Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.
Age must be ≥18 years on the day of signing the informed consent form, male or female.
Body Mass Index (BMI = weight [kg] / height² [m²]) ≥18.0 kg/m² at screening.
A history of plaque psoriasis for ≥6 months.
Body Surface Area (BSA) involvement of psoriasis lesions between 2% and 20%, and a Psoriasis Area and Severity Index (PASI) score ≥2, and a Physician's Global Assessment (PGA) score ≥2 at both screening and baseline.
Hemoglobin <100.0 g/L (for males) or <90.0 g/L (for females);
White blood cell count <3.0 × 10⁹/L;
Neutrophil count <1.5 × 10⁹/L;
Platelet count <100 × 10⁹/L;
Parallel
RSS0393 ointment 0.03%
DrugRSS0393 ointment 0.03%
RSS0393 ointment placebo
DrugRSS0393 ointment placebo
Achieving a Physician's Global Assessment (PGA) response at Week 8
The proportion of participants achieving at least a 75% improvement frombaseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75).
The proportion of participants with a baseline Itch Numerical Rating Scale (Itch-NRS) score ≥4 who achieved an Itch-NRS response (defined as a reduction of ≥4 points from baseline).
Achieving an Intertriginous Physician's Global Assessment (I-PGA) response in participants with baseline involvement of intertriginous areas and a baseline I-PGA score ≥ 2.
The proportion of participants achieving a Physician's Global Assessment (PGA) response (score of "clear" or "almost clear") at each of the other scheduled visits.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
