Clinical trials: sponsored by Novartis Pharmaceuticals
Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c.
- Trial name
- NCT06267560
- Testing
- TQJ230
- Where
- 96 sites in United States, Puerto Rico
- Volunteers
- 422 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
- Trial name
- NCT01892722
- Testing
- Interferon beta-1a, Fingolimod
- Where
- 73 sites in United States, Australia and 23 more
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2…
- Trial name
- ELEGANCE (NCT06930859)
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 42 sites in Russia
- Volunteers
- 2,766 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis (RMS)
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing…
- Trial name
- FILIOS (NCT06869785)
- Testing
- Ofatumumab approved dose, Ofatumumab new dose
- Where
- 63 sites in United States, Puerto Rico
- Volunteers
- 196 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Vascular Disease, Heterozygous Familial Hypercholesterolemia
Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
- Trial name
- INSPIRE (NCT06958315)
- Testing
- Inclisiran
- Where
- 20 sites in Spain
- Volunteers
- 219 people
- Sponsor
- Novartis Pharmaceuticals
Atypical Hemolytic Uremic Syndrome
Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy
The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy.
- Trial name
- APPELHUS (NCT04889430)
- Testing
- Iptacopan
- Where
- 36 sites in United States, Brazil and 6 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
- Trial name
- NCT03955445
- Testing
- LNP023
- Where
- 53 sites in United States, Argentina and 15 more
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Lipoprotein Disorder
A Study of DII235 in Adults With Elevated Lipoprotein(a)
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
- Trial name
- NCT07235046
- Testing
- DII235, Saline
- Where
- 63 sites in United States, China and 2 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria
This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed…
- Trial name
- NCT04747613
- Testing
- Iptacopan
- Where
- 60 sites in United States, Brazil and 15 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib.
- Trial name
- NCT07642557
- Where
- Germany
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
Juvenile Idiopathic Arthritis
Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis
This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis
- Trial name
- Toddler (NCT06431750)
- Testing
- Secukinumab
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients
The purpose of this open-label, single arm, multicenter, phase 3 study is to assess the pharmacokinetics of iptacopan in pediatric patients and to assess whether iptacopan is safe and well tolerated when used for the treatment of…
- Trial name
- NCT06934967
- Testing
- LNP023
- Where
- 15 sites in United States, Brazil and 4 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolaemia, Hypercholesterolaemia
Specified Drug-use Survey of Leqvio for s.c. Injection.
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
- Trial name
- NCT06275724
- Testing
- inclisiran
- Where
- 107 sites in Japan
- Volunteers
- 585 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse
The aim of this study was to describe real-world treatment patterns after relapsing on platform disease-modifying therapies (DMTs) in terms of proportions of patients who remain on platform DMTs or escalate to high-efficacy DMTs…
- Trial name
- NCT07743281
- Where
- United States
- Volunteers
- 753 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A 24-week rPMS Study in Real-world Setting for Enerzair
This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under…
- Trial name
- NCT05274425
- Testing
- Enerzair 150/50/80 μg, Enerzair 150/50/160 μg
- Where
- 21 sites in South Korea
- Volunteers
- 683 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation (AF)
Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in…
- Trial name
- LILAC-TIMI 76 (NCT07739888)
- Testing
- Abelacimab
- Volunteers
- 2,500 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Characterizing the Use of Ofatumumab in a Real World Setting
This is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact…
- Trial name
- EAFToS (NCT05090033)
- Testing
- ofatumumab
- Where
- 7 sites in Australia
- Volunteers
- 103 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolaemia
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in…
- Trial name
- NCT07610278
- Testing
- QCZ484, Inclisiran
- Where
- 29 sites in United States
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension (HTN)
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the…
- Trial name
- NCT07543120
- Testing
- QCZ484
- Where
- 25 sites in United States, Japan and 1 more
- Volunteers
- 323 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.
- Trial name
- AIOLOS (NCT05344469)
- Testing
- ofatumumab, glatiramer acetate, interferon β1
- Where
- 141 sites in Germany
- Volunteers
- 800 people
- Sponsor
- Novartis Pharmaceuticals