A Study to Evaluate the Safety and Tolerability, and the Efficacy of Si-544 in Adults With Psoriasis Vulgaris or Psoriatic Arthritis

Inclusion Criteria

• •1. Subject has the capacity for consenting, was informed about the nature, the scope, and the relevance of the clinical study, voluntarily agrees in participation and in the study provisions, and duly signed the ICF approved by the ethics committee before any study-related procedure is performed
• •2. Men and women aged ≥18 to 75 years
• •3. Willing and able to adhere to the protocol requirements
• •4. Women of childbearing potential must:
• •1. have a negative pregnancy test (blood) at Screening and a negative pregnancy test (urine) at Day 1
• •2. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, from Screening through 30 days after the last IMP injection
• •Reliable methods for this study are:
• •i. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) iii. intrauterine device iv. intrauterine hormone-releasing system v. bilateral tubal occlusion vi. vasectomized sexual partner (provided that the partner is the sole sexual partner of the woman of childbearing potential and has received medical assessment of the surgical success) vii. sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) Abstinence is only accepted as true abstinence: when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods and withdrawal\] is not an acceptable method of contraception).
• •c. agree to abstain from breast feeding during the study participation and for 90 days after the last IMP injection
• •5. Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy)
• •6. Men must agree to practice true abstinence or to use a condom during sexual contact with a pregnant woman or a woman of childbearing potential during study participation and for at least 90 days after the last IMP injection, even after undergoing a successful vasectomy.
• •7. Diagnosis of Ps at least 3 months before Screening
• •8. Active Ps with ≥3% BSA involved and with at least 1 psoriatic plaque (other than nail change)
• •7\. Diagnosis of PsA based on the classification for psoriatic arthritis criteria (CASPAR) at least 3 months before Screening
• •8\. Diagnosis of active Ps with at least 1 psoriatic plaque (other than nail change)
• •9\. Active PsA defined as
• •1. ≥1 tender joint out of 68 assessed joints, and
• •2. ≥1 swollen joint out of 66 assessed joints (dactylitis of a digit counts as one joint each), and
• •3. negative results for rheumatoid factor and anti-cyclic citrullinated peptide antibodies