Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW)
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW)
ClinicalTrials.gov ID: NCT03553823
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis (Novartis Pharmaceuticals) (Responsible Party)
Last Update Posted: 2021-10-11
Brief 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).
Detailed 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
Intervention / Treatment:
- Procedure: Skin biopsies
| Category | Value |
|---|---|
| Study Start (Actual) | 2019-01-14 |
| Primary Completion (Estimated) | 2020-01-28 |
| Study Completion (Estimated) | 2020-01-28 |
| Enrollment (Estimated) | 40 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
CAIN457A2403
2018-001048-70 (EudraCT Number) |