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

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2013-003086-34-ES
• Date of registration: 05/12/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• 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.
• Date of first enrolment: 09/12/2013
• 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

Contacts

• Name: Departamento Médico (HOR-MK)
• Affiliation: Novartis Farmacéutica S.A.

• Name: Departamento Médico (HOR-MK)
• Affiliation: Novartis Farmacéutica S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients must be able to understand and communicate with the
investigator and comply with the requirements of the study (including administration of s.c. injections at home) and must give a written, signed and dated informed consent, before any study-related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
2. Men or women ? 18 years of age at time of screening
3. Palmoplantar pustular psoriasis for at least 6 months before
randomization; the medical history should confirm the presence of
pustules in the last six months if not present at the time of screening
4. Moderate to severe palmoplantar pustular psoriasis as defined at
Baseline by:
? ppPASI score of ? 12 and
? DLQI ? 10
5. Candidate for systemic therapy, defined as having palmoplantar
pustular psoriasis inadequately controlled by:
? Topical treatment and/or
? Phototherapy, and/or
? Previous systemic therapy
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:
1. Forms of psoriasis other than chronic plaque psoriasis and palmoplantar pustular psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)
2. Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis on the hands and/or feet
3. Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
4. 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 (Table 5-2).
5. Previous exposure to any biologic drug directly targeting IL-17A or IL- 17RA Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
7. Women of child-bearing potential, unless they are using effective methods of contraception during the study and for 16 weeks after study treatment discontinuation
8. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
9. 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.
10. Underlying condition (including, but not limited to metabolic,
hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy
11. Screening total WBC count <2.500/?l, or thrombocytes <100.000/?l, or neutrophils <1.500/?l, or hemoglobin <8.5 g/dl
12. Chest X-ray, computerized tomography (CT scan), or MRI with evidence of ongoing infectious or malignant process, obtained within 12 weeks prior to randomization, and evaluated by a qualified physician
13. Active systemic infections during the last two weeks (exception: common cold) prior to randomization or any infection that reoccurs on a regular basis
14. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) completed within 12 weeks prior to randomization and establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines prior to randomization
15. Past medical history record of HIV, hepatitis B or hepatitis C prior to randomization
16. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of reoccurrence in the past 12 weeks prior to randomization; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
17. Inability or unwillingness to undergo repeated venipuncture (e.

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: 14.1 Level: PT Classification code 10037575 Term: Pustular psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1 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: Suspension for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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

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.

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

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

Secondary Outcome(s)

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

Secondary ID(s)

CAIN457A3301

2013-003086-34-SE

Source(s) of Monetary Support

Novartis Pharma Services AG