Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

NCT01807520 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457A23132012-005413-40
• Study Type: interventional
• Target: 198
• Locations: 9 countries
• Sites: 40

Brief Summary

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

Conditions

Moderate to Severe Nail Psoriasis

Keywords

Moderate nail psoriasis; Severe nail psoriasis; psoriasis; Secukinumab

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment

  The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.

  Baseline, 16 weeks

Secondary Outcomes (3)

• Percent Change From Baseline in NAPSI Score

  baseline, 16 weeks, 132 weeks

• Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132

  16 weeks, 132 weeks

• Number of Participants Who Develop Immunogenicity Against Secukinumab

  Week 132

Study Arms (3)

Secukinumab (AIN457) 150 mg

EXPERIMENTAL

Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.

Biological: Secukinumab

Secukinumab (AIN457) 300 mg

EXPERIMENTAL

Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.

Biological: Secukinumab

Placebo

PLACEBO COMPARATOR

Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.

Biological: Placebo

Interventions

Secukinumab BIOLOGICAL

Study treatment was provided in pre-filled 1 mL syringes.

Also known as: AIN457

Secukinumab (AIN457) 150 mg; Secukinumab (AIN457) 300 mg

Placebo BIOLOGICAL

Placebo was provided in pre-filled 1 mL syringes.

Also known as: placebo secukinumab

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects with chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%
• Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy

You may not qualify if:

• Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
• Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
• Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects
• Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply
• Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
• Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
• History of hypersensitivity to constituents of the study treatment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (40)

Novartis Investigative Site

Birmingham, Alabama, 35233, United States

Location

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

Location

Novartis Investigative Site

Skokie, Illinois, 60077, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46256, United States

Location

Novartis Investigative Site

High Point, North Carolina, 27262, United States

Location

Novartis Investigative Site

Portland, Oregon, 97210, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Sydney, New South Wales, 2010, Australia

Location

Novartis Investigative Site

Woolloongabba, Queensland, 4102, Australia

Location

Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Ústí nad Labem, Czech Republic, 400 11, Czechia

Location

Novartis Investigative Site

Prague, 100 34, Czechia

Location

Novartis Investigative Site

Arhus C, DK-8000, Denmark

Location

Novartis Investigative Site

Copenhagen NV, DK-2400, Denmark

Location

Novartis Investigative Site

Hellerup, DK-2900, Denmark

Location

Novartis Investigative Site

Bad Bentheim, 48455, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Münster, 48143, Germany

Location

Novartis Investigative Site

Heraklion, Crete, GR, 71110, Greece

Location

Novartis Investigative Site

Athens, 161 21, Greece

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

Location

Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28031, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

London, England, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Staffordshire, Staffordshire, WS11 5XY, United Kingdom

Location

Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Novartis Investigative Site

Birmingham, B15 2TH, United Kingdom

Location

Novartis Investigative Site

Liverpool, L14 3PE, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The overall study completed. However, in Spain, the study terminated early in accordance with study protocol amendment 1.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: March 8, 2013
• Study Start: June 20, 2013
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

GR (2); BE (2); AU (3); GB (6); CZ (2); ES (8); DE (5); US (9); DK (3)