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Monoclonal Antibodies

Ustekinumab for Psoriasis

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
Awards & highlights

Summary

This trial will compare the effects of switching between two similar drugs versus continuing use of one drug in people with moderate to severe plaque psoriasis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples were taken pre-dose week 52; and at 2 days, 7 days, 10 days, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the week 52 dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (AUCtau) Between Week 52 and Week 64
Maximum Observed Serum Concentration (Cmax) Between Week 52 and Week 64
Secondary outcome measures
Number of Participants With Antidrug Antibodies (ADAs): Post-randomization Period
Number of Participants With Events of Interest (EOI): Post-randomization Period
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Post-randomization Period
+5 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Fracture
9%
Skin and subcutaneous tissue disorders
9%
Anxiety
9%
Dizziness
9%
Back pain
9%
Urinary tract infection
5%
Toothache
5%
Hypertension
5%
Pain/Pain in extremity
5%
Rash/Rash Acneiform/Maculo-Papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Switching Group (Ustekinumab - ABP 654)Experimental Treatment2 Interventions
Participants will initially receive injection of ustekinumab up to Week 16. Thereafter, starting from Week 28, participants will switch between ABP 654 and ustekinumab every 12 weeks up to Week 52.
Group II: Continued-use Group (Ustekinumab)Active Control1 Intervention
Participants will receive subcutaneous injection of ustekinumab up to Week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP 654
2021
Completed Phase 3
~1060
Ustekinumab
2013
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,626 Total Patients Enrolled
76 Trials studying Psoriasis
116,016 Patients Enrolled for Psoriasis
MDStudy DirectorAmgen
937 Previous Clinical Trials
926,773 Total Patients Enrolled
64 Trials studying Psoriasis
22,826 Patients Enrolled for Psoriasis
~112 spots leftby Sep 2025
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