Clinical trials: sponsored by Janssen Research & Development, LLC
Depressive Disorder, Major
54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide
The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder…
- Trial name
- Aspire II (NCT03097133)
- Testing
- Esketamine, Standard of Care
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 230 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing…
- Trial name
- NCT03185819
- Testing
- Midazolam, Esketamine
- Where
- 51 sites in United States, Belgium and 7 more
- Volunteers
- 147 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an…
- Trial name
- NCT03227224
- Testing
- JNJ-42847922
- Where
- 101 sites in United States, Bulgaria and 6 more
- Volunteers
- 287 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara…
- Trial name
- NCT03277105
- Testing
- Dara SC, Dara IV
- Where
- 146 sites in United States, Australia and 16 more
- Volunteers
- 522 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram [mg] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an…
- Trial name
- NCT03321526
- Testing
- JNJ-42847922, Quetiapine XR, Selective Serotonin Reuptake Inhibitor (SSRI)
- Where
- 50 sites in United States
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Schizophrenia
A Study of Paliperidone Palmitate 6-Month Formulation
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone…
- Trial name
- NCT03345342
- Testing
- PP6M, PP3M 350 mg eq., PP3M 525 mg eq.
- Where
- 138 sites in United States, Argentina and 19 more
- Volunteers
- 841 people
- Sponsor
- Janssen Research & Development, LLC
Insomnia Disorders
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document…
- Trial name
- NCT03375203
- Testing
- JNJ-42847922, 5 mg, JNJ-42847922, 10 mg, JNJ-42847922, 20 mg
- Where
- 56 sites in United States, Belgium and 4 more
- Volunteers
- 365 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate…
- Trial name
- NCT03412565
- Testing
- Daratumumab, Bortezomib, Lenalidomide
- Where
- 64 sites in United States, Brazil and 7 more
- Volunteers
- 265 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal…
- Trial name
- NCT03434041
- Testing
- Esketamine 56 mg, Esketamine 84 mg, Duloxetine (Oral Antidepressant)
- Where
- 30 sites in United States, China
- Volunteers
- 252 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
- Trial name
- NCT03517722
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 mg
- Where
- 204 sites in United States, Argentina and 18 more
- Volunteers
- 516 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin…
- Trial name
- NCT03559192
- Testing
- JNJ-67953964
- Where
- 53 sites in United States, Germany and 4 more
- Volunteers
- 181 people
- Sponsor
- Janssen Research & Development, LLC
Schizophrenia
A Study of Paliperidone Palmitate 6-Month Formulation
The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the…
- Trial name
- NCT04072575
- Testing
- PP6M injection Dose 1, PP6M injection Dose 2
- Where
- 30 sites in Argentina, Hong Kong and 4 more
- Volunteers
- 178 people
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of Lazertinib when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+)…
- Trial name
- NCT04075396
- Testing
- Lazertinib
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder With Anxious Distress
A Study of JNJ-61393215 in the Treatment of Depression
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale…
- Trial name
- NCT04080752
- Testing
- JNJ-61393215
- Where
- 35 sites in United States, Moldova and 3 more
- Volunteers
- 222 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.
- Trial name
- PROGRESS (NCT05784129)
- Testing
- Guselkumab
- Where
- 11 sites in United States, Poland
- Volunteers
- 4 people
- Sponsor
- Janssen Research & Development, LLC
Alzheimer Disease
A Study of Seltorexant in Participants With Probable Alzheimer's Disease
The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with…
- Trial name
- NCT05307692
- Testing
- Seltorexant
- Where
- 25 sites in United States
- Volunteers
- 88 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
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with…
- Trial name
- NCT04599855
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 54 sites in United States
- Volunteers
- 477 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B, Chronic
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
- Trial name
- OCTOPUS-1 (NCT05275023)
- Testing
- JNJ-73763989, PD-1 inhibitor, Tenofovir Disoproxil
- Where
- 26 sites in Canada, Czechia and 6 more
- Volunteers
- 37 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