A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

February 5, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236805
        • Bozhou People's Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking Union Medical College Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Southwest Hospital, Third Military Medical University (Army Medical University)
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China, 523109
        • Dongguan People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510400
        • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
        • Contact:
      • Jiangmen, Guangdong, China, 529030
        • Jiangmen Central Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Bao Ding NO.1 Central
        • Contact:
      • Cangzhou, Hebei, China, 061000
        • Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
        • Contact:
    • Henan
      • Kaifeng, Henan, China, 475000
        • Kaifeng People's Hospital
        • Contact:
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
      • Luoyang, Henan, China, 471002
        • Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital)
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • The First Affiliated Hospital of Henan University of CM
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital of Central South University
        • Contact:
      • Shaoyang, Hunan, China, 422000
        • The Central Hospital of Shaoyang
        • Contact:
      • Zhuzhou, Hunan, China, 412000
        • ZhuZhou Central Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210001
        • Jiangsu Peopince Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Yancheng, Jiangsu, China, 224000
        • YanCheng NO.1 People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Pingxiang, Jiangxi, China, 337000
        • Pingxiang People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130000
        • Jilin Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • The Second Hospital of Dalian Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
        • Contact:
      • Weifang, Shandong, China, 261000
        • Weifang People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201821
        • Shanghai Tenth People's Hospital
        • Contact:
    • Shanxi
      • Linfen, Shanxi, China, 041099
        • Linfen Central Hospital
    • Sichuan
      • Deyang, Sichuan, China, 618199
        • Deyang People's Hospital
        • Contact:
      • Luzhou, Sichuan, China, 646000
        • Affiliated Hospital of Southwest Medical University
      • Nanchong, Sichuan, China, 637100
        • Hospital of North Sichuan Medical College
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300120
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315010
        • Ningbo Medical Center Li Huili Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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）;
    • 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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQH3906 Capsule 24 mg
Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning Fasting: 3 Capsules of 8 mg TQH3906
Drug: TQH3906 Capsule
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
Experimental: TQH3906 Capsule 16 mg
Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 2 capsules of 8 mg TQH3906
Drug: TQH3906 Capsule
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
Placebo Comparator: TQH3906 Capsule 0 mg
Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 3 placebo capsules of TQH3906
Drug: TQH3906 Placebo Capsule
Placebo without drug substance.
Active Comparator: Tofacitinib Citrate Tablet 5 mg

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.
Drug: Tofacitinib Citrate Tablet 5 mg
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20% Improvement Criteria
Time Frame: Day 1, 15, 29, 57, 85
The proportion of trial participants achieving an ACR20 response at Week 12.
Day 1, 15, 29, 57, 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR20 in the subgroup of trial participants
Time Frame: Day 1, 15, 29, 57, 85
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)
Time Frame: Day 1, 15, 29, 57, 85
ACR50 response rate
Day 1, 15, 29, 57, 85
American College of Rheumatology 70 (ACR70)
Time Frame: Day 1, 15, 29, 57, 85
ACR70 response rate
Day 1, 15, 29, 57, 85
Psoriasis Area and Severity Index (PASI) 75
Time Frame: Day 1, 15, 29, 57, 85
PASI 75 response rate
Day 1, 15, 29, 57, 85
Psoriasis Area and Severity Index 90
Time Frame: Day 1, 15, 29, 57, 85
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)
Time Frame: From the time trial participants sign the informed consent form to 28 days after the last dose
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)
Time Frame: Up to day 85
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)
Time Frame: Up to day 85
Evaluation of the Peak Concentration (Cmax) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration
Up to day 85
Plasma Clearance (CL/F)
Time Frame: Up to day 85
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)
Time Frame: Up to day 85
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)
Time Frame: Up to day 85
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)
Time Frame: Up to day 85
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
Time Frame: Blood samples were collected within 1 hour before dosing at Baseline, Weeks 2, 4, 8, and 12
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQH3906-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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