NCT07406035招募中2 期
A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.46 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2026年7月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 46
- 主要终点
- American College of Rheumatology 20% Improvement Criteria
研究概览
简要总结
This study is a marketing-oriented clinical trial of TQH3906 Capsules. A total of 156 participants are planned to be enrolled, aiming to evaluate the dose-effect relationship of TQH3906 versus placebo in the treatment of active Psoriatic Arthritis (PsA) at Week 12, with the proportion of participants achieving an American College of Rheumatology 20% (ACR20) Improvement Criteria (ACR20) response at Week 12 as the primary endpoint.
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
- •Sign a written Informed Consent Form, which must meet the following requirements
- •Be willing to participate in the study and able to sign the informed consent form;
- •Be willing and able to complete all study-specific procedures and visits;
- •PsA trial participant disease characteristics
- •Aged 18 to 70 years（inclusive）;
- •ii.diagnosed with PsA for at least 3 months prior to screening, and meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening;
- •Active arthritis at screening and at baseline (Day 1);
- •Has failed or was intolerant to at least one prior therapy;
- •If receiving a conventional synthetic Disease-Modifying Antirheumatic Drug (csDMARD), trial participants must be on only one DMARD, which must have been administered for at least 3 months prior to screening, with a stable dose for at least 28 days prior to the first dose;
- •If using NSAIDs, the dose must have been stable for at least 14 days before the first dose;
- •If using oral corticosteroids, the dose must have been stable for at least 14 days before the first dose;
- •Topical treatments for plaque psoriasis must have remained stable for at least 14 days before the first dose;
- •Female participants of child-bearing potential shall agree to use effective contraception during the study and for 30 days following the last dose, and pregnancy tests at the screening and baseline visits shall be negative; male participants shall agree to use effective contraception during the study and for 30 days following the last dose.
排除标准
- •Presence of conditions other than PsA:
- •Presence of non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) at screening or first dose;
- •Presence of any other autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, etc.;
- •Presence of active (i.e., currently symptomatic) fibromyalgia;
- •Other Medical Conditions and Medical History:
- •Trial participants who are pregnant or breastfeeding;
- •Evidence of a serious illness/condition or unstable clinical condition, or localized active infection/infectious disease;
- •Any major surgery performed within 30 days prior to the first dose of study treatment, or any planned surgery during the study;
- •Cancer or a history of cancer or lymphoproliferative disease within the past 5 years;
- •New York Heart Association (NYHA) Class III or IV congestive heart failure, or any recent episode of heart failure resulting in NYHA Class III/IV symptoms; or a history of clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic drug therapy;
- •Uncontrolled hypertension at screening or randomization;
- •History of thrombotic disease within 24 weeks prior to screening; viii. History of acute coronary syndrome and/or any major cerebrovascular disease within 24 weeks prior to screening;
- •Current or recent (within 3 months prior to randomization) gastrointestinal disease that may affect absorption of study treatment, including gastrointestinal surgery;
- •Severe blood loss (> 500 mL) or blood transfusion within 4 weeks prior to randomization;
- •Inability to take oral medication;
- •Inability to undergo venipuncture and/or tolerate venous access;
- •History of substance abuse with inability to abstain or presence of a psychiatric disorder;
- •Any other medical, psychiatric, and/or social reason as determined by medical judgment;
- •Prior and concomitant medications: If the trial participant has a history of biologic use, the exclusion criteria specified in the protocol will apply;
- •Infection-related:
- •Active tuberculosis identified by chest radiography within 6 months prior to screening; trial participants with a negative chest radiography within 3 months prior to screening are eligible if they meet the protocol requirements;
- •Hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) infection; or syphilis infection requiring treatment;
- •Abnormal physical examination or laboratory findings;
- •History of any major drug allergy; known allergy to any excipient of the investigational product;
- •Inability to comply with the trial protocol;
- •History of substance abuse with inability to abstain or presence of a psychiatric disorder;
- •Participation in another clinical trial and use of another investigational drug (other than for psoriatic arthritis) within 4 weeks prior to the first dose, based on the date of discontinuation from the previous trial;
- •Planned or previous allogeneic bone marrow transplantation or solid organ transplantation;
- •Any condition that, in the investigator's judgment, poses a serious risk to the safety of the trial participant or affects the participant's ability to complete the study.
研究组 & 干预措施
Tofacitinib Citrate Tablet 5 mg
Active Comparator
Oral administration daily from Day 1 (D1) to Day 169 (D169):
Morning fasting: 1 tablet of tofacitinib citrate; Administer 1 tablet of Tofacitinib Citrate at bedtime.
