Clinical trials: sponsored by Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
An Epidemiology Study of Treatment Resistant Depression in the United States (US)
The purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and…
- Trial name
- NCT03109002
- Volunteers
- 200,000 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
- Trial name
- NCT03170518
- Testing
- Canagliflozin 100 mg, Canagliflozin 300 mg
- Where
- 106 sites in United States, Brazil and 8 more
- Volunteers
- 171 people
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
- Trial name
- Envision (NCT03664232)
- Testing
- JNJ-42165279
- Where
- 9 sites in United States
- Volunteers
- 78 people
- Sponsor
- Janssen Research & Development, LLC
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Syncytial Virus Infections
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or…
- Trial name
- NCT03656510
- Testing
- JNJ-53718678
- Where
- 169 sites in United States, Argentina and 20 more
- Volunteers
- 246 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 1
A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
- Trial name
- T1GER (NCT02846545)
- Testing
- Golimumab
- Where
- 33 sites in United States
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Syncytial Viruses
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory…
- Trial name
- NCT04068792
- Testing
- RSV Mobile Application, JNJ-53718678 2.5 mg/kg, JNJ-53718678 3 mg/kg
- Where
- 10 sites in Argentina, Belgium and 3 more
- Volunteers
- 22 people
- Sponsor
- Janssen Research & Development, LLC
Influenza A
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
- Trial name
- NCT03381196
- Testing
- Pimodivir 600 mg, SOC Treatment
- Where
- 427 sites in United States, Argentina and 36 more
- Volunteers
- 553 people
- Sponsor
- Janssen Research & Development, LLC
HIV
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or…
- Trial name
- NCT04012931
- Testing
- Rilpivirine, ARV Background Regimen
- Where
- 14 sites in Italy, Portugal and 4 more
- Volunteers
- 26 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Influenza A
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
- Trial name
- NCT03376321
- Testing
- Pimodivir 600 mg, SOC Treatment
- Where
- 269 sites in United States, Argentina and 36 more
- Volunteers
- 334 people
- Sponsor
- Janssen Research & Development, LLC
Pre-Symptomatic Type 1 Diabetes
A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
The purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D).
- Trial name
- NCT03298542
- Testing
- Golimumab
- Where
- 8 sites in United States, Finland and 1 more
- Volunteers
- 8 people
- Sponsor
- Janssen Research & Development, LLC
Adenomatous Polyposis Coli
Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis
The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study…
- Trial name
- NCT04948398
- Testing
- Guselkumab
- Sponsor
- Janssen Research & Development, LLC
Epilepsy
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED)…
- Trial name
- NCT01689649
- Testing
- Topiramate
- Where
- 2 sites in Vietnam
- Volunteers
- 139 people
- Sponsor
- Janssen Research & Development, LLC
Human Immunodeficiency Virus (HIV)
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.
- Trial name
- NCT05197075
- Testing
- DRV/COBI FDC
- Where
- 6 sites in United States, South Africa and 1 more
- Volunteers
- 15 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 1
Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults
This is a Single Patient Investigational New Drug (IND) to golimumab subcutaneous (SC) for the treatment of recently diagnosed Stage 3 type-1 diabetes mellitus (T1D) in children and young adults.
- Trial name
- NCT03945903
- Testing
- Golimumab
- Where
- United States
- Sponsor
- Janssen Research & Development, LLC
Lymphoma, Non-Hodgkin
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination…
- Trial name
- NCT02703272
- Testing
- Ibrutinib, Rituximab, Ifosfamide
- Where
- 76 sites in United States, Belgium and 18 more
- Volunteers
- 72 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Castration-resistant Prostate Cancer, Metastatic Breast Cancer
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.
- Trial name
- NCT01517802
- Testing
- Abiraterone acetate, Prednisone
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 32 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis
- Trial name
- CADMUS Jr (NCT02698475)
- Testing
- Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 44 people
- Sponsor
- Janssen Research & Development, LLC