ustekinumab
ustekinumab: sourced relationships with 1 company · 14 clinical trials tracked · 2 FDA decisions.
ustekinumab evidence translation
What we can confirm
2 FDA records · 14 tracked trials
What it means
What to watch
Prepared research question
How could ustekinumab → AMGN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 2 study sponsors
Related indications
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| AMGEN INC (AMGN) Reported 2023-10-31 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (14)showing 10 most recent
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis
Primary endpoint: Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
77242113PSO3006: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ 77242113 for the Treatment of Participants With Moderate to Severe Plaque Ps
Primary endpoint: JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Primary endpoint: Psoriasis Area Severity Index 90 (PASI90) response at Week 16
An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)
Primary endpoint: Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26
VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study
Primary endpoint: To assess time of onset of biologic therapy in pain interference
A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)
Primary endpoint: Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups
A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)
Primary endpoint: Number of Participants With Adverse Events (AEs)
An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
Primary endpoint: Incidence Rate for Malignancy
A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Primary endpoint: Global Outcome Measure: Percentage of Participants With Clinical Remission at Induction Week 8 (Week I-8)
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Primary endpoint: Percentage of Participants Achieving Clinical Remission at Week 24
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with ustekinumab?
ustekinumab has dated SEC/FDA relationship records for AMGEN INC.
How many clinical trials involve ustekinumab?
BioSniper tracks 14 clinical trials involving ustekinumab.
What is ustekinumab's latest FDA decision?
The most recent tracked FDA decision for ustekinumab is Approval for 1 INDICATIONS AND USAGE WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult patients. ( 1.3 ) Moderately to severely active ulcerative colitis in adult patients . ( 1.4 ) 1.1 Plaque Psoriasis (PsO) WEZLANA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) WEZLANA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn's Disease (CD) WEZLANA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis (UC) WEZLANA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis., dated October 31, 2023.