Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab

This is a 16-week, randomized, open-label, parallel-group, active-control, Phase 2a study
comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque
psoriasis who had an inadequate response to ustekinumab. Forty subjects will be randomized
1:1 and treated for 16 weeks. In each patient, a target active refractory skin plaque (TCS
≥6) will be described and biopsied at baseline and at study end. The objective of the study
is to assess the superiority of secukinumab over guselkumab in achieving clear/almost clear
status (TCS 0-2) of the target plaques and describe the molecular mechanisms behind this
difference

Inclusion Criteria:

Chronic plaque-type psoriasis considered inadequately controlled after treatment with
ustekinumab according to the following criteria-:

- Ustekinumab administered at a dose equal or higher than that on the label for at least
24 weeks. The last administration must be at least 12 weeks before randomization

- absolute PASI score of 1-10 at Screening

- Presence of at least 1 refractory skin plaque, defined by a TCS of at least 6 and
severity score of at least 2 or 3 (moderate) for each individual item, with an area ≥
10 cm2 at screening.

Exclusion Criteria:

- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
guttate psoriasis) at Screening or Baseline

- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers,
calcium channel inhibitors or lithium) at Baseline

- Previous treatment with more than one TNFα inhibitor or with IL-17A (including
secukinumab), IL-17R or IL-23 (including guselkumab) inhibitors

- Use of other investigational drugs within 4 weeks before enrolment, or within a period
of 5 half lives of enrollment/initiation of the study treatment, whichever is longer

- Ongoing use of prohibited treatments (see Section 6.2.2)

- Known immunosuppression (e.g., AIDS) at Screening