Clinical trials: sponsored by Novartis Pharmaceuticals
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in…
- Trial name
- VAYHIT1 (NCT05653349)
- Testing
- Ianalumab, Corticosteroids
- Where
- 111 sites in United States, Argentina and 23 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Non-Hodgkin Lymphoma
Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of…
- Trial name
- BELINDA (NCT03570892)
- Testing
- Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy, Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 330 people
- Sponsor
- Novartis Pharmaceuticals
Allergy, Peanut
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts.
- Trial name
- NCT05432388
- Testing
- LOU064
- Where
- 24 sites in United States
- Volunteers
- 76 people
- Sponsor
- Novartis Pharmaceuticals
Acute Lymphoblastic Leukemia
A Real-world Study of Asciminib Effectiveness in Philadelphia Positive Acute Lymphoblastic Leukemia Patients
The aim of this study was to collect existing information from the medical charts of patients enrolled in the ongoing asciminib Managed Access Program (MAP) to better understand the effectiveness and safety of asciminib when used…
- Trial name
- ASCERTAIN (NCT07644351)
- Where
- 18 sites in United States, Australia and 10 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Retinitis Pigmentosa
A First-in-human, Proof of Concept Study of CPK850 in Patients With RLBP1 Retinitis Pigmentosa
The purpose of this first-in-human study is to explore the maximum tolerated dose (MTD) of CPK850 as determined by the single ascending dose ranging portion of the study.
- Trial name
- NCT03374657
- Testing
- CPK850
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- 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
Relapsing Multiple Sclerosis (RMS)
Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine…
- Trial name
- CHRONOS (NCT06486779)
- Testing
- Ofatumumab
- Where
- 15 sites in Greece
- Volunteers
- 160 people
- Sponsor
- Novartis Pharmaceuticals
Hematologic Malignancy, Solid Tumor
An Extension Study for Patients Previously Enrolled in Studies With Pelabresib
The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies.
- Conditions
- Hematologic Malignancy, Solid Tumor, Advanced Malignancies
- Trial name
- NCT06401356
- Testing
- Pelabresib
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever, Still Disease
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including…
- Conditions
- Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still Disease
- Trial name
- NCT07517250
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- Novartis Pharmaceuticals
Graft vs. Host Disease, Chronic Graft vs. Host Disease
Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
- Conditions
- Graft vs. Host Disease, Chronic Graft vs. Host Disease, Corticosteroid-refractory Chronic Graft vs. Host Disease
- Trial name
- NCT06824103
- Testing
- Ruxolitinib
- Where
- 22 sites in China
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate…
- Trial name
- PSMAddition (NCT04720157)
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT
- Where
- 167 sites in United States, Austria and 17 more
- Volunteers
- 1,140 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are…
- Trial name
- NCT04657822
- Testing
- Crizanlizumab
- Where
- 31 sites in United States, Belgium and 9 more
- Volunteers
- 130 people
- Sponsor
- Novartis Pharmaceuticals
Graft-Versus-Host Disease
A Study of Ruxolitinib in Patients With Graft-Versus Host Disease
This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice.
- Trial name
- NCT07594587
- Where
- Japan
- Volunteers
- 395 people
- Sponsor
- Novartis Pharmaceuticals
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation
The Drugs Controller General of India (DCGI) has granted approval for Asciminib film-coated 40 mg tablets on 20 Oct 2023 with the condition to perform a Phase IV clinical study in Indian patients with Philadelphia…
- Trial name
- ASC4INDIA (NCT06427811)
- Testing
- Asciminib
- Where
- 10 sites in India
- Volunteers
- 85 people
- Sponsor
- Novartis Pharmaceuticals
Atypical Hemolytic Uremic Syndrome
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.
- Trial name
- NCT05795140
- Testing
- Iptcaopan 200 mg
- Where
- 9 sites in Brazil, China and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter…
- Trial name
- NCT05803941
- Testing
- AAA617
- Where
- 54 sites in United States, Austria and 9 more
- Volunteers
- 700 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy, Immunoglobulin A Nephropathy
Atrasentan in Patients With IgA Nephropathy
The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.
- Trial name
- ALIGN (NCT04573478)
- Testing
- Atrasentan, Zigakibart
- Where
- 135 sites in United States, Argentina and 18 more
- Volunteers
- 404 people
- Sponsor
- Novartis Pharmaceuticals
Myocardial Infarction
A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients
The purpose of this study was to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation of the proposed education…
- Trial name
- DEDUCA-CZ (NCT06548555)
- Testing
- systematic educational intervention
- Where
- 5 sites in Czechia
- Volunteers
- 121 people
- Sponsor
- Novartis Pharmaceuticals
Biallelic RPE65 Mutation-associated Retinal Dystrophy
Study of Efficacy and Safety of Voretigene Neparvovec in Japanese Patients With Biallelic RPE65 Mutation-associated Retinal Dystrophy
The purpose of this study is to provide safety and efficacy data for voretigene neparvovec, administered as subretinal injection, in Japanese patients with biallelic RPE65 mutation-associated retinal dystrophy.
- Trial name
- NCT04516369
- Testing
- voretigene neparvovec
- Where
- Japan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
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