NCT06542614已完成2 期
A Phase II Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamic (PD) Profile of TQH3906 in Subjects With Moderate to Severe Plaque Psoriasis
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.35 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2024年8月27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
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 35
- 主要终点
- Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12
研究概览
简要总结
To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18-70 years old (both 18 and 70 years old), regardless of gender；
- •Clinically diagnosed with stable moderate to severe plaque psoriasis with a history ≥ 6 months (from randomization), and no morphological changes in skin lesions or significant disease outbreaks as assessed by the investigator;
- •Appropriate for systemic therapy or phototherapy as judged by the investigator;
- •At screening and baseline, the PASI score was ≥ 12 points, the BSA ≥ 10%, and the sPGA ≥ 3 points ;
- •Have a full understanding of this study, voluntarily participate in the trial, and have signed a written informed consent form;
- •Subjects (including partners) are willing to voluntarily use appropriate and effective contraceptive measures from screening to 3 months after the last dose of study drug.
排除标准
- •Pregnant and lactating females;
- •Have other forms of psoriasis other than plaque psoriasis (e.g., guttate psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, arthropathic psoriasis);
- •Presence of serovirological abnormalities during the screening period:
- •Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcA positive and Hepatitis B virus (HBV) DNA positive, or Hepatitis C virus (HCV) antibody positive and HCV-RNA positive;
- •Positive for HIV antibody during the screening period, or have a history of HIV infection in the past;
- •Positive Treponema pallidum antibody and positive non-Treponema pallidum serum test (RPR or TRUST) during the screening period;
- •Have a history of active tuberculosis during the screening period or before, or have latent tuberculosis infection found at screening (refers to T-SPOT positive without clinical manifestations). (Note: Patients with latent tuberculosis infection can be re-screened 1 month after starting prophylaxis according to the guidelines, and in order to continue to participate in the study, patients must agree to continue to complete the prophylactic regimen during the study, but rifampicin treatment should be avoided.) ;
- •Has a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, generalized herpes zoster;
- •History of severe bacterial, fungal or viral infection within 2 months prior to randomization, requiring hospitalization for intravenous antibiotics or antiviral drug treatment;
- •Live vaccine within 4 weeks prior to randomization or planned live vaccine during the study;
- •Clinically significant infection, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, during the screening period, and requiring antibiotic or antiviral medication treatment;
- •Has any significant illness or unstable clinical condition (such as renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurological, immune, or locally active infectious/infectious disease) that is judged by the investigator to be unsuitable for participation in this study.
- •Abnormal laboratory tests during the screening period:
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times upper limit of normal (ULN);
- •Hemoglobin <90g/L;
- •White blood cell count< 3.0×109/L;
- •Neutrophil count<1.0×109/L;
- •Lymphocyte count<0.5×109/L;
- •Platelet count < 100×109/L;
- •Total bilirubin >2 times ULN;
- •Other significant laboratory test abnormalities that, in the opinion of the investigator, the subject is not suitable for participation in this study.
- •History of malignant tumors (including carcinoma in situ) and lymphoproliferative disorders within 5 years prior to randomization;
- •Those who have received at least 6 consecutive months of anti-IL-12, IL-17, IL23 monoclonal antibody drugs (such as ustekin, secukziu, ichizzo, gusechiu, etc.) at the approved dose but have poor clinical response (defined as not achieving PASI 50 during treatment)；
- •Receipt of any other marketed or investigational biologic agent within 3 months or 5 half-lives (whichever is longer) prior to randomization;
- •Receipt of any other investigational drug in 1 month or 5 half-lives (whichever is longer) prior to randomization;
- •Those who have undergone surgical surgery within 4 weeks prior to randomization, or who plan to undergo surgical procedures during the study;
- •Those who have lost blood or donated more than 400 mL of blood within 4 weeks prior to randomization;
- •Receipt of immunoglobulin or blood products within 4 weeks prior to randomization;
- •Systemic treatment drugs or immunosuppressants for psoriasis within 4 weeks prior to randomization, including but not limited to retinoids, glucocorticoids, methotrexate, cyclosporine, azathioprine, Janus kinase (JAK) inhibitors, etc;
- •Use of strong CYP450 inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin, etc.) within 4 weeks prior to randomization;
- •Received topical or systemic phototherapy within 4 weeks prior to randomization, including but not limited to Narrow-band ultraviolet B (NB-UVB), photochemotherapy (PUVA), 308nm excimer light;
- •Use of topical drugs that may affect the severity of skin lesions in psoriasis within 2 weeks prior to randomization, including but not limited to glucocorticoids, urea, >3% salicylic acid, α or β hydroxy acids, retinoids, vitamin D3 analogues, calcineurin inhibitors, Phosphodiesterase-4 (PDE-4) inhibitors, etc. (Note: Mild emollients (without active substances such as urea, salicylic acid, α, or β hydroxy acids) are allowed to be used at all sites, but should not be used within 24 hours prior to each study visit);
- •Potential difficulty in blood collection, with a history of fainting needle and blood sickness;
- •Allergy to any of the known ingredients of the TQH3906, or any previous history of severe drug allergies.
