NCT07758075尚未招募2 期
A Multicenter, Randomized, Double-blind, Dose-parallel-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis Who Have Poor Response to Biological Agents
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The proportion of participants with a sPGA response of 0 or 1 at week 16.
研究概览
简要总结
This study is a randomized, double-blind, multicenter, dose-parallel-controlled phase II clinical trial.
The study consists of three stages: a 4-week screening period, a 52-week treatment period, and a 12-week follow-up period. For the qualified participants screened, using body weight (≥90 kg or < 90 kg) and whether participants had a poor response to IL-12/23p40 inhibitors in the past (yes vs no) as stratification factors, they were randomly assigned to two groups in a 1:1 ratio: Group 1 and Group 2. The evaluation of the primary study endpoint, some secondary study endpoints and some other endpoints was completed at 16 weeks.
Participants who complete the 52nd week assessment will enter a 12-week safe follow-up period until the end of the study.
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
- Triple (Participant, 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
- •Aged ≥ 18 years at the time of signing the informed consent form (ICF), male or female
- •Body mass index was ≥18 kg/m ² at screening
- •A history of plaque psoriasis ≥6 months before randomization, with or without psoriatic arthritis
- •Inadequate response to at least one biologic agent administered at full dose and on a regular schedule prior to screening
- •tParticipants with plaque psoriasis deemed by the investigator suitable for continued biologic therapy
- •Participants voluntarily sign informed consent before the start of any procedures related to the study, able to communicate smoothly with the investigator, understand and comply with the study protocol requirements
排除标准
- •Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline
- •Drug-induced psoriasis
- •Other skin conditions that, in the investigator's opinion, would interfere with psoriasis assessment
- •Concurrent other active autoimmune diseases
- •Prior exposure to drugs targeting the IL-36 receptor
- •Prior exposure to drugs targeting IL-23p19
- •Systemic treatment other than biological agents was received within 4 weeks before baseline
- •Topical treatment for psoriasis was received within two weeks before the baseline
- •Received photochemotherapy within 4 weeks before baseline, or received phototherapy within 2 weeks before baseline
- •Have participated in any clinical study of a drug or medical device within 3 months prior to baseline or within 5 half-lives of the drug
- •The participants had a previous history of lymphocytic hyperplasia
- •Participants had any history of active malignant tumors or malignant tumors within the five years prior to screening
- •Participants with a history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events, or severe bleeding events within 3 months prior to screening were considered unsuitable for clinical research by the researchers
- •There was a history of opportunistic infection or immunodeficiency disease within 6 months prior to screening
- •If there was an active infection within 2 weeks before baseline requiring oral anti-infection treatment, or if there was a severe infection or systemic infection within 4 weeks before baseline requiring intravenous anti-infection treatment or hospitalization due to infection, or other chronic, recurrent, and active infections that the researcher judged as unsuitable for participation in this study
- •There is active tuberculosis or latent tuberculosis infection
- •Positive human immunodeficiency virus antibody (HIV), or positive hepatitis C virus (HCV) antibody test and positive quantitative hepatitis C ribonucleic acid (HCV-RNA) during screening; Or positive for hepatitis B surface antigen (HBsAg)
- •Patients with severe, progressive, uncontrolled cardiovascular and cerebrovascular, liver, kidney, lung, gastrointestinal, hematopoietic system, endocrine, nervous system, mental system, skin and mucous membrane diseases, etc., as well as other conditions that researchers consider unsuitable for participation in this trial
- •The following situations occur in laboratory tests and/or 12-lead electrocardiogram (ECG) during screening:
- •Aspartate aminotransferase (AST) or ALT is three times or more greater than the upper limit of the normal value (ULN).
- •Total bilirubin > 1.5 times ULN; Serum creatinine > 1.5 times ULN; The hemoglobin level was less than 85.0 g/L for male participants and less than 80.0 g/L for female participants.
- •White blood cell count < 3.0 *109/L; Neutrophil count < 1.5 *109/L; Platelet count < 100*109/L; The 12-lead ECG examination indicated clinically significant abnormalities that might affect the safety of the participants, including but not limited to acute myocardial ischemia, myocardial infarction, and severe arrhythmia.
