A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: ABP 654; Ustekinumab
Intervention description: Participants will receive SC injection of ABP 654.; Participants will receive SC injection of ustekinumab.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The Investigators, study personnel with the exception of the clinical research organization's unblinded biostatistician and unblinded programmers; and the data monitoring committee, and the study participants will remain blinded to treatment allocation.
Enrollment: 563.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Psoriasis; Biosimilar; Psoriasis area and severity index

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants are eligible to be included in the study only if all of the following criteria
        apply:

          -  Stable moderate to severe plaque psoriasis for at least 6 months

          -  Baseline score of PASI >= 12, involvement of >= 10% BSA, and sPGA >= 3 at screening
             and at baseline

          -  Candidate for phototherapy or systemic therapy

          -  Previous failure, inadequate response, intolerance, or contraindication to at least 1
             conventional anti-psoriatic systemic therapy

          -  Female participants should have negative serum pregnancy test during screening and a
             negative urine pregnancy test at baseline

          -  No known history of latent or active tuberculosis (TB), and has a negative test for TB
             during screening (with negative purified protein derivative (PPD), and Negative
             Quantiferon®/T-spot test)

          -  Participants with a positive purified protein derivative and a history of Bacillus
             Calmette-Guérin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®

          -  Participants with a positive PPD test (without history of BCG vaccination) or
             participants with a positive or indeterminate Quantiferon®/T-spot test are allowed if
             they have all of the following:

               -  No symptoms per TB worksheet provided by the sponsor

               -  Documented history of adequate prophylaxis initiation prior to receiving
                  investigational product (IP) in accordance with local recommendations

               -  No known exposure to a case of active TB after most recent prophylaxis

               -  No evidence of active TB on chest radiograph within 3 months prior to the first
                  dose of IP

        Exclusion Criteria:

        Participants are excluded from the study if any of the following criteria apply:

          -  Skin disease related conditions such as, Erythrodermic psoriasis (PsO), pustular PsO,
             guttate PsO, medication induced PsO, or other skin conditions at the time of the
             screening visit (eg, eczema) that would interfere with evaluations of the effect of IP
             on PsO

          -  Participant has an active infection, recurrent or chronic infections, serious
             infection or history of infections

          -  Known history of human immunodeficiency virus

          -  Hepatitis B surface antigen or hepatitis C virus antibody positivity at screening

          -  Uncontrolled, clinically significant systemic disease such as uncontrolled diabetes
             mellitus, cardiovascular disease, renal disease, liver disease, or hypertension

          -  Moderate to severe heart failure (New York Heart Associate class III/IV)

          -  Known hypersensitivity to the IP or to any of the excipients

          -  Any abnormal laboratory parameters at screening, as defined in protocol

          -  Previous treatment with any agent specifically targeting interleukin (IL)-12 or IL-23

          -  Received biologic treatment for psoriasis within the previous month or 5 drug
             half-lives prior to randomization

          -  Received non-biologic systemic psoriasis therapy within 4 weeks prior to randomization

          -  Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimer laser
             within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapy within 2
             weeks prior to randomization

          -  Received topical psoriasis treatment within 2 weeks prior to randomization (exception:
             upper mid-strength to least potent [class III to VII] topical steroids permitted on
             the palms, soles, face, and intertriginous areas; bland emollients)

          -  Received live viral or live bacterial vaccination within 2 weeks prior to
             randomization

          -  Received BCG vaccination within 1 year prior to randomization

          -  Other investigational procedures within 4 weeks prior to randomization and during the
             study

          -  Participants not agreeing to follow protocol defined contraceptives procedures

          -  Participants likely not to be available to complete all protocol-required study visits
             or procedures, and/or to comply with all required study procedures