Clinical trials: sponsored by Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung, Melanoma
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior…
- Conditions
- Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma, Microsatellite Stable Colorectal Cancer
- Trial name
- NCT03891953
- Testing
- DKY709, PDR001
- Where
- 9 sites in United States, Germany and 4 more
- Volunteers
- 98 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
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with…
- Trial name
- NCT03827798
- Testing
- CFZ533, LYS006, MAS825
- Where
- 36 sites in United States, Austria and 9 more
- Volunteers
- 248 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
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
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
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
Papulopustular Rosacea
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular…
- Trial name
- NCT07681271
- Testing
- LOU064
- Where
- 12 sites in United States, Bulgaria and 6 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP).
- Trial name
- NCT07498426
- Testing
- NIO752
- Where
- 64 sites in United States, Australia and 10 more
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Neuroendocrine Prostate Cancer
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide…
- Trial name
- NCT06379217
- Testing
- [68Ga]Ga-PSMA-11, [68Ga]GA-DOTA-TATE, [68Ga]Ga-NeoB
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 31 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
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
Chronic Inducible Urticaria
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).
- Trial name
- NCT05976243
- Testing
- Remibrutinib
- Where
- 130 sites in United States, Argentina and 26 more
- Volunteers
- 362 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after…
- Trial name
- VAY RE-HIT (NCT07039422)
- Testing
- Ianalumab
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07811908)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 13 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 120 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
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
Lupus Nephritis
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
- Trial name
- SIRIUS-LN (NCT05126277)
- Testing
- ianalumab s.c. q4w, ianalumab s.c. q12w
- Where
- 145 sites in United States, Argentina and 25 more
- Volunteers
- 452 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