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.

NCT07543224 | Not Yet Recruiting Phase 3

• 1 other identifier: RSS0393Oint-301
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis Subjects

Outcome Measures

Primary Outcomes (1)

• Achieving a Physician's Global Assessment (PGA) response at Week 8

  week8

Secondary Outcomes (11)

• The proportion of participants achieving at least a 75% improvement frombaseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75).

  week54

• 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).

  week54

• 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.

  week54

• 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.

  week 54

• Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit.

  week 54

Study Arms (2)

Treatment group 1: RSS0393 ointment 0.03%

EXPERIMENTAL

Drug: RSS0393 ointment 0.03%

Treatment group 2: RSS0393 ointment placebo

PLACEBO COMPARATOR

Drug: RSS0393 ointment placebo

Interventions

RSS0393 ointment 0.03% DRUG

RSS0393 ointment 0.03%

Treatment group 1: RSS0393 ointment 0.03%

RSS0393 ointment placebo DRUG

RSS0393 ointment placebo

Treatment group 2: RSS0393 ointment placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of any of the following skin abnormalities or conditions:
• The participant is diagnosed with skin diseases or conditions other than plaque psoriasis during the screening period that, in the investigator's opinion, may interfere with the evaluation of study-related endpoints.
• Use of any of the following medications or participation in clinical studies:
• \) Treatment with topical anti-psoriatic medications within 14 days prior to baseline, or systemic anti-psoriatic therapies or phototherapy within 28 days prior to baseline, or biologics for psoriasis within the protocol-specified washout period prior to baseline.
• \) Participation in any clinical study (including investigational vaccines) or medical device trial within 3 months prior to baseline or within 5 elimination half-lives of the prior investigational product (whichever is longer).
• Presence of any significant medical histories or underlying conditions that may affect safety.
• Any of the following laboratory abnormalities and/or 12-lead ECG findings at screening/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;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × the upper limit of normal (ULN);
• Total bilirubin (TBIL) \>1.5 × ULN;
• Estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (MDRD) study equation \<60 mL/min/1.73 m², or serum creatinine outside the normal range, and considered by the investigator as unsuitable for study participation;
• Positive test for hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, syphilis antibody, or anti-hepatitis C virus (HCV) antibody; OR a 12-lead ECG showing clinically significant abnormalities that may affect participant safety.

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (1)

Peking Union Medical College Hospital (PUMCH)

Beijing, Beijing Municipality, 100730, China

Location

Central Study Contacts

Shuang Li

CONTACT

18604031725; Shuang.li.sl100@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-02

Locations

CN (1)