Clinical trials: completed, sponsored by Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia…
- Trial name
- NCT04899336
- Testing
- ExPEC9V
- Where
- 374 sites in United States, Australia and 19 more
- Volunteers
- 17,797 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Advanced Solid Tumor
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations…
- Trial name
- RAGNAR (NCT04083976)
- Testing
- Erdafitinib
- Where
- 179 sites in United States, Argentina and 13 more
- Volunteers
- 316 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by…
- Trial name
- SOLSTICE (NCT04936308)
- Testing
- Guselkumab
- Where
- 169 sites in United States, Argentina and 12 more
- Volunteers
- 453 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure…
- Trial name
- UNITI Jr (NCT04673357)
- Testing
- Ustekinumab
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 101 people
- Sponsor
- Janssen Research & Development, LLC
Prostatic Neoplasms
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 [PCWG2]) of apalutamide versus placebo in Chinese participants…
- Trial name
- NCT04108208
- Testing
- Apalutamide, Androgen-deprivation Therapy (ADT)
- Where
- 27 sites in China
- Volunteers
- 75 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha…
- Trial name
- AFFINITY (NCT05071664)
- Testing
- Guselkumab, Golimumab
- Where
- 82 sites in United States, Denmark and 8 more
- Volunteers
- 91 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis D, Chronic
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.
- Trial name
- REEF-D (NCT04535544)
- Testing
- JNJ-73763989, Entecavir (ETV) monohydrate, Tenofovir disoproxil
- Where
- 61 sites in United States, Australia and 13 more
- Volunteers
- 52 people
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis, Scalp Psoriasis
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by…
- Trial name
- VISIBLE (NCT05272150)
- Testing
- Guselkumab
- Where
- 94 sites in United States, Canada
- Volunteers
- 211 people
- Sponsor
- Janssen Research & Development, LLC
Urinary Bladder Neoplasms
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
- Trial name
- SunRISe-4 (NCT04919512)
- Testing
- TAR-200, Cetrelimab
- Where
- 109 sites in United States, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant
The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance…
- Trial name
- AURIGA (NCT03901963)
- Testing
- Daratumumab, Lenalidomide
- Where
- 73 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Janssen Research & Development, LLC
Smoldering Multiple Myeloma
A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk…
- Trial name
- NCT03301220
- Testing
- Daratumumab SC: daratumumab + rHuPH20
- Where
- 163 sites in United States, Argentina and 22 more
- Volunteers
- 390 people
- Sponsor
- Janssen Research & Development, LLC
Extraintestinal Pathogenic Escherichia Coli Prevention
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1).
- Trial name
- NCT03819049
- Testing
- ExPEC10V, ExPEC4V, Prevnar 13
- Where
- 29 sites in United States, Belgium and 3 more
- Volunteers
- 836 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
- Trial name
- NCT03652064
- Testing
- Daratumumab, Bortezomib, Lenalidomide
- Where
- 114 sites in United States, Brazil and 11 more
- Volunteers
- 395 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- NCT03158285
- Testing
- Guselkumab
- Where
- 138 sites in United States, Bulgaria and 11 more
- Volunteers
- 741 people
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis
A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.
- Trial name
- FRONTIER 2 (NCT05364554)
- Testing
- JNJ-77242113
- Where
- 60 sites in United States, Canada and 8 more
- Volunteers
- 227 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant
The purpose of this study is to assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia…
- Trial name
- NCT04533529
- Testing
- Seltorexant
- Where
- 122 sites in United States, Brazil and 9 more
- Volunteers
- 588 people
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis
A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.
- Trial name
- SUMMIT (NCT05357755)
- Testing
- JNJ-77242113
- Where
- 34 sites in United States, Canada and 4 more
- Volunteers
- 90 people
- Sponsor
- Janssen Research & Development, LLC
Moderate Plaque Psoriasis
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
- Trial name
- SPECTREM (NCT06039189)
- Testing
- Guselkumab
- Where
- 64 sites in United States, Canada
- Volunteers
- 338 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
- Trial name
- NCT02316106
- Testing
- daratumumab
- Where
- 57 sites in United States, Australia and 9 more
- Volunteers
- 123 people
- Sponsor
- Janssen Research & Development, LLC