Clinical trials: sponsored by Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants
The purpose of this study was to measure the long-term safety and efficacy profile of LTP001 in participants with pulmonary arterial hypertension (PAH).
- Trial name
- NCT05764265
- Testing
- LTP001
- Where
- 12 sites in United States, Argentina and 5 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure
This was a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.
- Trial name
- NCT06142383
- Testing
- XXB750 Low dose, XXB750 Medium Dose, XXB750 High Dose
- Where
- 62 sites in United States, Bulgaria and 10 more
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for…
- Trial name
- EMPATHY (NCT04828161)
- Testing
- ensovibep
- Where
- 48 sites in United States, Hungary and 3 more
- Volunteers
- 407 people
- Sponsor
- Novartis Pharmaceuticals
Tendinopathy
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
- Trial name
- UnchAIN (NCT05569174)
- Testing
- Secukinumab
- Where
- 19 sites in Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast…
- Trial name
- RESONATE (NCT07363434)
- Where
- United States
- Volunteers
- 335 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy
Managed Access Programs for EXV811, Atrasentan
The purpose of this registration is to list Managed Access Programs (MAPs) related to EXV811, Atrasentan
- Trial name
- NCT07319585
- Testing
- Atrasentan
- Sponsor
- Novartis Pharmaceuticals
Myelofibrosis
A Study to Evaluate the Demographics and Treatment Patterns of Myelofibrosis Patients Treated With Ruxolitinib in Turkey
This was a non-interventional retrospective study. Data from patients who were diagnosed with myelofibrosis (MF) (primary MF, post-polycythemia vera MF \& post-essential thrombocythemia MF) and treated with ruxolitinib for at…
- Trial name
- NCT07357441
- Where
- United States
- Volunteers
- 355 people
- 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
Sickle Cell Anemia
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).
- Trial name
- NCT02961218
- Testing
- ACZ885
- Where
- 15 sites in United States, Canada and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC
This was a single-arm, open label, multicenter phase II, study of dabrafenib in combination with trametinib in Chinese participants with BRAF V600E mutation positive, stage IV NSCLC (American joint committee on cancer staging 8th…
- Trial name
- NCT04452877
- Testing
- Dabrafenib, Trametinib
- Where
- 8 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Plasmodium Falciparum Malaria
Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium…
- Trial name
- CALINA (NCT04300309)
- Testing
- artemether:lumefantrine (2.5 mg:30 mg)
- Where
- 3 sites in Burkina Faso, Democratic Republic of the Congo
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.
The purpose of the study was to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switched from their current standard of care treatment (eculizumab or ravulizumab)…
- Trial name
- APPULSE (NCT05630001)
- Testing
- Iptacopan
- Where
- 23 sites in United States, France and 6 more
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent…
- Trial name
- NCT03215758
- Testing
- QAW039
- Where
- 110 sites in United States, Argentina and 8 more
- Volunteers
- 675 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndromes
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R…
- Trial name
- STIMULUS-MDS1 (NCT03946670)
- Testing
- MBG453, Hypomethylating agents
- Where
- 48 sites in United States, Austria and 15 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
The purpose of this study was to assess the pharmacokinetics (PK) of fevipiprant (QAW039) delivered as a chewable tablet (CT) in pediatric asthma subjects aged 6 to < 12 years with asthma.
- Trial name
- NCT03650400
- Testing
- Fevipiprant
- Where
- 6 sites in United States
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Mild Asthma
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in…
- Trial name
- NCT02892344
- Testing
- QMF149 150/80 μg, MF 200 μg
- Where
- 123 sites in Bulgaria, Chile and 20 more
- Volunteers
- 802 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Myeloma
PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed CAR-T cell therapy, manufactured with a new process.
- Trial name
- NCT05172596
- Testing
- PHE885
- Where
- 36 sites in United States, Australia and 12 more
- Volunteers
- 146 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
This trial seeked to extend the preliminary findings of efficacy by evaluating MBG453 in combination with hypomethylating agents (HMA) and also Bcl-2 inhibitor venetoclax.
- Trial name
- STIMULUS-AML1 (NCT04150029)
- Testing
- MBG453, Venetoclax, Azacitidine
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 90 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
- Trial name
- NCT05497284
- Testing
- LTP001, Standard of Care (SoC)
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
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