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

Completed · Phase 2

Conditions studied: Chronic Plaque-type Psoriasis

In brief

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).

Key facts

Study ID

NCT03553823

Run by

Novartis Pharmaceuticals

People needed

40

Starts

2019-01-14

Expected to finish

2020-01-28

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — East Windsor, New Jersey, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Verdun, Quebec, Canada
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Bonn, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Halle, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — Memmingen, Germany
• Novartis Investigative Site — Selters, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.