Wirksamkeits- und Sicherheitsvergleich von Brodalumab versus Guselkumab bei erwachsenen Patienten mit mittelschwerer bis schwerer Plaque-Psoriasis und unzureichender Reaktion auf Ustekinumab.

Biological: Brodalumab;Other: Placebo;Biological: Guselkumab

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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.