Fiche société
Janssen Research & Development, LLC
Traitements, essais et publications liés.
Traitements37programmes
Essais14liés
Publications7liées
SourceDBlocale
Traitements
37| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| Abiraterone acetateThe purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants. | Cancer, SEP | Phase 1 | Ralentissement de la progression | United States, Canada | À vérifier |
| Ami-HCThe purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery. | Cancer | Phase 1 | À vérifier | United States, Canada, South Korea, United Kingdom | À vérifier |
| Ami-HC-CFThe purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery. | Cancer | Phase 1 | À vérifier | United States, Canada, South Korea, United Kingdom | À vérifier |
| Ami-LCThe purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery. | Cancer | Phase 1 | À vérifier | United States, Canada, South Korea, United Kingdom | À vérifier |
| Ami-LC-MDThe purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery. | Cancer | Phase 1 | À vérifier | United States, Canada, South Korea, United Kingdom | À vérifier |
| AmivantamabThe purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations. | Cancer | Phase 3 | Ralentissement de la progression | United States, Australia, Belgium, Brazil, Canada, China, France, Germany, … | À vérifier |
| Best Supportive CareThe purpose of this study is to evaluate how well JNJ-101556143 plus Best Supportive Care (BSC) improves overall survival (the length of time a participant remains alive) compared with placebo plus BSC in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR). mAPMR is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone treatments designed to block male hormones (androgens). | Cancer | Phase 3 | À vérifier | À vérifier | |
| Best Supportive Care (BSC)The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies). | Cancer | Phase 3 | À vérifier | United States, Australia, Belgium, Brazil, Canada, China, France, Germany, … | À vérifier |
| Dextromethorphan hydrobromideThe purpose of this study is to evaluate the effects of multiple doses of abiraterone acetate plus prednisone on the pharmacokinetics (study of what the body does to a drug) of single doses of dextromethorphan hydrobromide and theophylline in patients with castration resistant prostate cancer. | SEP | Phase 1 | À vérifier | United States, Canada | À vérifier |
| EfgartigimodThe purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness). | Myasthénie | Phase 3 | United States, Germany, Israel, Spain, Switzerland | À vérifier | |
| JNJ-101556143The purpose of this study is to evaluate how well JNJ-101556143 plus Best Supportive Care (BSC) improves overall survival (the length of time a participant remains alive) compared with placebo plus BSC in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR). mAPMR is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone treatments designed to block male hormones (androgens). | Cancer | Phase 3 | À vérifier | À vérifier | |
| JNJ-101556143 Formulation 1Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations. | Cancer | Phase 1/2 | À vérifier | United States, United Kingdom | À vérifier |
| JNJ-101556143 Formulation 2Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations. | Cancer | Phase 1/2 | À vérifier | United States, United Kingdom | À vérifier |
| JNJ-101556143 Formulation 3Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations. | Cancer | Phase 1/2 | À vérifier | United States, United Kingdom | À vérifier |
| JNJ-63733657The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function. | Alzheimer | Phase 2 | À vérifier | United States, Australia, Belgium, Canada, France, Japan, Netherlands, Spain, … | À vérifier |
| JNJ-87189401The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies). | Cancer | Phase 3 | À vérifier | United States, Australia, Belgium, Brazil, Canada, China, France, Germany, … | À vérifier |
| Mitomycin CThis study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder. | Cancer | Phase 3 | Traitement symptomatique | United States, Argentina, Belgium, Brazil, China, France, Germany, Italy, … | À vérifier |
| NipocalimabThe purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs). | Lupus, Myasthénie | Phase 3 | United States, Germany, Israel, Spain, Switzerland | À vérifier | |
| Nipocalimab SC-LIVThe purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG. | Myasthénie | Phase 3 | À vérifier | United States, Australia, Belgium, Canada, China, Czechia, Denmark, France, … | À vérifier |
| PasritamigThe purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies). | Cancer | Phase 3 | À vérifier | United States, Australia, Belgium, Brazil, Canada, China, France, Germany, … | À vérifier |
| PIPE-307 Dose AThis 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 A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks. | SEP | Phase 2 | À vérifier | United States | À vérifier |
| PIPE-307 Dose BThis 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 A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks. | SEP | Phase 2 | À vérifier | United States | À vérifier |
| TAR-200The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy. | Cancer | Phase 3 | Traitement symptomatique | United States, Argentina, Belgium, Brazil, China, France, Germany, Italy, … | À vérifier |
| PIPE-307 Dose AThis 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 A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks. | SEP | Phase 2 | À vérifier | United States | À vérifier |
| NipocalimabThe purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs). | Lupus | Phase 3 | United States, Argentina, Australia, Brazil, Bulgaria, China, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Norway, … | À vérifier | |
