NCT07543224尚未招募3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Achieving a Physician's Global Assessment (PGA) response at Week 8
研究概览
简要总结
Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Treatment group 2: RSS0393 ointment placebo
Placebo Comparator
干预措施: RSS0393 ointment placebo (Drug)
Treatment group 1: RSS0393 ointment 0.03%
Experimental
干预措施: RSS0393 ointment 0.03% (Drug)
结局指标
主要结局
Achieving a Physician's Global Assessment (PGA) response at Week 8
时间窗: week8
次要结局
- Local Tolerability Score(week 54)
- The proportion of participants achieving at least a 75% improvement frombaseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75).(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).(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.(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.(week 54)
- Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit.(week 54)
- The proportion of participants achieving PASI 50, PASI 90, or PASI 100 at each visit.(week 54)
- Change from baseline in the Itch Numerical Rating Scale (Itch-NRS) score (absolute and percentage) at each visit.(week 54)
- Change from baseline in Body Surface Area (BSA) involvement (absolute and percentage) at each visit.(week 54)
- Change from baseline in the Dermatology Life Quality Index (DLQI) at each visit.(week 54)
- Adverse Event (AE)(week 54)
研究者
研究点 (1)
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