Clinical trials: sponsored by Novartis Pharmaceuticals
Dermatitis, Atopic
A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis
The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636.
- Trial name
- NCT07604324
- Testing
- DCY636
- Where
- Japan
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cryptosporidiosis
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
This study has the purpose to demonstrate prospect of benefit of EDI048 on clinical signs and symptoms of cryptosporidiosis to facilitate trial in target population, pediatric patients.
- Trial name
- CRYPTONITE (NCT07249463)
- Testing
- Cryptosporidium parvum oocysts (ABO809), EDI048
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Polycythemia Vera
Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors
The purpose of this study is to confirm the predictive factors for hydroxyurea (HU) failure (hemoglobin (HGB) <15.5 g/dL (9.62 mmol/L) and red blood cell distribution width (RDW) ≥17%) identified by machine learning in the…
- Trial name
- HU-F-AIM (NCT05853458)
- Testing
- Hydroxyurea
- Where
- 21 sites in Germany
- Volunteers
- 76 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer Metastatic
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
This first-in-human, Phase 1/2, open-label study evaluates the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JSB462 (luxdegalutamide, previously ARV-766) administered as monotherapy and in…
- Trial name
- NCT05067140
- Testing
- ARV-766, Abiraterone, Corticosteroid (e.g., prednisone/prednisolone)
- Where
- 17 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
- Trial name
- NCT05147220
- Testing
- Remibrutinib, Teriflunomide
- Where
- 200 sites in United States, Argentina and 32 more
- Volunteers
- 1,000 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of participants with chronic myeloid leukemia - chronic phase (CML-CP) having previously been treated…
- Trial name
- NCT03106779
- Testing
- Asciminib, Bosutinib
- Where
- 88 sites in United States, Argentina and 23 more
- Volunteers
- 233 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
- Trial name
- NCT05156281
- Testing
- Remibrutinib, Teriflunomide
- Where
- 223 sites in United States, Argentina and 25 more
- Volunteers
- 1,007 people
- Sponsor
- Novartis Pharmaceuticals
Ankylosing Spondylitis
Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.
- Trial name
- ONSET (NCT06905288)
- Testing
- Secukinumab
- Where
- 3 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Diseases, Kidney Diseases, Chronic
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN).
- Conditions
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis
- Trial name
- NCT06858319
- Testing
- zigakibart
- Where
- 26 sites in United States, Argentina and 7 more
- Volunteers
- 220 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria
NIS PDC the Efficacy and Safety of Iptacopan in Adults in Routine Clinical Practice
This is a prospective, non-interventional, multicenter study to evaluate the efficacy and safety of iptacopan in patients with PNH in real-world settings in Russia.
- Trial name
- PRIORITY- PNH (NCT07036718)
- Where
- 5 sites in Russia
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
Essential Hypertension
Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
This study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data…
- Trial name
- NCT06604897
- Where
- United States
- Volunteers
- 1,405 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American…
- Trial name
- NCT07760714
- Where
- United States
- Volunteers
- 945 people
- Sponsor
- Novartis Pharmaceuticals
Graft-versus-Host Disease
A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD)…
- Trial name
- NCT05621733
- Testing
- ruxolitinib
- Where
- 14 sites in South Korea
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
- Trial name
- ENESTfreedom (NCT01784068)
- Testing
- Nilotinib followed by treatment-free
- Where
- 113 sites in United States, Argentina and 17 more
- Volunteers
- 215 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS).
- Trial name
- KATHAROS (NCT06444113)
- Testing
- Ofatunumab
- Where
- 15 sites in United States, Germany and 3 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)
A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients.
- Trial name
- ENESTop (NCT01698905)
- Testing
- nilotinib
- Where
- 62 sites in United States, Argentina and 16 more
- Volunteers
- 163 people
- Sponsor
- Novartis Pharmaceuticals
Generalized Myasthenia Gravis
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.
The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment.
- Trial name
- NCT06517758
- Testing
- Iptacopan
- Where
- 116 sites in United States, Argentina and 16 more
- Volunteers
- 146 people
- Sponsor
- Novartis Pharmaceuticals
IGA Nephropathy
A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United States
The aim of this study was to characterize real-world treatment patterns, including therapy sequences, escalation, and duration, and treatment outcomes in IgA nephropathy (IgAN) patients in the United States (US).
- Trial name
- NCT07757048
- Where
- United States
- Volunteers
- 6,286 people
- Sponsor
- Novartis Pharmaceuticals
Myocardial Infarction
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia.
- Trial name
- STREAMLINE (NCT07142265)
- Where
- 18 sites in Russia
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Aplastic Anemia
A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia
This is a phase II, open label, multi-center, intra-patient dose escalation study to characterize the pharmacokinetics (PK) after oral administration of eltrombopag in combination with immunosuppressive therapy in pediatric…
- Trial name
- NCT03025698
- Testing
- Eltrombopag, hATG, CsA
- Where
- 20 sites in United States, Hong Kong and 4 more
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
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