- •Those with a history of substance abuse;
- •Has any other reasonable medical, psychiatric, or social reason that, in the opinion of the investigator, precludes participation in this study.
研究组 & 干预措施
TQH3906 capsules
Experimental
TQH3906 capsules are administered orally at the same time (±2 hours) on an empty stomach every day for 12 weeks starting from Day 1.
干预措施: TQH3906 capsules (Drug)
Placebo of TQH3906 capsules
Placebo Comparator
TQH3906 capsules placebo: TQH3906 capsules placebo administered orally once daily for 12 weeks at the same time (±2 hours) on an empty stomach starting from Day 1.
干预措施: Placebo of TQH3906 capsules (Drug)
结局指标
主要结局
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 at week 12
时间窗: Up to week 12
Achieve a PASI 75 ratio
次要结局
- Proportion of patients achieving Static Physician's Global Assessment (sPGA) 0/1 at week 12(Up to week 12)
- Proportion of patients achieving PASI 50 at week 12(Up to week 12)
- Proportion of patients achieving PASI 90 at week 12(Up to week 12)
- Proportion of patients achieving PASI 100 at week 12(Up to week 12)
- Body Surface Area (BSA) score(Up to week 12)
- Dermatology Life Quality Index (DLQI) score(Up to week 12)
- Incidence of abnormal laboratory test markers(From randomization to 4 weeks after the last dose)
- Adverse event (AE)(From randomization to 4 weeks after the last dose)
- Serious Adverse Events (SAEs)(From randomization to 4 weeks after the last dose.)
- Tmax, ss(Within 1 hour before Day1, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day 15, Day 29, Day 57, Day 85 within 1 hour before administration, 1,1.5, 2, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours after Day 85)
- Cmax, ss(Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72 hours after Day85)
- Cmin, ss(Within 1 hour before Day1, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85)
- Area under the plasma concentration-time curve (AUC) 0-τ(Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85)
- Rac(Within 1 hour before Day1 administration, 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours, Day15, Day29, Day57, Day85 within 1 hour before administration, and 1 hour, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours after Day85)
- Interleukin-17A (IL-17A) in serum(Within 1 hour before Day1 administration, Day15, Day29, Day85)
- Interleukin 19 (IL-19) in serum(Within 1 hour before Day1 administration, Day15, Day29, Day85)
- β defensin in serum(Within 1 hour before Day1 administration, Day15, Day29, Day85)
研究者
研究点 (35)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque PsoriasisPsoriasis VulgarisNCT01072383Biotest49
已完成
3 期
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or IxekizumabPlaque PsoriasisNCT04102007AbbVie244
已完成
2 期
Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type PsoriasisPsoriasisNCT00606450Amgen260
未知
2 期
M518101 phase 2b study in plaque psoriasis patients - comparison study 2Plaque psoriasisJPRN-jRCT2080221434Maruho Co.,Ltd.
未知
2 期
M518101 phase 2b study in plaque psoriasis patients - comparison study 1Plaque psoriasisJPRN-jRCT2080221433Maruho Co.,Ltd.