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

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2013-003086-34-PL
• Date of registration: 10/03/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular Psoriasis
• Scientific title: 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 - amended with an optional extension treatment period of up to a total of 148 weeks
• Date of first enrolment: 18/04/2014
• Target sample size: 210
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003086-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 17.1 Level: PT Classification code 10037575 Term: Pustular psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1 Level: LLT Classification code 10037158 Term: Psoriasis palm & soles System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Intervention(s)

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: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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 and week 148.
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.

Timepoint(s) of evaluation of this end point: Week 16

Primary end point(s): palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate

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 Outcome(s)

Timepoint(s) of evaluation of this end point: 1/ week 16
2/ week 16, over time till week 52 and week 148.

Secondary end point(s): 1/ mean change from Baseline of palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI)
2/ mean ppPASI response rates

Secondary ID(s)

CAIN457A3301

2013-003086-34-SE

Source(s) of Monetary Support

Novartis Pharma Services AG