A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
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
1 other identifier
interventional
156
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2026
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedStudy Start
First participant enrolled
July 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
July 24, 2026
July 1, 2026
1 year
January 29, 2026
July 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Study Arms (4)
TQH3906 Capsule 24 mg
EXPERIMENTALOral administration daily from Day 1 (D1) to Day 85 (D85) Morning Fasting: 3 Capsules of 8 mg TQH3906
TQH3906 Capsule 16 mg
EXPERIMENTALOral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 2 capsules of 8 mg TQH3906
TQH3906 Capsule 0 mg
PLACEBO COMPARATOROral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 3 placebo capsules of TQH3906
Tofacitinib Citrate Tablet 5 mg
ACTIVE COMPARATOROral 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.
Interventions
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
Eligibility Criteria
You may qualify if:
- 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）;
- BMI ≥ 18 kg/m² at screening; 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;
- 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
You may not qualify if:
- 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;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Bozhou People's Hospital
Bozhou, Anhui, 236805, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, 400038, China
Dongguan People's Hospital
Dongguan, Guangdong, 523109, China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, 510400, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Bao Ding NO.1 Central
Baoding, Hebei, 071000, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
Cangzhou, Hebei, 061000, China
Kaifeng People's Hospital
Kaifeng, Henan, 475000, China
Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital)
Luoyang, Henan, 471002, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471003, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, 450003, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Central Hospital of Shaoyang
Shaoyang, Hunan, 422000, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000, China
Jiangsu Peopince Hospital
Nanjing, Jiangsu, 210001, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, 224000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
Jilin Provincial People's Hospital
Changchun, Jilin, 130000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The second hospital of dalian medical university
Dalian, Liaoning, 116000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Weifang People'S Hospital
Weifang, Shandong, 261000, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 201821, China
Linfen Central Hospital
Linfen, Shanxi, 041099, China
Deyang People's Hospital
Deyang, Sichuan, 618199, China
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
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830001, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Ningbo Medical Center Li HuiLi Hospital
Ningbo, Zhejiang, 315010, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2026
First Posted
February 12, 2026
Study Start
July 16, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
July 24, 2026
Record last verified: 2026-07