The main objective of this study is to investigate the safety and tolerability of si-544. Other objectives are to study the metabolism of si-544 in the body and to assess the effects of si-544 on cells of the body's immune system (immune cells) that have been chronically activated by the disease. Likewise, the effect of si-544 on inflammatory responses in the body triggered by the disease and other disease symptoms will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Subcutaneous injection in the abdomen
Subcutaneous injection in the abdomen
selectION Clinical Trial Site
Bad Bentheim, Germany
selectION Clinical Trial Site
Berlin, Germany
selectION Clinical Trial Site
Blankenfelde-Mahlow, Germany
selectION Clinical Trial Site
Hamburg, Germany
Determination of safety and tolerability of treatment with si-544
Occurrence of adverse events (AEs) and serious AEs (SAEs), including description of type, frequency, severity, and causal relationship of adverse events (AEs) and serious AEs
Time frame: From Day -35 to Day 106
Determination of safety and tolerability of treatment with si-544
Change in clinical laboratory, electrocardiogram (ECG), vital signs, and peripheral oxygen saturation from Baseline to all assessed timepoints
Time frame: From Day 1 (Baseline) to Day 106
Determination of the plasma concentrations of free si-544
Plasma concentrations of free si-544
Time frame: Day 1 (Baseline) and Day 25
Determination of the pharmacodynamics (PD) of si-544 as assessed by the number of T cells in peripheral blood
Change in the number of T cells in peripheral blood
Time frame: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the pharmacodynamics (PD) of si-544 as assessed by immunophenotypes of T cell subsets
Change in immunophenotypes of T cell subsets
Time frame: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the pharmacodynamics (PD) of si-544 as assessed by serum cytokine levels
Change in serum cytokine levels
Time frame: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the immunogenicity of si-544 treatment
Change in anti-drug antibodies against si-544 in serum
Time frame: From Day 1 (Baseline) to Day 29 (Week 5) and Week 16
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI)
Change in the psoriasis area and severity index (PASI)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI) response rate
Difference in psoriasis area and severity index (PASI) response rate (defined as subjects with ≥1 score improvement from Baseline)
Time frame: At Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by physician's global assessment (PGA) of disease activity
Change in the physician's global assessment (PGA) of disease activity
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by body surface area (BSA)
Change in affected body surface area (BSA)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by a numeric rating scale (NRS)
Change in the mean itch using a numeric rating scale (NRS)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by a numeric rating scale (NRS)
Change in the worst itch using a numeric rating scale (NRS)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriasis vulgaris (Ps) in Ps patients only as assessed by dermatological life quality index (DLQI)
Change in the dermatological life quality index (DLQI)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assessed by psoriatic arthritis quality of life (PsAQoL)
Change in the psoriatic arthritis quality of life (PsAQoL)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only (assessment of pain)
Change in the subject's assessment of pain using a visual analog scale (VAS)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assesses by the 66 swollen joint count (SJC66)
Change in the 66 swollen joint count (SJC66)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assessed by the 68 tender joint count (TJC68)
Change in the 68 tender joint count (TJC68)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.