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

NCT01806597 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457A23122012-005412-25
• Study Type: interventional
• Target: 205
• Locations: 15 countries
• Sites: 54

Brief Summary

Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.

Conditions

Moderate to Severe Palmoplantar Psoriasis

Keywords

Skin condition, itching, psoriasis vulgaris, relapsing remitting psoriasis, immune-med systemic disease, skin lesions, scaly patches, papules, plaques

Outcome Measures

Primary Outcomes (1)

• Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment

  palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.

  Week 16

Secondary Outcomes (6)

• Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I

  Week 1, week 2, week 4, week, 8, week 12, week 16

• Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II

  Week 16, Week 20, Week 28, Week 32, Week 64, Week 132

• Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period

  Week 16, Week 24, Week 28, Week 80

• Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I

  Week 1, Week 2, Week 4, Week 8, Week 12, Week 16

• Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set

  Week 16, Week 32, Week 80, Week 132

Study Arms (3)

secukinumab 150mg

EXPERIMENTAL

201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg were dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

Biological: secukinumab 150 mg

secukinumab 300 mg

EXPERIMENTAL

201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg were dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections.

Biological: secukinumab 300 mg

Placebo

PLACEBO COMPARATOR

201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo were dosed weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders continued to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders were randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo were either terminated their participation, if ppIGA responders, or randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment were administered by sub-cutaneous injections.

Biological: Placebo

Interventions

secukinumab 150 mg BIOLOGICAL

Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.

Also known as: AIN457 150 mg

secukinumab 150mg

secukinumab 300 mg BIOLOGICAL

Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.

Also known as: AIN457 300 mg

secukinumab 300 mg

Placebo BIOLOGICAL

Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.

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 and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
• 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 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
• Use of 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
• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
• History of hypersensitivity to constituents of the study treatment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (54)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

Location

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46256, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40291, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02111, United States

Location

Novartis Investigative Site

Verona, New Jersey, 07044, United States

Location

Novartis Investigative Site

High Point, North Carolina, 27262, United States

Location

Novartis Investigative Site

Goodlettsville, Tennessee, 37072-2301, United States

Location

Novartis Investigative Site

Sydney, New South Wales, 2010, Australia

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Novartis Investigative Site

Woolloongabba, Queensland, 4102, Australia

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Novartis Investigative Site

Carlton, Victoria, 3053, Australia

Location

Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

Location

Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Calgary, Alberta, T2S 3B3, Canada

Location

Novartis Investigative Site

Barrie, Ontario, L4M 6L2, Canada

Location

Novartis Investigative Site

London, Ontario, N6A 3H7, Canada

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Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

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Novartis Investigative Site

Montreal, Quebec, H3Z 2S6, Canada

Location

Novartis Investigative Site

Helsinki, 00250 HUS, Finland

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Novartis Investigative Site

Tampere, 33100, Finland

Location

Novartis Investigative Site

Budapest, 1134, Hungary

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Novartis Investigative Site

Debrecen, 4032, Hungary

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Novartis Investigative Site

Miskolc, 3529, Hungary

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Novartis Investigative Site

Szeged, H-6725, Hungary

Location

Novartis Investigative Site

Afula, 1834111, Israel

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Tel Aviv, 6209804, Israel

Location

Novartis Investigative Site

Tel Aviv, 64239, Israel

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Novartis Investigative Site

Breda, CK, 4818, Netherlands

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Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

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Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

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Novartis Investigative Site

Stavanger, 4068, Norway

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Novartis Investigative Site

Coimbra, 3000-075, Portugal

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Novartis Investigative Site

Lisbon, 1649-035, Portugal

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Novartis Investigative Site

Lisbon, 1998 - 018, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

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Novartis Investigative Site

Porto, 4200 319, Portugal

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Novartis Investigative Site

Kazan', 420012, Russia

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Novartis Investigative Site

Moscow, 107076, Russia

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Novartis Investigative Site

Moscow, 119071, Russia

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Novartis Investigative Site

Saint Petersburg, 194044, Russia

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Novartis Investigative Site

Kosice-Saca, Slovak Republic, 040 15, Slovakia

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Novartis Investigative Site

Košice, 04011, Slovakia

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Novartis Investigative Site

Svidník, 089 01, Slovakia

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Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

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Novartis Investigative Site

Las Palmas de Gran Canaria, Las Palmas de G.C, 35010, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Novartis Investigative Site

Fatih / Istanbul, Turkey, 34093, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, 06500, Turkey (Türkiye)

Location

Novartis Investigative Site

Gaziantep, 27310, Turkey (Türkiye)

Location

Novartis Investigative Site

London, England, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

MeSH Terms

Conditions

Skin Diseases; Pruritus; Plaque, Amyloid

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

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 7, 2013
• Study Start: June 19, 2013
• Primary Completion: November 2, 2016
• Study Completion: November 2, 2016
• Last Updated: February 22, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-01

Locations

US (8); BE (2); CA (5); IL (4); GB (2); TU (4); NL (3); HU (4); AU (4); NO (1); RU (4); PT (5); SL (3); FI (2); ES (3)