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

NCT03066609 | Completed Phase 3 Results DMC

• 1 other identifier: CAIN457A2318
• Study Type: interventional
• Target: 543
• Locations: 6 countries
• Sites: 32

Brief Summary

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

Conditions

Plaque Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)

  Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

  Week 12

• Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)

  Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.

  Week 12

Secondary Outcomes (6)

• Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)

  Week 12

• Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)

  Week 52

• Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)

  Week 52

• PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)

  week 1, week 12, week 24, week 52

• American Collage of Rheumatology (ACR) Response 20/50/70

  week 12, week 24, week 52

Study Arms (3)

Secukinumab 150mg

EXPERIMENTAL

Secukinumab 150mg s.c.

Drug: Secukinumab 150 mg s.c.

Secukinumab 300mg

EXPERIMENTAL

Secukinumab 300mg s.c.

Drug: Secukinumab 300 mg s.c.

Placebo

PLACEBO COMPARATOR

Placebo to secukinumab s.c

Drug: Placebo

Interventions

Secukinumab 150 mg s.c. DRUG

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

Secukinumab 150mg

Secukinumab 300 mg s.c. DRUG

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

Secukinumab 300mg

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must give a written, signed and dated informed consent.
• Men or women at least 18 years of age at time of screening.
• Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
• 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.
• 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.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
• Drug-induced 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.
• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (32)

Novartis Investigative Site

Beijing, Beijing Municipality, 100039, China

Location

Novartis Investigative Site

Xicheng Direct, Beijing Municipality, 100044, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Changchun, Jilin, 130021, China

Location

Novartis Investigative Site

Dalian, Liaoning, 116011, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110000, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310009, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310014, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310016, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Guangzhou, 510000, China

Location

Novartis Investigative Site

Guangzhou, 510080, China

Location

Novartis Investigative Site

Nanjing, 210042, China

Location

Novartis Investigative Site

Shanghai, 200040, China

Location

Novartis Investigative Site

Shanghai, 200433, China

Location

Novartis Investigative Site

Tianjin, 300052, China

Location

Novartis Investigative Site

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Novartis Investigative Site

Kaposvár, 7400, Hungary

Location

Novartis Investigative Site

Orosháza, 5900, Hungary

Location

Novartis Investigative Site

George Town, Pulau Pinang, 10990, Malaysia

Location

Novartis Investigative Site

Batu Caves, 68100, Malaysia

Location

Novartis Investigative Site

Makati City, 1220, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Bangkoknoi, Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Pendik / Istanbul, Turkey, 34899, Turkey (Türkiye)

Location

Novartis Investigative Site

Aydin, 09100, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35340, Turkey (Türkiye)

Location

Novartis Investigative Site

Manisa, 45040, Turkey (Türkiye)

Location

Novartis Investigative Site

Mersin, 33079, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33060370 DERIVED

MeSH Terms

Conditions

Skin Diseases; Pruritus; Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 28, 2017
• Study Start: February 28, 2017
• Primary Completion: December 21, 2017
• Study Completion: November 20, 2018
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2019-12

Locations

HU (3); TU (5); MY (2); PH (2); TH (3); CN (17)