Study of efficacy and safety of secukinumab 2 mL pre-filled syringe (300 mg) in subjects with moderate to severe plaque psoriasis

A multicenter, randomized, double-blind, placebo-controlled, 52-weeks study to demonstrate the efficacy, safety and tolerability of subcutaneous secukinumAb injections with 2 mL pre-fiLLed syringes (300 mg) in adUlt subjects with moderate to seveRE plaque psoriasis – ALLURE - ALLURE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005170-38-GB

Enrollment

210

Registered

2016-07-22

Start date

2016-09-30

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque psoriasis MedDRA version: 19.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

Interventions

Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Men or women of at least 18 years of age at the time of Screening. * Moderate to severe chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. * Candidate for systemic therapy. * Additional inclusion criteria may apply , please refer to the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 189 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

Exclusion criteria: * Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) * Ongoing use of prohibited treatments. * Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. * Pregnant or nursing (lactating) women *Additional exclusion criteria may apply , please refer to the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo.; Secondary Objective: • To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 90 and PASI 100 at Week 12, compared to placebo. • To demonstrate the efficacy of secukinumab 300 mg when administered as two 1 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 100 at Week 12, compared to placebo. ;Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo.; Secondary Objective: • To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 90 and PASI 100 at Week 12, compared to placebo. • To demonstrate the efficacy of secukinumab 300 mg when administered as two 1 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 100 at Week 12, compared to placebo. ;Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response;Timepoint(s) of evaluation of this end point: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): PASI 90 and PASI 100;Timepoint(s) of evaluation of this end point: Week 12	—

Countries

Belgium, Canada, Germany, Iceland, Latvia, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactMedica Information Services

Novartis Pharmaceuticals UK Limited

medinfo.uk@novartis.com+44 1276 698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026