Clinical trials: sponsored by 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
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
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
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
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
- 40 sites in United States, Australia and 9 more
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Prostate Cancer
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer
- Trial name
- PULSE (NCT07484269)
- Where
- Switzerland
- Volunteers
- 753 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)
The primary purpose is to address critical evidence in the treatment landscape for Spinal Muscular Atrophy (SMA), specifically focusing on the intrathecal formulation of onasemnogene abeparvovec-brve (ITVISMA®). U.S.
- Trial name
- NCT07448610
- Testing
- Onasemnogene Abeparvovec-brve
- Where
- 6 sites in United States
- Volunteers
- 36 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
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Malaria
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
This non-interventional qualitative study will examine factors that influence the adoption of a novel malaria treatment in Côte d'Ivoire, Ghana, and Rwanda.
- Trial name
- NCT07896746
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Still's Disease, Including SJIA and AOSD, With MAS or ILD Complications
Managed Access Programs for MAS825, Arumakimig
The purpose of this registration is to list Managed Access Programs (MAPs) related to MAS825, arumakimig
- Trial name
- NCT07889310
- Testing
- Arumakimig
- 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
Primary Myelofibrosis, Polycythemia Vera
CINC424A2X01B Rollover Protocol
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study…
- Conditions
- Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia
- Trial name
- NCT02386800
- Testing
- ruxolitinib, panobinostat
- Where
- 97 sites in Australia, Belgium and 23 more
- Volunteers
- 279 people
- Sponsor
- Novartis Pharmaceuticals
Nephropathic Cystinosis
DFT383 in Pediatric Participants With Nephropathic Cystinosis
An open-label, multi-center, phase I/II study to assess the safety, tolerability and efficacy of DFT383 in pediatric participants with nephropathic cystinosis, followed by a long-term extension phase.
- Trial name
- CYStem (NCT06910813)
- Testing
- DFT383
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Indication of the Parent Protocol
Remibrutinib Open Label Roll-over Post-trial Access Protocol
Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a…
- Trial name
- NCT07456891
- Testing
- Remibrutinib
- Where
- 43 sites in Bulgaria, Canada and 7 more
- Volunteers
- 650 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
Acute Lymphoblastic Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
Multi-center, open-label, single arm study of asciminib in participants aged ≥1 year to ≤30 years old with r/r Ph+ or ABL-class Ph-like ALL. This study will have 2 parts: Part 1 dose escalation and Part 2 dose expansion.
- Conditions
- Acute Lymphoblastic Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- Trial name
- NCT07387926
- Testing
- Asciminib Adult formulation, Asciminib Pediatric formulation, Dexamethasone
- Where
- 4 sites in Australia, Israel and 2 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult…
- Trial name
- SPARKLE (NCT06439082)
- Testing
- Crizanlizumab
- Where
- 36 sites in United States, Brazil and 3 more
- Volunteers
- 354 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
A Real-World Medical Chart Review of Spinal Muscular Atrophy Patients Treated With Onasemnogene Abeparvovec in Saudi Arabia
The aim of this retrospective medical chart review is to describe the clinical outcomes, clinical characteristics, and demographics of patients with spinal muscular atrophy (SMA) type 1 treated with onasemnogene abeparvovec (OA)…
- Trial name
- SMA-REAL (NCT07737756)
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals