Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Novartis

Status and phase: Completed; Phase 3

Conditions: Palmoplantar Pustular Psoriasis

Treatments: Biological: Secukinumab 300mg; Biological: Placebo; Biological: Secukinumab 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02008890

CAIN457A3301

2013-003086-34 (EudraCT Number)

Details and patient eligibility

About

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Palmoplantar pustular psoriasis for at least 6 months before Randomization

• Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:

  • ppPASI score of ≥ 12 and
  • DLQI ≥ 10

• Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:

  • Topical treatment, and/or
  • Phototherapy, and/or
  • Previous systemic therapy

Exclusion criteria

• Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
• Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
• Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
• Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
• Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
• Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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237 participants in 3 patient groups, including a placebo group

Secukinumab 300mg

Experimental group

Description:

Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.

Treatment:

Biological: Placebo

Biological: Secukinumab 300mg

Secukinumab 150mg

Experimental group

Description:

Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.

Treatment:

Biological: Placebo

Biological: Secukinumab 150mg

Placebo

Placebo Comparator group

Description:

Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.

Treatment:

Biological: Placebo

Biological: Secukinumab 150mg

Biological: Secukinumab 300mg