New ointment RSS0393 aims to clear psoriasis in major trial
NCT ID NCT07543224
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether RSS0393 ointment can improve plaque psoriasis compared to a placebo. About 600 adults with mild-to-moderate psoriasis will apply the ointment daily for 8 weeks. The main goal is to see if more people achieve clear or almost-clear skin with RSS0393 than with placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RSS0393 ointment
- What this could lead to
- If it works, this could provide a new topical treatment option for plaque psoriasis, helping to clear skin and reduce itching.
- What could go wrong
- This is a phase 3 trial, but results are not yet available. The ointment may not work better than placebo, and side effects are possible. It is not a cure, as psoriasis typically requires ongoing management.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age must be ≥18 years on the day of signing the informed consent form, male or female. 2. Body Mass Index (BMI = weight \[kg\] / height² \[m²\]) ≥18.0 kg/m² at screening. 3. A history of plaque psoriasis for ≥6 months. 4. 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: 1. 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. 2. 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: 1. Hemoglobin \<100.0 g/L (for males) or \<90.0 g/L (for females); 2. White blood cell count \<3.0 × 10⁹/L; 3. Neutrophil count \<1.5 × 10⁹/L; 4. Platelet count \<100 × 10⁹/L; 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × the upper limit of normal (ULN); 6. Total bilirubin (TBIL) \>1.5 × ULN; 7. 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; 8. 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: 1. Women who are pregnant or breastfeeding. 2. Known hypersensitivity to the investigational product or any of its excipients. 3. History or suspicion of alcohol abuse, drug abuse, or substance abuse, in the investigator's judgment. 4. 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. 5. Donation of approximately 500 mL of blood within 8 weeks prior to randomization, or plans to donate blood during the study period. 6. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality, 100730, China