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Monoclonal Antibodies

ABP 654 for Plaque 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 baseline (day 1 [week 0]), weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized fas only), 44 (dose intensification only) and week 52 (eos)
Awards & highlights

Study Summary

This study is evaluating whether a drug called ABP 654 may be an effective treatment for plaque psoriasis.

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1 [week 0]), weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized fas only), 44 (dose intensification only) and week 52 (eos)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1 [week 0]), weeks 4, 16, 28, 36 (dose intensification only), 40 (re-randomized fas only), 44 (dose intensification only) and week 52 (eos) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PASI Percent Change From Baseline to Week 12
Secondary outcome measures
Change From Baseline in Percentage of BSA Affected With Psoriasis at Week 12 and Week 52
Number of Participants Developing Anti-drug Antibodies (ADAs) to ABP 654
Number of Participants With Events of Interests (EOIs)
+5 more

Side effects data

From 2022 Phase 3 trial • 563 Patients • NCT04607980
13%
COVID-19
5%
Upper respiratory tract infection
2%
Proteinuria
1%
Nasopharyngitis
1%
Intervertebral disc disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Post Week 28: Ustekinumab / ABP654
Post Week 28: ABP 654 Dose Intensification
Through Week 28: ABP 654
Through Week 28: Ustekinumab
Post Week 28: ABP 654 / ABP 654
Post Week 28: Ustekinumab Dose Intensification
Post Week 28: Ustekinumab / Ustekinumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Group B (Ustekinumab - ABP 654)Experimental Treatment2 Interventions
Participants will receive SC injection of ustekinumab,45 mg (baseline BW <= 100 kg) or 90 mg (baseline BW > 100 kg) at weeks 0, 4, and 16. At week 28, participants will be re-randomized to continue on ustekinumab (Treatment group B1), or to receive ABP 654 (Treatment group B2) on weeks 28 and 40. Depending on PASI score, some participants may not be re-randomized and may receive dose intensification with ustekinumab Q8W at weeks 28, 36, and 44.
Group II: Treatment Group A (ABP 654)Experimental Treatment1 Intervention
Participants will receive subcutaneous (SC) injection of ABP 654, 45 mg (baseline BW less than equal to [<=] 100 kg) or 90 mg (baseline BW greater than [>] 100 kg) at weeks 0, 4, and 16. Further from week 28 participants will receive ABP 654 (same dose) every 12 weeks (Q12W) at weeks 28 and 40 or may receive dose intensification Q8W at weeks 28, 36, and 44, depending on PASI score.
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
1,370 Previous Clinical Trials
1,377,125 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,568 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
2020. "A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04607980.
~127 spots leftby Apr 2025
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