Study of efficacy and safety of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis

A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab, to demonstrate efficacy after twelve weeks of treatment and to assess safety, tolerability and long-term efficacy up to one year in subjects with moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis comorbidity

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000524-25-HU

Enrollment

536

Registered

2016-11-30

Start date

2017-02-01

Completion date

Unknown

Last updated

2018-12-10

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

Conditions

Plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000018190

Interventions

Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Men or women at least 18 years of age at time of screening. * Moderate to severe plaque psoriasis Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline. * 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 482 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54

Exclusion criteria

Exclusion criteria: * Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, drug induced) * 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 * Women of child-bearing potential not willing to use contraception *Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab therapy *Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. Additional exclusion criteria may apply , please refer to the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis in terms of both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12 compared to placebo.;Secondary Objective: •?To demonstrate the superiority of secukinumab in terms of PASI 90 response at Week 12 compared to placebo. •?To assess the efficacy of secukinumab in maintaining PASI 75 response at Week 52 in subjects who were PASI 75 responders at Week 12 or IGA mod 2011 0 or 1 response at Week 52 in subjects who were IGA mod 2011 0 or 1 responders at Week 12. •?To assess the efficacy of secukinumab in terms of PASI score, IGA mod 2011 score, PASI 50/75/90/100 and IGA mod 2011 0 or 1 response over time up to Week 12 compared to placebo and over time up to Week 52 •?To assess the efficacy of secukinumab in terms of time to PASI 75 response up to Week 12 compared to placebo. •?To investigate the clinical safety and tolerability of secukinumab compared to placebo. •?To assess the efficacy of secukinumab in treating psoriatic arthritis in subjects with this comorbidity at Baseline in terms of American College of Rheumatology (ACR) 20/50/70 response over time up to Week 52. ;Primary end point(s): PASI 75 response 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 superiority of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis in terms of both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12 compared to placebo.;Secondary Objective: •?To demonstrate the superiority of secukinumab in terms of PASI 90 response at Week 12 compared to placebo. •?To assess the efficacy of secukinumab in maintaining PASI 75 response at Week 52 in subjects who were PASI 75 responders at Week 12 or IGA mod 2011 0 or 1 response at Week 52 in subjects who were IGA mod 2011 0 or 1 responders at Week 12. •?To assess the efficacy of secukinumab in terms of PASI score, IGA mod 2011 score, PASI 50/75/90/100 and IGA mod 2011 0 or 1 response over time up to Week 12 compared to placebo and over time up to Week 52 •?To assess the efficacy of secukinumab in terms of time to PASI 75 response up to Week 12 compared to placebo. •?To investigate the clinical safety and tolerability of secukinumab compared to placebo. •?To assess the efficacy of secukinumab in treating psoriatic arthritis in subjects with this comorbidity at Baseline in terms of American College of Rheumatology (ACR) 20/50/70 response over time up to Week 52. ;Primary end point(s): PASI 75 response 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 response;Timepoint(s) of evaluation of this end point: Week 12	—

Countries

China, Egypt, Hungary, Malaysia, Philippines, Thailand, Turkey

Contacts

Public ContactPublic Information Desk

Novartis Hungary Kft.

infoph.hungary@novartis.com00 36 1 457-6500

Outcome results

None listed

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