Plaque Psoriasis SubjectsPhase 3NCT07543224
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.
A Phase 3 study testing RSS0393 ointment 0.03% in people with Plaque Psoriasis Subjects, run by Reistone Biopharma Company Limited at 1 site in China.
Trial summary
Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis Subjects
- What is being tested?
- RSS0393 ointment 0.03%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality, 100730
Hongzhong Jin
About this study
Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.
- Conditions
- Plaque Psoriasis Subjects
- Being tested
- RSS0393 ointment 0.03%, RSS0393 ointment placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSS0393 ointment 0.03%Drug
RSS0393 ointment 0.03%
RSS0393 ointment placeboDrug
RSS0393 ointment placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: RSS0393 ointment 0.03% | Experimental | Not described Receives: Drug: RSS0393 ointment 0.03% |
| Treatment group 2: RSS0393 ointment placebo | Placebo comparator | Not described Receives: Drug: RSS0393 ointment placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving a Physician's Global Assessment (PGA) response at Week 8
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: week 54
Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit.
Measured: week 54
The proportion of participants achieving PASI 50, PASI 90, or PASI 100 at each visit.
Measured: week 54
Change from baseline in the Itch Numerical Rating Scale (Itch-NRS) score (absolute and percentage) at each visit.
Measured: week 54
Change from baseline in Body Surface Area (BSA) involvement (absolute and percentage) at each visit.
Measured: week 54
Change from baseline in the Dermatology Life Quality Index (DLQI) at each visit.
Measured: week 54
Adverse Event (AE)
Measured: week 54
Local Tolerability Score
Measured: week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Psoriasis SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543224
- Sponsor's protocol ID
- RSS0393Oint-301
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07543224
- Acronym / sponsor ID
- RSS0393Oint-301
- Conditions
- Plaque Psoriasis Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSS0393 ointment 0.03%RSS0393 ointment 0.03% | Drug | Treatment group 1: RSS0393 ointment 0.03% |
| RSS0393 ointment placeboRSS0393 ointment placebo | Drug | Treatment group 2: RSS0393 ointment placebo |
Primary outcome
Achieving a Physician's Global Assessment (PGA) response at Week 8
Time frame: week8
11 secondary outcomes
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
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
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
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
Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit.
Time frame: week 54
The proportion of participants achieving PASI 50, PASI 90, or PASI 100 at each visit.
Time frame: week 54
Change from baseline in the Itch Numerical Rating Scale (Itch-NRS) score (absolute and percentage) at each visit.
Time frame: week 54
Change from baseline in Body Surface Area (BSA) involvement (absolute and percentage) at each visit.
Time frame: week 54
Change from baseline in the Dermatology Life Quality Index (DLQI) at each visit.
Time frame: week 54
Adverse Event (AE)
Time frame: week 54
Local Tolerability Score
Time frame: week 54
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSS0393 ointment 0.03% in people with Plaque Psoriasis Subjects, run by Reistone Biopharma Company Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Li (18604031725, Shuang.li.sl100@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving a Physician's Global Assessment (PGA) response at Week 8 (time frame: week8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.