A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 试验地点
- 21
- 主要终点
- Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
研究概览
简要总结
This study adopted a multicenter, randomized, double-blind, placebo-controlled phase II/III operation seamless adaptive design, aiming to evaluate the efficacy, safety and tolerability of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis. The trial consists of two parts, including the Phase II clinical research stage and the Phase III clinical research stage.
详细描述
In the Phase II clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted, with a planned enrollment of 120 participants. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 1:1:1 ratio to Trial Group 1, Trial Group 2, and the placebo group, with 40 participants in each group.All randomly assigned participants will undergo a 12-week double-blind treatment and continue to be followed up until the 16th week. The study is divided into three phases: the screening period (up to 4 weeks), the treatment period (12 weeks, approximately 85 ± 3 days), and the follow-up period (2 weeks after the last dose).
In the Phase III clinical research stage, a multi-center, randomized, double-blind, placebo-controlled design will be adopted. It is planned to continue enrolling participants in the Phase III study after the completion of the Phase II clinical trial enrollment, based on the Phase II dose groups (or the recommended dose groups determined based on the Phase II study results) and the placebo group. A total of 420 participants are planned to be enrolled. After providing written informed consent and completing all screening evaluations, eligible participants will be randomly assigned in a 2:2:1 ratio to the CMS-D001 tablet 50 mg QD, 100 mg QD, and placebo control groups. Each treatment group will have a maximum of 168 participants (excluding those who switch from the placebo group), and the placebo group will have a maximum of 84 participants.The research was divided into 4 phases, namely the screening phase (up to 4 weeks), the base phase (16 weeks), the expansion phase (36 weeks), and the follow-up phase (4 weeks after the last administration).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years, willing to sign the ICF
- •Diagnosed with plaque psoriasis for at least 6 months prior to screening.
- •At screening and baseline, PASI score ≥ 12 points, BSA ≥ 10%, sPGA ≥ 3
- •Be eligible for phototherapy or systemic therapy.
排除标准
- •Non-plaque psoriasis (ie, guttate, pustular, erythrodermic, or inverse psoriasis) within 3 months prior to baseline.
- •Other skin diseases at screening or baseline Drug-induced psoriasis.
- •History of severe herpes zoster or severe herpes simplex or current herpes simplex/zoster infection.
- •History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.
- •History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.
- •Active infection or acute illness within 7 days prior to the first dose. Chronic or recurrent infectious diseases at screening or baseline that, in the investigator's judgment, may increase safety risks.
- •Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- •History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
- •History of malignant tumour within 5 years before screening.
- •Previous or current autoimmune diseases.
- •Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
- •Allergic to any component of the investigational drug.
研究组 & 干预措施
CMS-D001 50mg
干预措施: CMS-D001 50mg (Drug)
CMS-D001 100mg
干预措施: CMS-D001 100mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Phase Ⅱ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
时间窗: At week 12
Phase Ⅲ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
时间窗: At week 16
Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS)
时间窗: At week 16
次要结局
- PhaseⅡ:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)(At week 2, 4, 8)
- PhaseⅡ:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.(At week 2, 4, 8, 12)
- PhaseⅡ:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100)(At week 2, 4, 8, 12)
- PhaseⅡ:Change and percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score.(At week 2, 4, 8, 12)
- PhaseⅡ:Change and percentage change in affected Body Surface Area (BSA) from baseline(At week 2, 4, 8, 12)
- PhaseⅡ:Change in Dermatology Life Quality Index (DLQI) score from baseline(At week 2, 4, 8, 12)
- Phase Ⅲ:Number of participants achieving at least 75% improvement in PASI (PASI 75)(At weeks 2, 4, 8, 12 and at each visit in the extension period)
- Phase Ⅲ:Number of participants achieving at least 90% or 100% improvement in PASI (PASI 90/100)(At weeks 2, 4, 8, 12, 16 and at each visit in the extension period)
- Phase Ⅲ:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear)(At weeks 2, 4, 8, 12 and at each visit in the extension period)
- Phase Ⅲ:Change and percentage change in PASI score from baseline(At weeks 2, 4, 8, 12, 16 and at each visit in the extension period)
- Phase Ⅲ:Change and percentage change in affected Body Surface Area (BSA) from baseline(At weeks 2, 4, 8, 12, 16 and at each visit in the extension period)
- Phase Ⅲ:Change in Dermatology Life Quality Index (DLQI) score from baseline(At weeks 2, 4, 8, 12, 16 and at each visit in the extension period)