- •Pregnant or lactating female, or testing positive for human chorionic gonadotropin (hCG)
- •Allergic to the investigational drug (including SHR-1139 injection and placebo) or any component in the investigational drug; Or those with a clear history of allergy to monoclonal antibodies or drugs targeting the same action; Or those with a history of severe drug allergies
- •There was a history of alcohol abuse or illegal drug abuse within one year prior to the screening
- •Those who received a live attenuated vaccine within 12 weeks before randomization, or intended to receive a live attenuated vaccine during the study period, or participated in a vaccine clinical trial within 12 weeks before randomization
- •Donate approximately 500 mL of blood within the 8 weeks prior to randomization or have a blood donation plan during the study period
- •Those who have undergone major surgery within 8 weeks prior to screening or have relevant surgical plans during the study period
- •The researchers judged that there were situations that affected the safety and efficacy evaluation of the investigational drug
研究组 & 干预措施
Group 1: Subcutaneous injection of SHR-1139
Experimental
干预措施: SHR-1139 (Drug)
Group 2: Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo
Experimental
干预措施: SHR-1139 and SHR-1139 pleacebo (Drug)
结局指标
主要结局
The proportion of participants with a sPGA response of 0 or 1 at week 16.
时间窗: at week 16
次要结局
- The proportion of participants whose PASI score improved by at least 100% compared to the baseline in week 16 (reaching PASI 100)(week 16)
- The proportion of participants with a 0 sPGA response in week 16(week 16)
- The proportion of participants with a sPGA response of 0 or 1 at all other visits every four weeks, up to 64 weeks(up to 64 weeks)
- The proportion of participants whose PASI score improved by at least 90% compared to the baseline in week 16 (reaching PASI 90)(week 16)
- The proportion of participants whose PASI score improved by at least 75% compared to the baseline in week 16 (reaching PASI 75)(week 16)
- The proportion of participants reaching PASI 90 at all other visits every four weeks, up to 64 weeks(up to 64 weeks)
- The proportion of participants reaching PASI 75 at all other visits every four weeks, up to 64 weeks(up to 64 weeks)
- The proportion of participants reaching PASI 100 at all other visits every four weeks, up to 64 weeks(up to 64 weeks)
- The proportion of participants with a sPGA response of 0 at all other visits every four weeks, up to 64 weeks(up to 64 weeks)
- The change values and percentage of change in PASI scores at each visiting point every four weeks relative to the baseline, up to 64 weeks(up to 64 weeks)
- Among the participants with a baseline pruritus score (NRS) of ≥4, the proportion of those with an improvement of ≥4 at week 16(week 16)
- The proportion of participants who achieved a dermatological quality of life index (DLQI) of 0 or 1 at week 16(week 16)
- The change in NRS scores at each visit point every four weeks relative to the baseline and the percentage of change, up to 64 weeks(up to 64 weeks)
- The change values and percentage changes of DLQI scores at each visiting point every four weeks relative to the baseline, up to 64 weeks(up to 64 weeks)
- The time from randomization to 16 weeks when the sPGA response first reached 0 or 1(16 weeks)
- The time from randomization to 16 weeks when the sPGA response first reached 0(16 weeks)
- The time when participants first reached PASI 75 from randomization to 16 weeks(16 weeks)
- The time when participants first reached PASI 90 from randomization to 16 weeks(16 weeks)
- The proportion of participants who achieved an sPGA response of 0 or 1 in week 16 and still achieved an sPGA response of 0 or 1 in week 26(week 26)
- The proportion of participants who achieved PASI 75 in week 16 and still reached PASI 75 in Week 26(Week 26)
- The proportion of participants who achieved PASI 90 in week 16 and still reached PASI 90 in week 26(week 26)
- The proportion of participants who achieved an sPGA response of 0 or 1 in week 16 and still achieved an sPGA response of 0 or 1 in week 52(week 52)
- The proportion of participants who achieved PASI 75 in week 16 and still reached it in Week 52(Week 52)
- The proportion of participants who achieved PASI 90 in week 16 and still reached it in week 52(week 52)
- The proportion of participants who achieved an sPGA response of 0 or 1 in week 26 and still achieved an sPGA response of 0 or 1 in week 52(week 52)
- The proportion of participants who achieved PASI 75 in week 26 and still reached it in Week 52(Week 52)
- The proportion of participants who achieved PASI 90 in week 26 and still reached it in week 52(week 52)
- Safety and tolerability: Adverse events, up to 68 weeks(up to 68 weeks)
- PK: The concentration of SHR-1139 in serum at week0,1,4,8,16,26,28,44,64(at week0,1,4,8,16,26,28,44,64)
- Immunogenicity: The positive incidence rate of ADA at week 0,8,16,26,44,64(at week 0,8,16,26,44,64)
- Immunogenicity: The positive occurrence time of ADA at week 0,8,16,26,44,64(at week 0,8,16,26,44,64)
- Biomarker: Inhibition rate of IFNγ activation and release in whole blood at each time point after administration at week0,1,4,8,16,26,28,44,64(at week0,1,4,8,16,26,28,44,64)
研究者
研究点 (1)
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