Clinical trials: sponsored by Janssen Research & Development, LLC
Neoplasms
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968…
- Trial name
- NCT06150157
- Testing
- JNJ-88549968, Ruxolitinib, Momelotinib
- Where
- 45 sites in United States, Canada and 8 more
- Volunteers
- 300 people
- Sponsor
- Janssen Research & Development, LLC
HIV Infections
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB…
- Trial name
- ATLAS-2M (NCT03299049)
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension
- Where
- 119 sites in United States, Argentina and 11 more
- Volunteers
- 1,049 people
- Sponsor
- ViiV Healthcare
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
Metastatic Castration-resistant Prostate Cancer (mCRPC)
GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC)…
- Trial name
- NCT07871435
- Testing
- GI-102, Pasritamig
- Where
- 6 sites in United States, South Korea
- Volunteers
- 107 people
- Sponsor
- GI Innovation, Inc.
Multiple Myeloma, Refractory Multiple Myeloma
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma.
- Conditions
- Multiple Myeloma, Refractory Multiple Myeloma, Multiple Myeloma in Relapse, Relapse
- Trial name
- NCT04176718
- Testing
- Daratumumab, Carfilzomib, Pomalidomide
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- Andrew Yee, MD
Crohn Disease
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term…
- Trial name
- DUET ENCORE-CD (NCT07577843)
- Testing
- JNJ-78934804, Guselkumab
- Where
- 252 sites in United States, Argentina and 28 more
- Volunteers
- 460 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic…
- Trial name
- DUET ENCORE-UC (NCT07577856)
- Testing
- JNJ-78934804, Guselkumab
- Where
- 279 sites in United States, Argentina and 30 more
- Volunteers
- 644 people
- Sponsor
- Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma
The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells [white…
- Trial name
- NCT05757973
- Testing
- Talquetamab
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and…
- Trial name
- TRIlogy-7 (NCT07665450)
- Testing
- Ramantamig, Daratumumab, Lenalidomide
- Where
- 30 sites in France, Greece and 7 more
- Volunteers
- 1,000 people
- Sponsor
- Janssen Research & Development, LLC
Cytokine Release Syndrome, Recurrent Multiple Myeloma
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period…
- Conditions
- Cytokine Release Syndrome, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- Trial name
- NCT07657312
- Testing
- Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Naresh Bumma
Relapsed or Refractory Multiple Myeloma
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma
The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.
- Trial name
- NCT05503550
- Testing
- Talquetamab
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and…
- Trial name
- VENTURA-LT (NCT05518149)
- Testing
- Aticaprant
- Where
- 234 sites in United States, Argentina and 19 more
- Volunteers
- 871 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis, Colitis, Ulcerative
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the…
- Conditions
- Psoriasis, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic
- Trial name
- NCT07654751
- Testing
- Breast Milk Sample Collection, Guselkumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Janssen Research & Development, LLC
Hematologic Malignancy, Bone Marrow Transplant Rejection
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor…
- Conditions
- Hematologic Malignancy, Bone Marrow Transplant Rejection, Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
- Trial name
- NCT06398457
- Testing
- Darzalex Faspro (Daratumumab and hyaluronidase-fihj), JH-DSA Semi-Quant Screen and Response Score
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Venous Thromboembolism, Children Under 2 Years
A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
- Trial name
- XAPAEDUS (NCT05900388)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care (SOC)
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 850 people
- Sponsor
- Bayer
Depressive Disorder, Major
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood…
- Trial name
- NCT07573176
- Testing
- Seltorexant
- Where
- 45 sites in United States, Brazil and 4 more
- Volunteers
- 600 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
A Long-term Extension Study of PCI-32765 (Ibrutinib)
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that…
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
- Trial name
- CAN3001 (NCT01804686)
- Testing
- Ibrutinib
- Where
- 175 sites in United States, Argentina and 28 more
- Volunteers
- 539 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig…
- Trial name
- TRI Pro (NCT07589634)
- Testing
- Ramantamig, Tocilizumab
- Where
- 38 sites in United States, Argentina and 7 more
- Volunteers
- 230 people
- Sponsor
- Janssen Research & Development, LLC
Geographic Atrophy, Macular Degeneration
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.
- Trial name
- NCT06635148
- Testing
- JNJ-81201887
- Where
- 104 sites in United States, Australia and 16 more
- Volunteers
- 274 people
- Sponsor
- Janssen Research & Development, LLC
Advanced Stage Solid Tumors
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.
- Trial name
- NCT07107230
- Testing
- JNJ-95437446, Amivantamab
- Where
- 10 sites in United States, South Korea and 1 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
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