Moderate to severe psoriasis. MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: STELARA - 45 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) O,5 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 0.5ML
Product Name: Stelara
Pharmac
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has provided informed consent 2. Subject is ¿ 18 and ¿ 75 years of age at time of screening 3. Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the Investigator) 4. Subject has involved body surface area (BSA) ¿ 10%, PASI ¿ 10, at baseline 5. For women, except those at least 2 years post-menopausal (defined as no menses for 12 months without an alternative medical cause) or surgically sterile: a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. 6. Women with child bearing potential must agree to use Highly effective method of contraception during the treatment and until the end of relevant systemic exposure including: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - oral - intravaginal - transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation: - oral- injectable, - implantable; intrauterine device (IUD); intrauterine hormone-releasing system ( IUS). 7. Males with women of childbear potential partners must agree to use contraception during the treatment and until the end of relevant systemic exposure. 8. Subject has no known history of active tuberculosis • Subject has a negative test for tuberculosis during screening defined as either: • negative purified protein derivative (PPD) (=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Skin disease related 1.Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis. Other medical conditions 2.Subject has a planned surgical intervention during the duration of the study. 3.Subject has an active infection or history of infections as follows: •any active infection for which systemic anti-infectives were used within 28 days prior to first dose of investigational product •a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product •recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject 4.Subject has known history of human immunodeficiency virus 5.Hepatitis B surface antigen or Hepatitis C antibody or HIV positivity at screening 6.Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension 7.Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma 8.Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma 9.Subject has active neurological disease such as multiple sclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis or history of neurologic symptoms suggestive of central nervous system demyelinating disease 10.Subject has moderate to severe heart failure (New York Heart Association [NYHA] class III/IV) 11.Subject has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab 12.Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject Laboratory abnormalities 13.Laboratory abnormalities at screening, including any of the following: •Hemoglobin < 9 g/dL •Platelet count < 100,000/mm3 •White blood cell count < 3,000 cells/mm3 •Absolute neutrophil count (ANC) < 1000/mm3 •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ¿ 1.5 x the upper limit of normal •Creatinine clearance < 50 mL/min (Cockroft-Gault formula) •Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results Washouts and non-permitted drugs 14.Subject has used UV B therapy within 14 days before first dose of investigational product 15.Subject has used topical therapy for psoriasis as follows: •superpotent (class I) or potent (class II) topical steroids or topical anthralin within 14 days before first dose of investigational product •any other formulation or potency of topical therapy or UV B phototherapy within 14 days before first dose of investigational product (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face and intertriginous areas) 16.Subject has used the following within 28 days of first dose of investigational product: •UV A light therapy (with or without psoralen) or excimer laser; •non-biologic syste
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore the value of T-cell responses to LL37 auto-antigen in psoriasis and the impact of p40 inhibition on these responses.;Secondary Objective: Assess the correlation between presence of anti-LL37 antibodies in psoriasis and LL37-specific T-cell responses. - Exploratory objective: Correlate LL-37 autoreactive cells to SNPs in p40 encoding gene IL12B.;Primary end point(s): Explore the value of T-Cell responses to LL37 auto-antigen in psoriasis and the impact of p40 inhibition on these responses.;Timepoint(s) of evaluation of this end point: 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assess the correlation between presence of anti-LL37 antibodies in psoriasis and LL37-specific T-Cell responses.;Timepoint(s) of evaluation of this end point: 52 weeks. | — |
Countries
Italy
Contacts
Public Contactn.a.
IRCCS Istituto Clinico Humanitas
Outcome results
None listed