Clinical trials: sponsored by Janssen Research & Development, LLC
Heart Failure
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City…
- Trial name
- CHIEF-HF (NCT04252287)
- Testing
- Canagliflozin 100 mg
- Where
- 18 sites in United States
- Volunteers
- 476 people
- Sponsor
- Janssen Research & Development, LLC
Arthroplasty, Replacement, Knee
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or…
- Trial name
- AXIOMATIC-TKR (NCT03891524)
- Testing
- JNJ-70033093 25 mg, JNJ-70033093 50 mg, JNJ-70033093 100 mg
- Where
- 117 sites in United States, Argentina and 16 more
- Volunteers
- 1,242 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab
The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous…
- Trial name
- NCT03871829
- Testing
- Carfilzomib 20 mg/m^2, Carfilzomib 70 mg/m^2, Dexamethasone 40 mg
- Where
- 108 sites in United States, Belgium and 11 more
- Volunteers
- 88 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
Lupus Nephritis
A Study of Guselkumab in Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
- Trial name
- ORCHID-LN (NCT04376827)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Standard-of-care treatment
- Where
- 60 sites in United States, Argentina and 7 more
- Volunteers
- 33 people
- Sponsor
- Janssen Research & Development, LLC
Myelodysplastic Syndromes
Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic…
- Trial name
- NCT03011034
- Testing
- Talacotuzumab, Daratumumab
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Neoplasms
A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have…
- Trial name
- NCT01715285
- Testing
- Abiraterone acetate, Prednisone, Androgen deprivation therapy (ADT)
- Where
- 208 sites in Argentina, Australia and 31 more
- Volunteers
- 1,209 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Syncytial Virus Infections
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV…
- Trial name
- NCT03379675
- Testing
- JNJ-53718678 500 mg, JNJ-53718678 80 mg
- Where
- 124 sites in United States, Argentina and 17 more
- Volunteers
- 72 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease, Colitis
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to…
- Conditions
- Crohn's Disease, Colitis, IBD, Inflammatory Bowel Disease
- Trial name
- NCT01369355
- Testing
- Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV, Ustekinumab 90 mg SC q12w
- Where
- 220 sites in United States, Australia and 24 more
- Volunteers
- 1,282 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer…
- Trial name
- NCT00887198
- Testing
- Abiraterone acetate, Prednisone
- Where
- 134 sites in United States, Australia and 9 more
- Volunteers
- 1,088 people
- Sponsor
- Janssen Research & Development, LLC
Atopic Dermatitis, Eczema
A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
- Trial name
- NCT04021862
- Testing
- Bermekimab Monoclonal Antibody
- Where
- 17 sites in United States
- Volunteers
- 87 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week…
- Trial name
- PRISM (NCT04102111)
- Testing
- JNJ-67864238
- Where
- 63 sites in United States, Argentina and 5 more
- Volunteers
- 48 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
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
Hepatitis C, Chronic
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or…
- Trial name
- NCT02262728
- Testing
- Simeprevir, Daclatasvir, Sofosbuvir
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Janssen Research & Development, LLC
Hidradenitis Suppurativa
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).
- Trial name
- NOVA (NCT03628924)
- Testing
- Guselkumab dose 1, Guselkumab dose 2, Guselkumab dose 3
- Where
- 45 sites in United States, Canada and 4 more
- Volunteers
- 184 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
Psoriatic Arthritis
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).
- Trial name
- NCT02319759
- Testing
- Guselkumab, Ustekinumab
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 149 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR), as defined by the…
- Trial name
- NCT02874742
- Testing
- Lenalidomide, Bortezomib, Dexamethasone
- Where
- 36 sites in United States
- Volunteers
- 224 people
- Sponsor
- Janssen Research & Development, LLC