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

Chronic Plaque-type Psoriasis Clinical Trial

— ARROW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553823
• Other study ID #: CAIN457A2403
• Secondary ID: 2018-001048-70
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2019
• Est. completion date: January 28, 2020

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 TNFa 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

Related Conditions & MeSH terms

• Chronic Plaque-type Psoriasis
• Psoriasis

Intervention

Procedure:
• Skin biopsies
At Baseline, two 6-mm punch biopsies were taken, one from the identified active plaque (TCS = 6) and one from never-lesional skin. At the End-of-study Visit, one biopsy was taken from the same area of the active plaque sampled at Baseline.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Verdun	Quebec
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Memmingen
Germany	Novartis Investigative Site	Selters
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	East Windsor	New Jersey
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2)	Total clinical score: number (%) of subjects who responded at Week 16 (FAS)	16 week

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com