| NipocalimabThe purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs). | Myasthénie | Phase 3 | United States, Germany, Israel, Spain, Switzerland | À vérifier | |
| NipocalimabThe purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs). | Myasthénie | Phase 2/3 | United States, Japan, Netherlands, Poland | À vérifier | |
| NipocalimabThe purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs). | Myasthénie | Phase 3 | United States, Australia, Belgium, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Poland, South Korea, Spain, Sweden, Taiwan | À vérifier | |
| AmivantamabThe purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations. | Cancer | Phase 3 | Ralentissement de la progression | United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Russia, South Korea, … | À vérifier |
| JNJ-101556143 Formulation 1Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations. | Cancer | Phase 1/2 | À vérifier | United States, United Kingdom | À vérifier |
| EfgartigimodThe purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness). | Myasthénie | Phase 4 | France | À vérifier | |
| Ami-LC-MDThe purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery. | Cancer | Phase 1 | À vérifier | United States, Canada, South Korea, United Kingdom | À vérifier |
| PasritamigThe purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies). | Cancer | Phase 3 | À vérifier | United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Italy, Japan, Netherlands, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom | À vérifier |
| TAR-200The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy. | Cancer | Phase 3 | Traitement symptomatique | United States, Argentina, Belgium, Brazil, China, France, Germany, Italy, Japan, Poland, Romania, South Korea, Spain, United Kingdom | À vérifier |
| Abiraterone acetateThe purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants. | SEP | Phase 1 | Ralentissement de la progression | United States, Canada | À vérifier |
| JNJ-101556143The purpose of this study is to evaluate how well JNJ-101556143 plus Best Supportive Care (BSC) improves overall survival (the length of time a participant remains alive) compared with placebo plus BSC in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR). mAPMR is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone treatments designed to block male hormones (androgens). | Cancer | Phase 3 | À vérifier | À vérifier | |
| JNJ-63733657The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function. | Alzheimer | Phase 2 | À vérifier | United States, Australia, Belgium, Canada, France, Japan, Netherlands, Spain, Sweden, United Kingdom | À vérifier |
Essais cliniques
14| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| JNJ-63733657 | Alzheimer | Phase 2 | NCT04619420 | Autonomy — A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease | TERMINATED |
| JNJ-101556143 | Cancer | Phase 3 | NCT07906717 | A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer | NOT_YET_RECRUITING |
| Abiraterone acetate | SEP | Phase 1 | NCT01017939 | A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer | COMPLETED |
| TAR-200 | Cancer | Phase 3 | NCT06211764 | SunRISe-5 — A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) | ACTIVE_NOT_RECRUITING |
| Pasritamig | Cancer | Phase 3 | NCT07164443 | KLK2-comPAS — A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) | RECRUITING |
| Ami-LC-MD | Cancer | Phase 1 | NCT04606381 | PALOMA — A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies | ACTIVE_NOT_RECRUITING |
| Efgartigimod | Myasthénie | Phase 4 | NCT07072988 | OPTIMAGE — Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod | RECRUITING |
| JNJ-101556143 Formulation 1 | Cancer | Phase 1/2 | NCT06800313 | Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer | RECRUITING |
| Amivantamab | Cancer | Phase 3 | NCT04538664 | PAPILLON — A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions | ACTIVE_NOT_RECRUITING |
| Nipocalimab | Myasthénie | Phase 3 | NCT04951622 | A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | RECRUITING |
| Nipocalimab | Myasthénie | Phase 2/3 | NCT05265273 | A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis | RECRUITING |
| Nipocalimab | Myasthénie | Phase 3 | NCT07217587 | EPIC — Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis | RECRUITING |
| Nipocalimab | Lupus | Phase 3 | NCT07438496 | GARDENIA-SLE — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus | RECRUITING |
| PIPE-307 Dose A | SEP | Phase 2 | NCT06083753 | VISTA — Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis | COMPLETED |
Publications
7| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Nipocalimab | Nipocalimab and other FcRn blockers in neuromuscular disorders. | Pharmacology & therapeutics | ||
| Nipocalimab | Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials. | Human vaccines & immunotherapeutics | ||
| Nipocalimab | Hospital resource utilization in patients with generalized myasthenia gravis treated with nipocalimab: results from the VIVACITY-MG3 study. | Journal of medical economics | ||
| Abiraterone acetate | Metabolic Dysfunction After Initiation of Androgen Receptor Pathway Inhibitors in Prostate Cancer. | JAMA oncology | ||
| Abiraterone acetate | Immune Spatial Organization Predicts Distant Metastasis Risk in Aggressive Localized Prostate Cancer. | Clinical cancer research : an official journal of the American Association for Cancer Research | ||
| Abiraterone acetate | Targeting the PI3K/AKT pathway in prostate cancer: the role of PTEN deficiency and biomarker-guided therapy. | Cancer biology & therapy | ||
| Nipocalimab | Pediatric Extrapolation in Neuropsychiatric Drug Development: Leveraging Pharmacokinetic and Pharmacodynamic Strategies to Facilitate FDA Approvals. | Clinical pharmacology and therapeutics |