Clinical trials: 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
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
- Trial name
- PROTOSTAR (NCT03451851)
- Testing
- Guselkumab, Etanercept
- Where
- 39 sites in United States, Australia and 7 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
- Trial name
- ICONIC-LEAD (NCT06095115)
- Testing
- JNJ-77242113
- Where
- 170 sites in United States, Argentina and 14 more
- Volunteers
- 684 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Colitis, Ulcerative
A Long-term Extension Study of Ustekinumab in Pediatric Participants
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
- Conditions
- Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic
- Trial name
- UNITED (NCT05092269)
- Testing
- Ustekinumab
- Where
- 48 sites in United States, Argentina and 11 more
- Volunteers
- 159 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Crohns Disease, Colitis, Ulcerative
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile…
- Conditions
- Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile
- Trial name
- TRILOGY (NCT06663332)
- Testing
- Guselkumab
- Where
- 51 sites in United States, Argentina and 15 more
- Volunteers
- 196 people
- Sponsor
- Janssen Research & Development, LLC
Leukemia, Myeloid, Acute
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in…
- Trial name
- NCT05453903
- Testing
- Bleximenib, Venetoclax (VEN), Azacitidine (AZA)
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 196 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study of Daratumumab
The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies…
- Trial name
- NCT05438043
- Testing
- Daratumumab, Carfilzomib, Dexamethasone
- Where
- 92 sites in United States, Belgium and 15 more
- Volunteers
- 213 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC…
- Trial name
- ICONIC-UC (NCT07196748)
- Testing
- Icotrokinra
- Where
- 402 sites in United States, Argentina and 26 more
- Volunteers
- 882 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical…
- Trial name
- MACARONI-23 (NCT05923073)
- Testing
- Guselkumab
- Where
- 85 sites in United States, Australia and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
- Trial name
- ICONIC-ASCEND (NCT06934226)
- Testing
- JNJ-77242113, Ustekinumab
- Where
- 160 sites in United States, Argentina and 11 more
- Volunteers
- 752 people
- Sponsor
- Janssen Research & Development, LLC
Acute Leukemia
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion).
- Trial name
- cAMeLot-1 (NCT04811560)
- Testing
- Bleximenib
- Where
- 102 sites in United States, Australia and 11 more
- Volunteers
- 420 people
- Sponsor
- Janssen Research & Development, LLC
Plaque Psoriasis
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).
- Trial name
- ICONIC-TOTAL (NCT06095102)
- Testing
- JNJ-77242113
- Where
- 90 sites in United States, Argentina and 9 more
- Volunteers
- 311 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder…
- Trial name
- AVENUE (NCT07227454)
- Testing
- Esketamine, Midazolam
- Where
- 44 sites in United States, Brazil and 5 more
- Volunteers
- 258 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
Tuberculosis, Multidrug-Resistant
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less…
- Trial name
- NCT02354014
- Testing
- Bedaquiline (TMC207), Background Regimen (BR)
- Where
- 11 sites in Mozambique, Philippines and 4 more
- Volunteers
- 60 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, 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
Myasthenia Gravis
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age (globally) and 8 to <18 years of age (for Unites Stated (US)…
- Trial name
- NCT05265273
- Testing
- Nipocalimab
- Where
- 19 sites in United States, Japan and 2 more
- Volunteers
- 12 people
- Sponsor
- Janssen Research & Development, LLC