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Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

NCT ID: NCT03066609

Last Updated: 2019-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2018-11-20

Brief Summary

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The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Detailed Description

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Conditions

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Plaque Psoriasis

Keywords

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Plaque psoriasis Secukinumab Skin condition skin disease itching psoriasis vulgaris immune-mediated systemic disease skin lesions scaly patches papules psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Secukinumab 150mg

Secukinumab 150mg s.c.

Group Type EXPERIMENTAL

Secukinumab 150 mg s.c.

Intervention Type DRUG

150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Secukinumab 300mg

Secukinumab 300mg s.c.

Group Type EXPERIMENTAL

Secukinumab 300 mg s.c.

Intervention Type DRUG

300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Placebo

Placebo to secukinumab s.c

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48

Interventions

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Secukinumab 150 mg s.c.

150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Intervention Type DRUG

Secukinumab 300 mg s.c.

300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48

Intervention Type DRUG

Placebo

Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects must give a written, signed and dated informed consent.
2. Men or women at least 18 years of age at time of screening.
3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
4. Moderate to severe psoriasis as defined at Baseline by:

* PASI score of 12 or greater, and
* IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

* topical treatment and/or,
* phototherapy and/or,
* previous systemic therapy.

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
2. Drug-induced psoriasis.
3. Ongoing use of prohibited treatments.
4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. 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.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status

Novartis Investigative Site

Xicheng Direct, Beijing Municipality, China

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Changchun, Jilin, China

Site Status

Novartis Investigative Site

Dalian, Liaoning, China

Site Status

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Novartis Investigative Site

Nanjing, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Tianjin, , China

Site Status

Novartis Investigative Site

Kecskemét, Bács-Kiskun county, Hungary

Site Status

Novartis Investigative Site

Kaposvár, , Hungary

Site Status

Novartis Investigative Site

Orosháza, , Hungary

Site Status

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Site Status

Novartis Investigative Site

Batu Caves, , Malaysia

Site Status

Novartis Investigative Site

Makati City, , Philippines

Site Status

Novartis Investigative Site

Quezon City, , Philippines

Site Status

Novartis Investigative Site

Bangkoknoi, Bangkok, Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Pendik / Istanbul, Turkey, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Aydin, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Manisa, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Mersin, , Turkey (Türkiye)

Site Status

Countries

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China Hungary Malaysia Philippines Thailand Turkey (Türkiye)

References

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Cai L, Zhang JZ, Yao X, Gu J, Liu QZ, Zheng M, Zhang SF, Xu JH, Li CX, Cheng H, Guo Q, Pan WL, Li SQ, Li RY, Guo ZP, Song ZQ, Li SS, Dong XQ, Wang L, Fu R, Regnault P, Charef P, Mazur R, Patekar M. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis. Chin Med J (Engl). 2020 Nov 20;133(22):2665-2673. doi: 10.1097/CM9.0000000000001163.

Reference Type DERIVED
PMID: 33060370 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CAIN457A2318

Identifier Type: -

Identifier Source: org_study_id