Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis

A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003086-34-SE

Enrollment

210

Registered

2013-11-22

Start date

2013-12-04

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe chronic palmoplantar pustular psoriasis MedDRA version: 16.1 Level: PT Classification code 10037575 Term: Pustular psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 16.1 Level: LLT Classification code 10037158 Term: Psoriasis palm & soles System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Other descriptive name: SECUK

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Palmoplantar pustular psoriasis for at least 6 months before Randomization; the medical history should confirm the presence of pustules in the last 6 months if not present at the time of screening. - 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 Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 189 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

Exclusion criteria: - Forms of psoriasis other than chronic plaque psoriasis and palmoplantar pustular 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 exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of secukinumab 150 mg s.c. and/or 300 mg s.c. in patients with moderate to severe chronic palmoplantar pustular psoriasis at Week 16 with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) compared to placebo.;Secondary Objective: 1/To demonstrate the superiority of secukinumab 150 mg s.c. and/or 300 mg s.c in patients with moderate to severe chronic palmoplantar pustular psoriasis at Week 16 with respect to the mean change from Baseline of palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI), compared to placebo. 2/To evaluate the time courses of the mean ppPASI response rates until Week 16 (secukinumab 150 mg s.c. and 300 mg s.c. compared to placebo), and over time until week 52. 3/ To evaluate the clinical safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, electrocardiograms (ECGs), and adverse events monitoring.;Primary end point(s): palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: To demonstrate the superiority of secukinumab 150 mg s.c. and/or 300 mg s.c. in patients with moderate to severe chronic palmoplantar pustular psoriasis at Week 16 with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate (ppPASI 75) compared to placebo.;Secondary Objective: 1/To demonstrate the superiority of secukinumab 150 mg s.c. and/or 300 mg s.c in patients with moderate to severe chronic palmoplantar pustular psoriasis at Week 16 with respect to the mean change from Baseline of palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI), compared to placebo. 2/To evaluate the time courses of the mean ppPASI response rates until Week 16 (secukinumab 150 mg s.c. and 300 mg s.c. compared to placebo), and over time until week 52. 3/ To evaluate the clinical safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, electrocardiograms (ECGs), and adverse events monitoring.;Primary end point(s): palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate;Timepoint(s) of evaluation of this end point: Week 16

—

Secondary

Measure	Time frame
Secondary end point(s): 1/ mean change from Baseline of palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) 2/ mean ppPASI response rates ;Timepoint(s) of evaluation of this end point: 1/ week 16 2/ week 16 & over time till week 52	—

Countries

Austria, Belgium, France, Germany, Italy, Poland, Russian Federation, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026