Clinical trials: sponsored by Novartis Pharmaceuticals
Polymyalgia Rheumatica
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
- Trial name
- REPLENISH-EXT (NCT06331312)
- Testing
- Secukinumab
- Where
- 85 sites in United States, Argentina and 20 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
Pelacarsen Roll-over Extension Program
This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
- Trial name
- NCT06875973
- Testing
- Pelacarsen (TQJ230)
- Where
- 89 sites in United States, Puerto Rico
- Volunteers
- 599 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants…
- Trial name
- SIRIUS-SLE 1 (NCT05639114)
- Testing
- Ianalumab
- Where
- 135 sites in United States, Argentina and 17 more
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every…
- Trial name
- NCT06042478
- Testing
- Remibrutinib, Omalizumab
- Where
- 110 sites in Argentina, Brazil and 21 more
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease (SCD)
Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis…
- Trial name
- STAND (NCT03814746)
- Testing
- Crizanlizumab (SEG101)
- Where
- 58 sites in United States, Belgium and 19 more
- Volunteers
- 253 people
- Sponsor
- Novartis Pharmaceuticals
Hyperlipoproteinemia (a)
An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
This non-randomized, open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the…
- Trial name
- OLE (NCT05900141)
- Testing
- Pelacarsen
- Where
- 9 sites in Germany
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Sjögrens Disease, Systemic Lupus Erythematosus
Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL…
- Conditions
- Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Trial name
- NCT06293365
- Testing
- VAY736 1ml PFS, VAY736 2 ml PFS, VAY736 2ml AI
- Where
- 37 sites in United States, Argentina and 6 more
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
IgE-Mediated Food Allergy, Peanut Allergy
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin…
- Conditions
- IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy
- Trial name
- NCT07768371
- Testing
- Remibrutinib
- Where
- 18 sites in United States
- Volunteers
- 576 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria (CSU)
A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered…
- Trial name
- RECLAIM (NCT06868212)
- Testing
- Remibrutinib, Dupilumab
- Where
- 121 sites in United States
- Volunteers
- 409 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU)…
- Trial name
- NCT07816328
- Testing
- Remibrutinib, Omalizumab
- Where
- 5 sites in Hong Kong, Japan and 1 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Secondary Progressive Multiple Sclerosis (SPMS)
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
- Trial name
- REMASTER (NCT07225504)
- Testing
- Remibrutinib (blinded), Remibrutinib (Open label)
- Where
- 296 sites in United States, Argentina and 34 more
- Volunteers
- 1,275 people
- Sponsor
- Novartis Pharmaceuticals
Cutaneous Lichen Planus
A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
- Trial name
- ELIPSI (NCT07775924)
- Testing
- GIA632
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 259 people
- Sponsor
- Novartis Pharmaceuticals
Moderate to Severe Psoriatic Arthritis
A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
The purpose of this Phase 2a/b study is: 1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA). 2.
- Trial name
- NCT07801495
- Testing
- DDY391
- Where
- 3 sites in United States
- Volunteers
- 220 people
- Sponsor
- Novartis Pharmaceuticals
Diffuse Cutaneous Systemic Sclerosis
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
- Trial name
- NCT06470048
- Testing
- Ianalumab
- Where
- 106 sites in United States, Argentina and 23 more
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Geographic Atrophy Secondary to Age-related Macular Degeneration
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Trial name
- NCT07441642
- Testing
- FWY003
- Where
- 59 sites in United States, Argentina and 16 more
- Volunteers
- 272 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Pruritus of Unknown Origin
A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).
- Trial name
- NCT07700056
- Testing
- Remibrutinib
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
VEXAS Syndrome
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
The purpose of this study is to evaluate clinical efficacy and safety of arumakimig (MAS825) compared to placebo in patients with Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome.
- Trial name
- NCT07748624
- Testing
- Arumakimig, Oral glucocorticoids
- Where
- 4 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmunity, Inflammation
Secukinumab Open Label Roll-over Extension Protocol
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are…
- Trial name
- NCT04638647
- Testing
- Secukinumab s.c. injection
- Where
- 171 sites in United States, Brazil and 18 more
- Volunteers
- 1,000 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core…
- Trial name
- SIRIUS-SLE LTE (NCT06133972)
- Testing
- Ianalumab
- Where
- 164 sites in United States, Argentina and 27 more
- Volunteers
- 550 people
- Sponsor
- Novartis Pharmaceuticals
Sjögren´s Disease
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
- Trial name
- THALASSA (NCT07621809)
- Testing
- VAY736
- Where
- 33 sites in United States, Australia and 6 more
- Volunteers
- 570 people
- Sponsor
- Novartis Pharmaceuticals
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