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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQH3906 Capsule 24 mg | Experimental | Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning Fasting: 3 Capsules of 8 mg TQH3906 |
|
| TQH3906 Capsule 16 mg | Experimental | Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 2 capsules of 8 mg TQH3906 |
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| TQH3906 Capsule 0 mg | Placebo Comparator | Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 3 placebo capsules of TQH3906 |
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| Tofacitinib Citrate Tablet 5 mg | Active Comparator | Oral administration daily from Day 1 (D1) to Day 85 (D85): Morning fasting: 1 tablet of tofacitinib citrate Administer 1 tablet of Tofacitinib Citrate at bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQH3906 Capsule | Drug | TQH3906 is a small-molecule inhibitor of tyrosine kinase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 20% Improvement Criteria | The proportion of trial participants achieving an ACR20 response at Week 12. | Day 1, 15, 29, 57, 85 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 in the subgroup of trial participants | The proportion of biologic-naive trial participants in the subgroup who achieved ACR20 response at Week 12. | Day 1, 15, 29, 57, 85 |
| American College of Rheumatology 50 (ACR50) |
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Inclusion Criteria:
Sign a written Informed Consent Form, which must meet the following requirements
PsA trial participant disease characteristics
Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of the study; men must agree to use effective contraception during the study and for 6 months after the end of the study
Exclusion Criteria:
Presence of conditions other than PsA:
Other Medical Conditions and Medical History:
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:
Abnormal physical examination or laboratory findings;
Other:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofeng Zeng, Doctor | Contact | 13501069845 | xiaofeng.zeng@cstar.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bozhou People's Hospital | Bozhou | Anhui | 236805 | China |
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| TQH3906 Placebo Capsule | Drug | Placebo without drug substance. |
|
| Tofacitinib Citrate Tablet 5 mg | Drug | Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors. |
|
ACR50 response rate
| Day 1, 15, 29, 57, 85 |
| American College of Rheumatology 70 (ACR70) | ACR70 response rate | Day 1, 15, 29, 57, 85 |
| Psoriasis Area and Severity Index (PASI) 75 | PASI 75 response rate | Day 1, 15, 29, 57, 85 |
| Psoriasis Area and Severity Index 90 | PASI 90 response rate | 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) | Numbers of subjects with incidence rates of Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events Leading to Study Discontinuation, and Adverse Events of Special Interest (AESIs) | From the time trial participants sign the informed consent form to 28 days after the last dose |
| Time to Peak Concentration (Tmax) | Evaluation of the Time to Peak Concentration (Tmax) of TQH3906 in participants with Psoriatic Arthritis after oral administration. | Up to day 85 |
| Peak Concentration (Cmax) | Evaluation of the Peak Concentration (Cmax) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration | Up to day 85 |
| Plasma Clearance (CL/F) | Evaluation of the Plasma Clearance (CL/F) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. | Up to day 85 |
| Plasma Elimination Half-Life (t₁/₂) | Evaluation of the Plasma Elimination Half-Life (t₁/₂) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. | Up to day 85 |
| Trough Concentration at Steady State (Cmin, ss) | Evaluation of the Trough Concentration at Steady State (Cmin, ss) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. | Up to day 85 |
| Degree of Fluctuation (DF) | Evaluation of the Degree of Fluctuation (DF) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration. | Up to day 85 |
| Evaluation of Interleukin (IL) Levels in Participants with Psoriatic Arthritis Treated with TQH3906 | 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 | 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 |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
| Southwest Hospital, Third Military Medical University (Army Medical University) | Chongqing | Chongqing Municipality | 400038 | China |
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| Dongguan People's Hospital | Dongguan | Guangdong | 523109 | China |
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| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | Guangzhou | Guangdong | 510400 | China |
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| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
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| Jiangmen Central Hospital | Jiangmen | Guangdong | 529030 | China |
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| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 518035 | China |
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| The Second Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530007 | China |
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| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550004 | China |
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| Bao Ding NO.1 Central | Baoding | Hebei | 071000 | China |
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| Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine | Cangzhou | Hebei | 061000 | China |
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| Kaifeng People's Hospital | Kaifeng | Henan | 475000 | China |
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| Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital) | Luoyang | Henan | 471002 | China |
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| The First Affiliated Hospital of Henan University of science and Technology | Luoyang | Henan | 471003 | China |
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| The First Affiliated Hospital of Henan University of CM | Zhengzhou | Henan | 450003 | China |
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| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
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| The Central Hospital of Shaoyang | Shaoyang | Hunan | 422000 | China |
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| Zhuzhou Central Hospital | Zhuzhou | Hunan | 412000 | China |
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| Jiangsu Peopince Hospital | Nanjing | Jiangsu | 210001 | China |
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| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
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| Yancheng No.1 People's Hospital | Yancheng | Jiangsu | 224000 | China |
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| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| Pingxiang People's Hospital | Pingxiang | Jiangxi | 337000 | China |
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| Jilin Provincial People's Hospital | Changchun | Jilin | 130000 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| The second hospital of dalian medical university | Dalian | Liaoning | 116000 | China |
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| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
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| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
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| Weifang People'S Hospital | Weifang | Shandong | 261000 | China |
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| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 201821 | China |
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| Linfen Central Hospital | Linfen | Shanxi | 041099 | China |
| Deyang People's Hospital | Deyang | Sichuan | 618199 | China |
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| Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | 646000 | China |
| Hospital of North Sichuan Medical College | Nanchong | Sichuan | 637100 | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | 300120 | China |
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| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | 300120 | China |
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| Xinjiang Uygur Autonomous Region People's Hospital | Ürümqi | Xinjiang | 830001 | China |
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| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
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| Ningbo Medical Center Li HuiLi Hospital | Ningbo | Zhejiang | 315010 | China |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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