Psoriasis Clinical Trial
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab
Summary
The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab as compared with the selective inhibition of IL-23 with guselkumab (p19 subunit blocker) in controlling inflammation in psoriatic plaques that remain active despite treatment with the non-selective IL-23 inhibitor ustekinumab (blocker of p40 subunit, shared by IL-12 and IL 23).
Full Description
This was 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) is described and biopsied at baseline and at study end. The objective of the study was to assess the superiority of secukinumab over guselkumab in achieving clear/almost clear status (TCS 0-2) of the target plaques; and to describe the molecular mechanisms behind this difference
Eligibility Criteria
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
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There are 14 Locations for this study
New Orleans Louisiana, 70112, United States
East Windsor New Jersey, 08520, United States
Philadelphia Pennsylvania, 19140, United States
Dallas Texas, 75230, United States
Verdun Quebec, H4G 3, Canada
Berlin , 13353, Germany
Bochum , 44791, Germany
Bonn , 53105, Germany
Frankfurt , 60590, Germany
Halle (Saale) , 06108, Germany
Hamburg , 22391, Germany
Kiel , 24105, Germany
Memmingen , 87700, Germany
Selters , 56242, Germany
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