Moderate to severe psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Skyrizi
Product Name: Risankizumab
Product Code: [na]
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Risankizumab
CAS Number: 1612838-76-2
Current Sponsor
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 (e.g., no morphology changes or significant flares of disease activity in the opinion of the Investigator) 4. Subject has involved body surface area (BSA) ¿ 10% and PASI ¿ 12 at baseline 5. Subject candidates to risankizumab therapy according to local label 6. Subject is able to complete study procedures, including self-assessments and self-injections 7. Subjects who responded with T-lymphocytes proliferation to the psoriasis autoantigen LL37 or ADAMTSL5. 8. Subject is male or a woman not of child-bearing potential, including: a. infertile patients due to surgical sterilization, congenital anomalies b. OR postmenopausal, defined as: a woman of at least 50 years of age with an intact uterus, not on hormone therapy, who has either: i. Cessation of menses for at least 1 year ii. OR At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone level of >40 mIU/mL c. OR A woman of 55 years or older not on hormone therapy who has had at least 6 months of spontaneous amenorrhea d. OR A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy 9. Subject is a woman of child-bearing potential and: a. Must test negative for pregnancy prior to first dose in Study b. Must agree to either remain abstinent, if complete abstinence is their preferred and usual lifestyle, or remain in same-sex relationships, if part of their preferred and usual lifestyle, or without sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception. c. OR Must use 2 effective methods of contraception for the entirety of the study. Abstinence or contraception must continue for 21 weeks following completion of investigational product administration i. Two effective methods of contraception (such as male or female condoms with spermicide, diaphragms with spermicide or cervical sponges) will be used. The patient may choose to use a double-barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not considered acceptable due to the high failure rate when these methods are combined. ii. Of note, 1 of the 2 methods of contraception may be a highly effective (less than 1% failure rate) method of contraception (such as, combination oral contraceptives, implanted contraceptives or intrauterine devices). 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
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 (e.g., 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 a known history of human immunodeficiency virus 4. Hepatitis B surface antigen or Hepatitis C antibody positivity at screening 5. Patient is hepatitis B core antibody positive (HBcAb +) but HbsAg and HBsAb negative 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 any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject 10. Has active TB or orther serious infection 11. Has received, or is expected to receive, any live virus or bacterial vaccinatrion within 4 weeks before the first administration of study intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore the effects of SKYRIZI on autoantigen-specific T-cell development and activation as measured by LL37 and ADAMTSL5 antigens by antigenic-specific proliferation assay at 28 weeks with respect to baseline;Secondary Objective: To assess and evaluate over 52 weeks of SKYRIZI treatment: •Psoriasis severity •Frequency and phenotype of autoreactive T-cells •Frequency of LL37 and ADAMTSL5 T-cells •Correlation between clinical response and frequency of autoreactive T-cells.;Primary end point(s): Proportion of activated autoantigen-specific T-cells as measured by LL37 and ADAMTSL5 antigens by antigenic-specific proliferation assay at 28 weeks with respect to baseline.;Timepoint(s) of evaluation of this end point: 28 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): At each timepoint the following will be described: • Change from baseline of PASI, BSA, IGA score (psoriasis severity indexes) – (0/4/16/28/40/52weeks) • Frequency and phenotype of autoreactive T cells by proliferation assay and flow cytometry – (0/16/28/52weeks) • Frequency of T-cells directed against LL37 and ADAMTSL5 by tetramers staining - (0/16/28/52weeks) • Correlation between the clinical response and the frequency of autoreactive T-cells - (0/16/28/52weeks);Timepoint(s) of evaluation of this end point: nd | — |
Countries
Italy
Contacts
Public ContactN.A.
IRCCS Istituto Clinico Humanitas
Outcome results
None listed