Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
Condition: Plaque Psoriasis; Psoriasis Vulgaris; Psoriasis
MeSH terms: Psoriasis
Intervention: Brodalumab; Placebo; Guselkumab
Intervention description: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection; The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance; Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection
Intervention MeSH terms: Brodalumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Brodalumab (1.5 mL) and guselkumab (1.0 mL) are in pre-filled syringes and packaged open-label. Dummy injections are used for blinding.
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment
      for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms
      after ustekinumab treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant has a diagnosis of plaque psoriasis for at least 6 months before the first
             administration of investigational medicinal product (IMP) as determined by the
             investigator.

          -  Participant has inadequately controlled plaque psoriasis currently treated with
             ustekinumab, and fulfils ALL of the following criteria:

               1. Ustekinumab administered at least 3 times at or higher than the approved dose or
                  frequency before randomisation.

               2. IGA ≥2 at screening and baseline.

               3. Absolute PASI >3 at screening and baseline.

          -  Participant has no evidence of active tuberculosis according to local standard of care
             for patients requiring initiation of a biologic treatment. Participants with
             adequately treated latent tuberculosis, according to local guidelines, are eligible.

        Key Exclusion Criteria:

          -  Participant was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate
             psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that
             would interfere with evaluations of the effect of IMP on plaque psoriasis.

          -  Participant has clinically important active infections or infestations, chronic,
             recurrent, or latent infections or infestations, or is immunocompromised (e.g. human
             immunodeficiency virus).

          -  Participant has any systemic disease (e.g. renal failure, heart failure, hypertension,
             liver disease, diabetes, anaemia) considered by the investigator to be clinically
             significant and uncontrolled.

          -  Participant has a known history of Crohn's disease.

          -  Participant has any active malignancy, including evidence of cutaneous basal or
             squamous cell carcinoma or melanoma.

          -  Participant has a history of malignancy within 5 years, except for treated and
             considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer,
             or in situ breast ductal carcinoma.

          -  Participant has a known history of active tuberculosis.

          -  Participant has a history of suicidal behaviour (i.e. 'actual suicide attempt',
             'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on
             the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or
             baseline.

          -  Participant has any suicidal ideation of severity 4 or 5 ('some intent to act, no
             plan' or 'specific plan and intent') based on the C-SSRS questionnaire at screening or
             baseline.

          -  Participant has a Patient Health Questionnaire-8 (PHQ-8) score of ≥10, corresponding
             to moderate to severe depression at screening or baseline.

          -  Participant has previously been treated with any anti-interleukin (IL)-17A, anti-IL 17
             receptor subunit A, or anti-IL-23 besides ustekinumab.

          -  Participant has known or suspected hypersensitivity to any component(s) of the IMPs.