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Monoclonal Antibodies

Secukinumab 2 mL auto-injector for Plaque Psoriasis (MATURE Trial)

Phase 3
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 52 weeks
Awards & highlights

Summary

The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
PASI 75 Response After 12 Weeks of Treatment
Secondary outcome measures
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response
PASI 90 Response
+1 more

Side effects data

From 2020 Phase 3 trial • 122 Patients • NCT03589885
15%
Nasopharyngitis
10%
Hypertension
7%
Pruritus
7%
Upper respiratory tract infection
7%
Influenza like illness
5%
Headache
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg (2 mL Auto-Injector)
Any Secukinumab 300 mg
Secukinumab 300 mg (2 x 1 mL PFS)
Any Secukinumab 300 mg (2 mL AI)
Any Secukinumab 300 mg (2 x 1 mL PFS)
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Secukinumab 2 mL auto-injectorExperimental Treatment1 Intervention
Secukinumab 300 mg provided in 2 mL auto-injector form
Group II: Secukinumab 1 mL prefilled syringeActive Control1 Intervention
Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
Group III: Placebo 2 mL auto-injectorPlacebo Group1 Intervention
Placebo to secukinumab s.c., provided in 2 mL auto-injector form
Group IV: Placebo 1 mL prefilled syringePlacebo Group1 Intervention
Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
FDA approved

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,882 Total Patients Enrolled
~18 spots leftby Sep 2025
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