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 range18 Years – 75 Years

SexALL

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
✕. 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;

What they're measuring

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)

Timeframe: 8weeks

Trial details

NCT IDNCT06918743

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Shuang Li

18604031725 Shuang.li.sl100@hengrui.com

View on ClinicalTrials.gov More Psoriatic Subjects trials