Clinical trials: sponsored by Novartis Pharmaceuticals
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 13 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Inclisiran Formulation
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a…
- Trial name
- NCT07626281
- Testing
- Inclisiran formulation containing PS80, Currently marketed inclisiran formulation
- Where
- 6 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Plaque Psoriasis, Psoriatic Arthritis
Modifying PEST for Psoriatic Arthritis Screening
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
- Trial name
- ScreenX (NCT06382051)
- Testing
- PEST Screening group
- Where
- 30 sites in Canada
- Volunteers
- 502 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants
A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
The purpose of this study is to assess the effect of multiple doses of phenytoin, a strong cytochrome P450 (CYP)3A4 inducer, and itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetic (PK) profile of DAK539 (hereafter…
- Trial name
- NCT07783503
- Testing
- Pelabresib, Phenytoin, Itraconazole
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Autoimmune and Chronic Inflammatory Diseases
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.
The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.
- Trial name
- NCT07032272
- Testing
- remibrutinib
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Visceral Leishmaniasis, Chagas Disease
A First-in-human, Safety, Tolerability, and Pharmacokinetics Study of LXE408 in Healthy Subjects
The purpose of this first-in-human study is to generate the necessary safety, tolerability, and pharmacokinetics (PK) information that will support further clinical development of LXE408 for the treatment of patients with…
- Trial name
- NCT07809919
- Testing
- LXE408, Iohexol
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Kidney Disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
- Trial name
- NCT07235059
- Testing
- OJR520
- Where
- 2 sites in United States, Germany
- Volunteers
- 112 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
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
Elevated Blood Pressure, Hypertension
HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood…
- Trial name
- NCT07644364
- Testing
- HJB647
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers, Pulmonary Arterial Hypertension
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
- Trial name
- NCT06649110
- Testing
- LTP
- Where
- 87 sites in United States, Argentina and 16 more
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Mild Hypertension
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
This is a randomized, double-blind, placebo-controlled study including Part A single ascending dose (SAD) in healthy subjects and Part B single dose in subjects with mild hypertension.
- Trial name
- NCT06905327
- Testing
- QCZ484
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy
Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
- Trial name
- NCT03945318
- Testing
- BION-1301 Single Dose, BION-1301 Multiple Doses
- Where
- 16 sites in United States, South Korea and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Neuroendocrine Neoplasms
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
The purpose of this study was to evaluate the diagnostic performance of [68Ga]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in…
- Trial name
- NCT06240741
- Testing
- [68Ga]Ga-DOTA-TATE, 68Ge/68Ga Generator
- Where
- 8 sites in Japan
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Tendinopathy
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
- Trial name
- UnchAIN (NCT05569174)
- Testing
- Secukinumab
- Where
- 19 sites in Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Small Cell Lung Carcinoma
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
The purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics (PK), safety, and tolerability of JDQ443 in participants with varying degrees of hepatic impairment.
- Trial name
- NCT05329623
- Testing
- JDQ443
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose.
- Trial name
- NCT05599932
- Testing
- Siremadlin
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled…
- Trial name
- NCT05753592
- Testing
- Part 1; LOU064 (Remibrutinib), Part 2; LOU064 (Remibrutinib)
- Where
- Hungary
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals