Clinical trials: completed, sponsored by Janssen Research & Development, LLC
- Lead sponsor (exact) Janssen Research & Development, LLC
- Status Completed
- Funder type Industry (pharma, biotech, devices)
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
Acute Lymphoblastic Leukemia, Acute Leukemias
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Leukemias, Acute Myeloid Leukemia
- Trial name
- NCT07295951
- Testing
- 14C-bleximenib, bleximenib
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive…
- Trial name
- Moonlight-1 (NCT06785012)
- Testing
- JNJ-89495120
- Where
- 44 sites in United States
- Volunteers
- 105 people
- Sponsor
- Janssen Research & Development, LLC
Relapsing Remitting Multiple Sclerosis
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose…
- Trial name
- VISTA (NCT06083753)
- Testing
- PIPE-307 Dose A, PIPE-307 Dose B
- Where
- 21 sites in United States
- Volunteers
- 182 people
- 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
Inherited Retinal Diseases
Global Patient Registry of Inherited Retinal Diseases
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.
- Trial name
- EYERD Registry (NCT05957276)
- Testing
- Standard of Care
- Where
- 75 sites in United States, Australia and 16 more
- Volunteers
- 886 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
Carcinoma, Non-Small-Cell Lung
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and docetaxel combination therapy in participants with metastatic non-small cell lung cancer (NSCLC) in Phase 1…
- Trial name
- swalloWTail (NCT06532032)
- Testing
- Amivantamab, Docetaxel
- Where
- 15 sites in United States, Taiwan and 2 more
- Volunteers
- 12 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Juvenile
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
- Trial name
- PSUMMIT-Jr (NCT05083182)
- Testing
- Ustekinumab, Guselkumab
- Where
- 50 sites in United States, Argentina and 8 more
- Volunteers
- 48 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
Acute Coronary Syndrome
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death…
- Trial name
- LIBREXIA-ACS (NCT05754957)
- Testing
- Milvexian
- Where
- 1,003 sites in United States, Argentina and 42 more
- Volunteers
- 14,194 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)
The purpose of this study is to evaluate sleep in participants with Major Depressive Disorder with moderate to severe insomnia symptoms (MDDIS) or MDD with no or mild insomnia symptoms (non-MDDIS), using an at-home sleep…
- Trial name
- NCT07258485
- Where
- 23 sites in United States
- Volunteers
- 94 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