A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ABP 654 — DRUG
  Participants will receive SC injection of ABP 654.
• Ustekinumab — DRUG
  Participants will receive SC injection of ustekinumab.

Study Details

The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654 compared with ustekinumab in participants with moderate to severe plaque psoriasis.

Key Dates

Start date

Nov 11, 2020

Status verified

Dec 2024

Primary completion

Jan 13, 2022

Completion

Jun 3, 2022

Study Design

Enrollment

563 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group A (ABP 654)
  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.
• Experimental: Treatment Group B (Ustekinumab - ABP 654)
  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.

Primary Outcome Measure

PASI Percent Change From Baseline to Week 12 [ Time Frame: Baseline (Day 1 [Week 0]) and Week 12 ]

Locations (34)

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