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).

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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

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT03553823

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 14 Locations for this study

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Novartis Investigative Site
New Orleans Louisiana, 70112, United States
Novartis Investigative Site
East Windsor New Jersey, 08520, United States
Novartis Investigative Site
Philadelphia Pennsylvania, 19140, United States
Novartis Investigative Site
Dallas Texas, 75230, United States
Novartis Investigative Site
Verdun Quebec, H4G 3, Canada
Novartis Investigative Site
Berlin , 13353, Germany
Novartis Investigative Site
Bochum , 44791, Germany
Novartis Investigative Site
Bonn , 53105, Germany
Novartis Investigative Site
Frankfurt , 60590, Germany
Novartis Investigative Site
Halle (Saale) , 06108, Germany
Novartis Investigative Site
Hamburg , 22391, Germany
Novartis Investigative Site
Kiel , 24105, Germany
Novartis Investigative Site
Memmingen , 87700, Germany
Novartis Investigative Site
Selters , 56242, Germany

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT03553823

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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