Clinical trials: sponsored by 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
Plaque Psoriasis, Metabolic Dysfunction-Associated Steatotic Liver Disease
A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis [PsA]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine…
- Trial name
- SEC-HOPE (NCT07683065)
- Where
- 7 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS
This study aims to better understand how Bruton's tyrosine kinase (BTK) inhibition with remibrutinib works in hidradenitis suppurativa (HS), a complex inflammatory disease with different types of lesions.
- Trial name
- NCT07855276
- Testing
- LOU064
- Where
- 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
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
- RECHARGE-2 (NCT06840392)
- Testing
- Remibrutinib Dose A, Remibrutinib Dose B
- Where
- 129 sites in United States, Argentina and 17 more
- Volunteers
- 565 people
- Sponsor
- Novartis Pharmaceuticals
Chagas Disease
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
- Trial name
- NCT06632600
- Testing
- LXE408, Benznidazole
- Where
- 22 sites in United States, Argentina and 2 more
- Volunteers
- 130 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms, Castration-Resistant
A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway…
- Trial name
- NCT07677267
- Where
- United States
- Volunteers
- 1,067 people
- Sponsor
- Novartis Pharmaceuticals
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as…
- Trial name
- NCT07226986
- Testing
- AMO959, AAA617, Enzalutamide
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less…
- Trial name
- NCT05776927
- Testing
- QVM149, Salmeterol Xinafoate / Fluticasone Propionate
- Where
- 22 sites in Argentina, France and 7 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by…
- Trial name
- NCT05677451
- Testing
- LOU064 (blinded)
- Where
- 49 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic…
- Trial name
- AcTFirst (NCT06855277)
- Testing
- AAA817, ARPI, Standard of Care
- Where
- 106 sites in United States, Australia and 10 more
- Volunteers
- 940 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma
The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age…
- Trial name
- NCT05562466
- Testing
- QMF149, Budesonide
- Where
- 65 sites in Argentina, Austria and 15 more
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Radioiodine-refractory Differentiated Thyroid Cancer
A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients
This study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R…
- Trial name
- NCT07770074
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Artery Disease
Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP
The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable…
- Trial name
- NCT07830719
- Testing
- YMI024
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 180 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
- 18 sites in United States, China and 5 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Immune Thrombocytopenia
A Real-world Study of Treatment Patterns and Outcomes in Primary Immune Thrombocytopenia Patients Treated With Eltrombopag
This study aims to describe the treatment patterns and clinical outcomes of treatment with eltrombopag in primary immune thrombocytopenia (ITP) patients treated with prior corticosteroid therapy.
- Trial name
- NCT07587723
- Where
- Switzerland
- Volunteers
- 150 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
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
Prostatic Neoplasms, Castration-Resistant
A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer
The aim of this study is to assess treatment patterns, clinical outcomes, and patient characteristics among adults with metastatic castration-resistant prostate cancer (mCRPC) in the United States (US) real-world clinical…
- Trial name
- NCT07677254
- Where
- United States
- Volunteers
- 17,111 people
- Sponsor
- Novartis Pharmaceuticals
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