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Monoclonal Antibodies
secukinumab for Plaque Psoriasis (ARROW Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 week
Awards & highlights
No Placebo-Only Group
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).
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2)
Side effects data
From 2020 Phase 2 trial • 40 Patients • NCT0355382310%
Gout
10%
Nasopharyngitis
5%
Acute kidney injury
5%
Asthma
5%
Gastritis
5%
Pneumonia
5%
Sepsis
5%
Blood bilirubin increased
5%
Dacryostenosis acquired
5%
Erysipelas
5%
Herpes zoster
5%
Hyperglycaemia
5%
Postoperative wound infection
5%
Vulvovaginal mycotic infection
5%
Wound dehiscence
5%
Balanoposthitis
5%
Miliaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab
Guselkumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: secukinumabExperimental Treatment1 Intervention
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
Group II: GuselkumabActive Control1 Intervention
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skin biopsies
2012
Completed Phase 2
~590
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,913 Previous Clinical Trials
4,253,123 Total Patients Enrolled
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