Psoriatic ArthritisPhase 2NCT07406035
A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
A Phase 2 study testing TQH3906 Capsule and Tofacitinib Citrate Tablet 5 mg in people with Psoriatic Arthritis, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 44 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- TQH3906 Capsule and Tofacitinib Citrate Tablet 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 44 sitesChina
- Study dates
- 16 Jul 2026to Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Other:
- 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.
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
China44 sites, 39 recruiting
- Recruiting
Bao Ding NO.1 Central
Baoding, Hebei, 071000
Junqiao Li, Bachelor, 18617789105, bdyzxljq@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Xiaofeng Zeng, Doctor, 13501069845, xiaofeng.zeng@cstar.org.cn
- Recruiting
Bozhou People's Hospital
Bozhou, Anhui, 236805
Yuhui Zhang, Doctor, 18905688161, clearhui1118@126.com
- Recruiting
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
Cangzhou, Hebei, 061000
Weiwei Lu, Master, 18031783702, 11070307@qq.com
- Recruiting
Jilin Provincial People's Hospital
Changchun, Jilin, 130000
GUOPING JIANG, Master, 13756113726, jianggp0808@163.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Zhenyv Jiang, Doctor, 15843079623, jzyd0197@163.com
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Juan Su, Doctor, 15116408921, 3694944834@qq.com
- Recruiting
Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, 400038
Bing Zhong, Master, 18203063388, dune_zhong@163.com,
- Withdrawn
The second hospital of dalian medical university
Dalian, Liaoning, 116000
- Recruiting
Deyang People's Hospital
Deyang, Sichuan, 618199
Lin Feng, Bachelor, 13708103308, 18090757371@163.com
- Recruiting
Dongguan People's Hospital
Dongguan, Guangdong, 523109
Guangming Han, Doctor, 13533391069, ghan54321@163.com
- Recruiting
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, 510400
Changsong Lin, Master, 13802772276, 13802772276@163.com
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Yunfeng Pan, Doctor, 18922102921, panyunfeng@medmail.com.cn
- Withdrawn
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yongmei Han, Master, 15057155500, yujiangnan58@163.com
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jin Lin, Doctor, 13906539996, linjinzju@163.com
- Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030
Chujun Ouyang, Doctor, 13630480333, chelly1122@126.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Hongsheng Sun, Master, 15168888385, 13869192509@126.com
- Recruiting
Kaifeng People's Hospital
Kaifeng, Henan, 475000
Zhexin Wang, Bachelor, 13949401020, kfwzx1020@163.com
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 041099
Shuhua Qiang, Bachelor, 18636785653, qsh18636785653@126.com
- Recruiting
Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital)
Luoyang, Henan, 471002
Hongli Hou, Master, 13838861918, beckhansome@163.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471003
Xiaofei Shi, Master, 13663884080, sxf64817332@163.com
- Recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
ChengSong He, Master, 13700980878, 13700980878@163.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Rui Wu, Doctor, 13970997559, 13970997559@139.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xinwang Duan, Doctor, 13970085678, 13970085678@163.com
- Recruiting
Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637100
Yufeng Qing, Doctor, 15882657267, qingyufengqq@163.com
- Recruiting
Jiangsu Peopince Hospital
Nanjing, Jiangsu, 210001
WenFeng TAN, Postdoctoral, 13770769608, Tanwenfeng@gmail.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Lingyun Sun, Doctor, 13705186409, lingyunsun2012@163.com
- Recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
CunDong Mi, Master, 15807801372, Md-392@126.com
- Recruiting
Ningbo Medical Center Li HuiLi Hospital
Ningbo, Zhejiang, 315010
Jin Zhang, Master, 13486089482, 751860714@qq.com
- Not yet recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000
Senhua Dai, Master, 159 7922 2982, 15979222982@163.com
- Recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Fengju Li, Bachelor, 13030300169, 13030300169@163.com
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 201821
Xinying Liu, Doctor, 18917684056, liuxinying@tongji.edu.cn
- Withdrawn
The Central Hospital of Shaoyang
Shaoyang, Hunan, 422000
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Hui Shen, Doctor, 13898897439, shenhuicam@souhu.com
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Meiying Wang, Doctor, 13723769919, wmy99wmy99@163.com
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Zhichun Liu, Doctor, 13771994276, lzchun5190@sina.com
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Litao Zhang, Doctor, 18602228122, ZhanglitaoYG@163.com
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120
Weifeng Yao, Doctor, 15620250048, weifeng96033@163.com
- Withdrawn
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830001
- Recruiting
Weifang People'S Hospital
Weifang, Shandong, 261000
Jingjing Ma, Master, 13626469450, wfmjj001@163.com
- Recruiting
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, 224000
Xiangdong Ren, Bachelor, 13770070889, rxd_2025@qq.com
- Withdrawn
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, 450003
- Recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000
Zhenhua Wen, Master, 13387411981, 151728544@qq.com
About this study
Official title: 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
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.