干预措施: Tofacitinib Citrate Tablet 5 mg (Drug)
TQH3906 Capsule 0 mg
Placebo Comparator
Oral administration daily from Day 1 (D1) to Day 85 (D85)： Morning fasting: 3 placebo capsules of TQH3906;
Oral administration daily from Day 86(D86) to Day 169 (D169):
Morning fasting: 2 capsules of 8 mg TQH3906 or 3capsules of 8 mg TQH3906.
干预措施: TQH3906 Placebo Capsule (Drug)
TQH3906 Capsule 24 mg
Experimental
Oral administration daily from Day 1 (D1) to Day 169 (D169) Morning Fasting: 3 Capsules of 8 mg TQH3906
干预措施: TQH3906 Capsule (Drug)
TQH3906 Capsule 16 mg
Experimental
Oral administration daily from Day 1 (D1) to Day 169 (D169) Morning fasting: 2 capsules of 8 mg TQH3906
干预措施: TQH3906 Capsule (Drug)
结局指标
主要结局
American College of Rheumatology 20% Improvement Criteria
时间窗: Day 1, 15, 29, 57, 85, 113, 141, 169
The proportion of trial participants achieving an ACR20 response at Week 12.
American College of Rheumatology 20% Improvement Criteria
时间窗: Day 1, 15, 29, 57, 85
The proportion of trial participants achieving an ACR20 response at Week 12.
次要结局
- ACR20 in the subgroup of trial participants(Day 1, 15, 29, 57, 85, 113, 141, 169)
- American College of Rheumatology 50 (ACR50)(Day 1, 15, 29, 57, 85, 113, 141, 169)
- American College of Rheumatology 70 (ACR70)(Day 1, 15, 29, 57, 85, 113, 141, 169)
- Psoriasis Area and Severity Index (PASI) 75(Day 1, 15, 29, 57, 85, 113, 141, 169)
- Time to Peak Concentration (Tmax)(Up to day 169)
- Peak Concentration (Cmax)(Up to day 169)
- Plasma Clearance (CL/F)(Up to day 169)
- Plasma Elimination Half-Life (t₁/₂)(Up to day 169)
- Trough Concentration at Steady State (Cmin, ss)(Up to day 169)
- Degree of Fluctuation (DF)(Up to day 169)
- Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906(Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24.)
- Evaluation of Defensin Levels in Participants with Psoriatic Arthritis Treated with TQH3906(Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24.)
- Numbers of subjects with incidence and Severity Level of adverse Event (AE), serious Adverse Event (SAE), adverse event leading to study discontinuation, adverse event of special interest (AESI)(From the time trial participants sign the informed consent form to 28 days after the last dose)
- ACR20 in the subgroup of trial participants(Day 1, 15, 29, 57, 85)
- American College of Rheumatology 50 (ACR50)(Day 1, 15, 29, 57, 85)
- American College of Rheumatology 70 (ACR70)(Day 1, 15, 29, 57, 85)
- Psoriasis Area and Severity Index (PASI) 75(Day 1, 15, 29, 57, 85)
- Psoriasis Area and Severity Index 90(Day 1, 15, 29, 57, 85)
- Numbers of subjects with incidence of adverse Event (AE), serious Adverse Event (SAE), adverse event leading to study discontinuation, adverse event of special interest (AESI)(From the time trial participants sign the informed consent form to 28 days after the last dose)
- Time to Peak Concentration (Tmax)(Up to day 85)
- Peak Concentration (Cmax)(Up to day 85)
- Plasma Clearance (CL/F)(Up to day 85)
- Plasma Elimination Half-Life (t₁/₂)(Up to day 85)
- Trough Concentration at Steady State (Cmin, ss)(Up to day 85)
- Degree of Fluctuation (DF)(Up to day 85)
- Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906(Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, and 12)
- Evaluation of Defensin Levels in Participants with Psoriatic Arthritis Treated with TQH3906(Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, and 12)
研究者
研究点 (46)
Loading locations...
相似试验
招募中
1 期
Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis PatientsNCT07266116Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.70
招募中
2 期
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainNCT07285018Eli Lilly and Company150
招募中
1 期
Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced CancersNCT07260708Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.42
尚未招募
2 期
A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic DermatitisNCT07344051Qilu Pharmaceutical Co., Ltd.160
招募中
1 期
To Evaluate the Tolerability and Pharmacokinetics of TQB3142 for Injection in Patients With Advanced Malignant TumorsNCT07338838Chia Tai Tianqing Pharmaceutical Group Co., Ltd.66