A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of RSS0393 Ointment in Adult Patients With Plaque Psoriasis.

ConditionPlaque Psoriasis Subjects

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorReistone Biopharma Company Limited

About this trial

Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

RSS0393 ointment 0.03%
RSS0393 ointment placebo

Treatment groups

600 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Reistone Biopharma Company Limited

Lead sponsor

Source ClinicalTrials.gov