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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Shuang Li
- Phone Number: 18604031725
- Email: Shuang.li.sl100@hengrui.com
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100730
- Peking Union Medical College Hospital (PUMCH)
-
Principal Investigator:
- Hongzhong Jin
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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:
1) 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.
2) 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).
3.Presence of any significant medical histories or underlying conditions that may affect safety.
4.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.
5. General Conditions:
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to the investigational product or any of its excipients.
- History or suspicion of alcohol abuse, drug abuse, or substance abuse, in the investigator's judgment.
- Administration of a live-attenuated vaccine within 12 weeks prior to randomization, intention to receive a live-attenuated vaccine during the study, or participation in a vaccine clinical trial within 12 weeks prior to randomization.
- Donation of approximately 500 mL of blood within 8 weeks prior to randomization, or plans to donate blood during the study period.
- Anticipated use of artificial or natural ultraviolet (UV) light exposure (e.g., phototherapy, tanning beds, extensive sun exposure) on the treatment areas during the study treatment period, which, in the investigator's judgment, could interfere with efficacy evaluations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment group 1: RSS0393 ointment 0.03%
|
RSS0393 ointment 0.03%
|
|
Placebo Comparator: Treatment group 2: RSS0393 ointment placebo
|
RSS0393 ointment placebo
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Achieving a Physician's Global Assessment (PGA) response at Week 8
Time Frame: week8
|
week8
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of participants achieving at least a 75% improvement frombaseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75).
Time Frame: week54
|
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).
Time Frame: week54
|
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.
Time Frame: week54
|
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.
Time Frame: week 54
|
week 54
|
|
Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit.
Time Frame: week 54
|
week 54
|
|
The proportion of participants achieving PASI 50, PASI 90, or PASI 100 at each visit.
Time Frame: week 54
|
week 54
|
|
Change from baseline in the Itch Numerical Rating Scale (Itch-NRS) score (absolute and percentage) at each visit.
Time Frame: week 54
|
week 54
|
|
Change from baseline in Body Surface Area (BSA) involvement (absolute and percentage) at each visit.
Time Frame: week 54
|
week 54
|
|
Change from baseline in the Dermatology Life Quality Index (DLQI) at each visit.
Time Frame: week 54
|
week 54
|
|
Adverse Event (AE)
Time Frame: week 54
|
week 54
|
|
Local Tolerability Score
Time Frame: week 54
|
week 54
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- RSS0393Oint-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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