A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab; ABP 654
Intervention description: Participants will receive subcutaneous (SC) injection of ustekinumab.; Participants will receive SC injection of ABP 654.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The investigators, study personnel (with the exception of the Data Monitoring Committee (DMC), and unblinded Parexel staff supporting DMC activities and randomization list activities) and the study participants will remain blinded to treatment allocation. ABP 654 and ustekinumab will be coded and labeled in a manner that protects blinding.
Enrollment: 494.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Psoriasis; Biosimilar; Psoriasis area and severity index; Ustekinumab; Skin Diseases; Dermatologic Agents; Papulosquamous

Summary:

      The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and
      immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued
      use of ustekinumab in participants with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has stable moderate to severe plaque psoriasis for at least 6 months

          -  Participant has a score of PASI ≥ 12, involvement of ≥ 10% body surface area and
             static Physician Global Assessment ≥ 3 at screening and at baseline

          -  Participant is a candidate for phototherapy or systemic therapy

          -  Participant has previous failure, inadequate response, intolerance, or
             contraindication to at least 1 conventional antipsoriatic systemic therapy

          -  Female participant should have a negative serum pregnancy test during screening and a
             negative urine pregnancy test at baseline

          -  Participant or legally acceptable representative is capable of giving signed
             Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent

          -  Participant has no known history of latent or active tuberculosis

          -  Participant with a positive purified protein derivative (PPD) test and a history of
             Bacillus Calmette-Guérin (BCG) vaccination is allowed with a negative
             Quantiferon/T-spot test

          -  Participant with a positive PPD test or participant with a positive or indeterminate
             Quantiferon/T-spot test is allowed if he/she has all the following:

               -  No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.

               -  Documented history of adequate prophylaxis initiation prior to receiving
                  investigational product in accordance with local recommendations

               -  No known exposure to a case of active tuberculosis after most recent prophylaxis

               -  No evidence of active tuberculosis on chest radiograph within 3 months prior to
                  the first dose of investigational product

        Exclusion Criteria:

          -  Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication induced psoriasis, or other skin conditions at the time of screening (eg,
             eczema) that would interfere with evaluations of the effect of investigational product
             of psoriasis

          -  Participant has an active infection or history of infections

          -  Participant has uncontrolled, clinically significant systemic disease, such as
             uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease,
             or hypertension

          -  Participant has a mean QT internal or abnormal long QT syndrome corrected using
             Fridericia's formula (QTcF) of > 450 msec (for male participant) or > 470 msec (for
             female participant) at baseline that, in the opinion of the Investigator, is abnormal
             or clinically significant

          -  Participant has moderate to severe heart failure (New York Heart Associate class
             III/IV)

          -  Participant has known hypersensitivity to the investigational product or to any of the
             excipients

          -  Participant has laboratory abnormalities at screening

          -  Participant has had previous treatment with any agent specifically targeting
             interleukin (IL)-12 or IL-23 within 1 year prior to enrollment

          -  Participant has received biologic treatment for psoriasis within the previous month or
             5 drug half-lives (whichever is longer) prior to enrollment

          -  Participant has received any investigational agents within the previous month or 5
             half-lives (whichever is longer) prior to enrollment

          -  Participant has received non-biologic systemic psoriasis therapy within 4 weeks prior
             to enrollment

          -  Participant has received ultraviolet A phototherapy (with or without psoralen) or
             excimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within
             2 weeks prior to enrollment

          -  Participant has received topical psoriasis treatment within 2 weeks prior to
             enrollment

          -  Participant has received other investigational procedures within 4 weeks prior to
             enrollment and during the course of the study

          -  Female participant is pregnant or breastfeeding or planning to become pregnant while
             participating in the study and for at least 5 months after the last dose of
             investigational product

          -  Sexually active participants and their partners who are of childbearing potential and
             not agreeing to use adequate protocol defined contraception methods while
             participating in the study and for 5 months after the last dose of investigational
             product