RECRUITING Phase 2 ClinicalTrials.gov

A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. • ClinicalTrials.gov ID: NCT07406035

Registry updated: 2026-09-02

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Description

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.

Interventions

TQH3906 Capsule (Drug)
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
TQH3906 Placebo Capsule (Drug)
Placebo without drug substance.
Tofacitinib Citrate Tablet 5 mg (Drug)
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.

Conditions

Psoriatic Arthritis

Locations

Bozhou People's Hospital — Bozhou, Anhui, China
Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
Southwest Hospital, Third Military Medical University (Army Medical University) — Chongqing, Chongqing Municipality, China
Dongguan People's Hospital — Dongguan, Guangdong, China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine — Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
Jiangmen Central Hospital — Jiangmen, Guangdong, China
Shenzhen Second People's Hospital — Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China
Bao Ding NO.1 Central — Baoding, Hebei, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine — Cangzhou, Hebei, China
Kaifeng People's Hospital — Kaifeng, Henan, China
Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital) — Luoyang, Henan, China
The First Affiliated Hospital of Henan University of science and Technology — Luoyang, Henan, China
Puyang Oilfield General Hospital — Puyang, Henan, China
The First Affiliated Hospital of Henan University of CM — Zhengzhou, Henan, China
Xiangya Hospital of Central South University — Changsha, Hunan, China
The Central Hospital of Shaoyang — Shaoyang, Hunan, China
Zhuzhou Central Hospital — Zhuzhou, Hunan, China
Jiangsu Peopince Hospital — Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
Yancheng No.1 People's Hospital — Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
Pingxiang People's Hospital — Pingxiang, Jiangxi, China
Jilin Provincial People's Hospital — Changchun, Jilin, China
The First Hospital of Jilin University — Changchun, Jilin, China
The second hospital of dalian medical university — Dalian, Liaoning, China
The First Hospital of China Medical University — Shenyang, Liaoning, China
Shandong Provincial Hospital — Jinan, Shandong, China
Weifang People'S Hospital — Weifang, Shandong, China
Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China
Linfen Central Hospital — Linfen, Shanxi, China
Deyang People's Hospital — Deyang, Sichuan, China
Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China
Hospital of North Sichuan Medical College — Nanchong, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region People's Hospital — Ürümqi, Xinjiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Ningbo Medical Center Li HuiLi Hospital — Ningbo, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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