To Evaluate the Efficacy and Safety of RSS0393 Ointment in Patients With Plaque Psoriasis Phase II Study

NCT06918743 | Not Yet Recruiting Phase 2

• 1 other identifier: RSS0393Oint-201
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of RSS0393 ointment in patients with plaque psoriasis Phase II study

Conditions

Psoriatic Subjects

Outcome Measures

Primary Outcomes (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)

  8weeks

Secondary Outcomes (11)

• Proportion of participants who achieved at least 75% improvement (PASI 75) from baseline;

  14weeks

• The proportion of subjects with PGA response at each visit

  14weeks

• Absolute and percentage changes in PASI scores at each visit compared to baseline;

  14weeks

• The proportion of subjects who achieved PGA 0 or 1 score at each visit

  14weeks

• The time of the subject reached PASI 50 within 12 weeks

  14weeks

Study Arms (3)

Treatment group 1

EXPERIMENTAL

RSS0393 ointment 0.01%

Drug: RSS0393 ointment

Treatment group 2

EXPERIMENTAL

RSS0393 ointment 0.03%

Drug: RSS0393 ointment

Treatment group 3

PLACEBO COMPARATOR

RSS0393 ointment placebo

Drug: RSS0393 ointment placebo

Interventions

RSS0393 ointment DRUG

RSS0393 ointment 0.01%

Treatment group 1

RSS0393 ointment placebo DRUG

RSS0393 ointment placebo

Treatment group 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• had any surgery within 1 month prior to screening, or had not recovered as determined by the investigator, or planned any surgery during the study period;
• Currently has an active tuberculosis infection, or chest radiography indicates the presence of an active tuberculosis infection;
• any serious, progressive, uncontrolled cardiovascular or cerebrovascular, respiratory, liver, kidney, gastrointestinal, blood, neurological, or psychiatric disorders, or medical measures, medical conditions, etc. that may affect study participation, or may place subjects at undue risk, as determined by the investigator;
• At the time of screening, laboratory tests and/or 12-lead electrocardiogram showed the following:
• Hemoglobin \< 100.0 g/L (male) or \< 90.0 g/L (female);
• White blood cell count \< 3.0×109/L;
• Neutrophil count \< 1.5×109/L;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Shuang Li

CONTACT

18604031725; Shuang.li.sl100@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 9, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-02