- Conditions
- Psoriatic Arthritis
- Being tested
- TQH3906 Capsule, TQH3906 Placebo Capsule, Tofacitinib Citrate Tablet 5 mg
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH3906 CapsuleDrug
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
TQH3906 Placebo CapsuleDrug
Placebo without drug substance.
Tofacitinib Citrate Tablet 5 mgDrug
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| TQH3906 Capsule 24 mg | Experimental | Oral administration daily from Day 1 (D1) to Day 169 (D169) Morning Fasting: 3 Capsules of 8 mg TQH3906 Receives: Drug: TQH3906 Capsule |
| TQH3906 Capsule 16 mg | Experimental | Oral administration daily from Day 1 (D1) to Day 169 (D169) Morning fasting: 2 capsules of 8 mg TQH3906 Receives: Drug: TQH3906 Capsule |
| 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. Receives: Drug: TQH3906 Placebo Capsule |
| 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. Receives: Drug: Tofacitinib Citrate Tablet 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20% Improvement Criteria
The proportion of trial participants achieving an ACR20 response at Week 12.
Measured: Day 1, 15, 29, 57, 85, 113, 141, 169
Secondary outcomes (14)
ACR20 in the subgroup of trial participants
The proportion of biologic-naive trial participants in the subgroup who achieved ACR20 response.
Measured: Day 1, 15, 29, 57, 85, 113, 141, 169
American College of Rheumatology 50 (ACR50)
ACR50 response rate
Measured: Day 1, 15, 29, 57, 85, 113, 141, 169
American College of Rheumatology 70 (ACR70)
ACR70 response rate
Measured: Day 1, 15, 29, 57, 85, 113, 141, 169
Psoriasis Area and Severity Index (PASI) 75
PASI 75 response rate
Measured: Day 1, 15, 29, 57, 85, 113, 141, 169
Psoriasis Area and Severity Index 90
PASI 90 response rate
Measured: Day 1, 15, 29, 57, 85
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)
Numbers of subjects with incidence rates and Severity Level of Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events Leading to Study Discontinuation, and Adverse Events of Special Interest (AESIs)
Measured: 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.
Measured: Up to day 169
Peak Concentration (Cmax)
Evaluation of the Peak Concentration (Cmax) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration
Measured: Up to day 169
Plasma Clearance (CL/F)
Evaluation of the Plasma Clearance (CL/F) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Measured: Up to day 169
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.
Measured: Up to day 169
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.
Measured: Up to day 169
Degree of Fluctuation (DF)
Evaluation of the Degree of Fluctuation (DF) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Measured: Up to day 169
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
Measured: 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
Evaluation of Defensin Levels in Participants with Psoriatic Arthritis Treated with TQH3906
Measured: Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start16 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406035
- Sponsor's protocol ID
- TQH3906-II-02
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No