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



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/31/2018
Start Date:October 1, 2018
End Date:August 2, 2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A 16-week Randomized, Open-label, Multicenter Study to Assess the Superiority of Secukinumab Over Guselkumab in the Complete Treatment of Ustekinumab Resistant Psoriatic Plaques

The aim of this study is 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).

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
We found this trial at
2
sites
Houston, Texas 77030
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Houston, TX
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Charleston, South Carolina 29407
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Charleston, SC
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