moderate to severe plaque psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Metotressato
Product Code: [n.d.]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: METOTREXATO
CAS Number: 59-05-2
Current Sponsor code: n.d.
Concentration unit: mg/ml mi
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject has provided informed consent. Subject is =18 and = 80 years of age at time of screening. 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). Subject has an SI index >2 for LL37 and/or ADAMTSL5 at baseline. Patients negative to LL37 and ADAMTSL5 will be included in the study to receive secukinumab but will be only clinically evaluated (PASI, IGA). Subject has involved body surface area (BSA) = 10%, PASI = 10, at baseline . For women (except those at least 2 years postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. 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 40
Exclusion criteria
Exclusion criteria: Skin disease related 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 SEE PROTOCOL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore the value of T-cell responses to LL37 and ADAMTSL5 auto-antigens in psoriasis and the impact of IL-17A inhibition on these responses.;Secondary Objective: Explore the value of LL37 and ADAMTSL5 auto-antibody formation in psoriasis and the effects of IL17A inhibition. Explore the phenotype of autoreactive T cells following IL17A inhibition by secukinumab.;Primary end point(s): T-cell Proliferation index to LL37 or ADAMTSL5 autoantigens at day 0 week 16, week 28 and at week 52.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PASI score at Weeks 16, 28 and 52 PASI 90 response at Weeks 16, 28 and 52 Presence and titer of autoantibodies against LL37 in patient’s sera. Presence and titer of autoantibodies against ADAMTSL5 in patient’s sera. Autoreactive T cells Phenotype shift to Treg;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Italy
Contacts
Public ContactDipartimento di Scienze Biomediche
IRCCS Istituto Clinico Humanitas
Outcome results
None listed