy, Corticobasal Degeneration
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of NIO752 in Primary Tauopathies
This is a phase II study intended to evaluate the safety, tolerability and pharmacodynamics of NIO752 in participants with primary tauopathies.
- Conditions
- Progressive Supranuclear Palsy, Corticobasal Degeneration, Frontotemporal Lobar Degeneration, Tauopathies
- Trial name
- NCT07868328
- Testing
- NIO752
- Volunteers
- 48 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
This study aims to evaluate the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C…
- Trial name
- KontRASt-06 (NCT05445843)
- Testing
- JDQ443
- Where
- 45 sites in United States, Argentina and 17 more
- Volunteers
- 95 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Chronic Myeloid
A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany
The aim of this study is to assess the real-world effectiveness of asciminib in Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) patients who were either newly diagnosed or previously…
- Trial name
- ASC2ADHERE (NCT07549516)
- Where
- 69 sites in Germany
- Volunteers
- 380 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
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
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
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