To Evaluate the Efficacy and Safety of RSS0393 Ointment in Patients With Plaque Psoriasis Phase I… (NCT06918743) | Clinical Trial Compass
Not Yet RecruitingPhase 2
To Evaluate the Efficacy and Safety of RSS0393 Ointment in Patients With Plaque Psoriasis Phase II Study
147 participantsStarted 2025-04
Plain-language summary
To evaluate the efficacy and safety of RSS0393 ointment in patients with plaque psoriasis Phase II study
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The age of signing the informed consent must be ≥18 years old and ≤75 years old, male or female
. At screening, body mass index \[BMI= weight (kg)/height 2 (m2)\]≥18.0kg/m2
. A history of plaque psoriasis ≥6 months prior to randomization
. At screening and baseline, the BSA of the affected area was 2%-20% (including both ends), PASI score ≥2, PGA score ≥2.
. The subject voluntarily signs informed consent before the start of any procedures related to the study, is able to communicate with the investigator smoothly, understands and is willing to complete the study in strict compliance with the requirements of the clinical study protocol;
. A fertile female subject or a male subject whose partner is a fertile woman who has not had a child, plans to donate sperm/eggs from the date of signing the informed consent to 8 weeks after the last dose, and voluntarily uses highly effective contraceptive methods
Exclusion criteria
. Present with any of the following medical history or concomitant diseases:
. Diagnosis of other types of psoriasis other than plaque psoriasis during subject screening, Such as guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, articular psoriasis, or drug-induced psoriasis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with a clinician's overall assessment (PGA) response (defined as a PGA score of 0 (clear) or 1 (nearly clear) with ≥2 points improvement from baseline)
. the subject has other skin diseases or conditions that the investigator determines may affect the evaluation of the relevant endpoint of this study
. any other persistent active autoimmune disease, Including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma or polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjogren's syndrome, immune deficiency syndromes (such as Felty's syndrome);
. There are the following important medical history or underlying diseases that affect safe
. The subject has a history of any active malignancy or malignancy in the 5 years prior to the screening visit, except skin squamous cell carcinoma or basal cell carcinoma or cervical cancer in situ that has been cured after treatment;
. Participants with a history of depression and/or who were clinically deemed to be at risk of suicide during the screening and baseline periods;
. Active infection within 2 weeks prior to baseline requiring systemic anti-infective therapy, or severe infection or systemic infection within 4 weeks prior to baseline requiring intravenous anti-infective therapy or hospitalization due to infection, or other chronic, recurrent, or active infections deemed by the investigator not suitable for participation in the study;