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

August 31, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236805
        • Recruiting
        • Bozhou People's Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Recruiting
        • Southwest Hospital, Third Military Medical University (Army Medical University)
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China, 523109
        • Recruiting
        • Dongguan People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510400
        • Recruiting
        • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
        • Contact:
      • Jiangmen, Guangdong, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518035
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • Recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Withdrawn
        • The Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • Bao Ding NO.1 Central
        • Contact:
      • Cangzhou, Hebei, China, 061000
        • Recruiting
        • Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine
        • Contact:
    • Henan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Kaifeng People's Hospital
        • Contact:
      • Luoyang, Henan, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Luoyang, Henan, China, 471002
        • Recruiting
        • Luoyang Orthopedic-Traumatological Hospital Of Henan Province(Henan Provincial Orthopedic Hospital)
        • Contact:
      • Puyang, Henan, China, 457001
        • Recruiting
        • Puyang Oilfield General Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Withdrawn
        • The First Affiliated Hospital of Henan University of CM
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Shaoyang, Hunan, China, 422000
        • Withdrawn
        • The Central Hospital of Shaoyang
      • Zhuzhou, Hunan, China, 412000
        • Recruiting
        • ZhuZhou Central Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210001
        • Recruiting
        • Jiangsu Peopince Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Yancheng, Jiangsu, China, 224000
        • Recruiting
        • Yancheng No.1 People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital Of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Pingxiang, Jiangxi, China, 337000
        • Not yet recruiting
        • Pingxiang People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130000
        • Recruiting
        • Jilin Provincial People's Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Withdrawn
        • The Second Hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Weifang, Shandong, China, 261000
        • Recruiting
        • Weifang People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201821
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
    • Shanxi
      • Linfen, Shanxi, China, 041099
        • Recruiting
        • Linfen Central Hospital
        • Contact:
    • Sichuan
      • Deyang, Sichuan, China, 618199
        • Recruiting
        • Deyang People's Hospital
        • Contact:
      • Luzhou, Sichuan, China, 646000
        • Recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
      • Nanchong, Sichuan, China, 637100
        • Recruiting
        • Hospital of North Sichuan Medical College
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300120
        • Recruiting
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Withdrawn
        • Xinjiang Uygur Autonomous Region People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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）;
    • 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TQH3906 Capsule 24 mg
Oral administration daily from Day 1 (D1) to Day 169 (D169) 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 169 (D169) 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;

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.
Drug: TQH3906 Placebo Capsule
Placebo without drug substance.
Active Comparator: Tofacitinib Citrate Tablet 5 mg

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20% Improvement Criteria
Time Frame: Day 1, 15, 29, 57, 85, 113, 141, 169
The proportion of trial participants achieving an ACR20 response at Week 12.
Day 1, 15, 29, 57, 85, 113, 141, 169

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index 90
Time Frame: Day 1, 15, 29, 57, 85
PASI 90 response rate
Day 1, 15, 29, 57, 85
ACR20 in the subgroup of trial participants
Time Frame: Day 1, 15, 29, 57, 85, 113, 141, 169
The proportion of biologic-naive trial participants in the subgroup who achieved ACR20 response.
Day 1, 15, 29, 57, 85, 113, 141, 169
American College of Rheumatology 50 (ACR50)
Time Frame: Day 1, 15, 29, 57, 85, 113, 141, 169
ACR50 response rate
Day 1, 15, 29, 57, 85, 113, 141, 169
American College of Rheumatology 70 (ACR70)
Time Frame: Day 1, 15, 29, 57, 85, 113, 141, 169
ACR70 response rate
Day 1, 15, 29, 57, 85, 113, 141, 169
Psoriasis Area and Severity Index (PASI) 75
Time Frame: Day 1, 15, 29, 57, 85, 113, 141, 169
PASI 75 response rate
Day 1, 15, 29, 57, 85, 113, 141, 169
Time to Peak Concentration (Tmax)
Time Frame: Up to day 169
Evaluation of the Time to Peak Concentration (Tmax) of TQH3906 in participants with Psoriatic Arthritis after oral administration.
Up to day 169
Peak Concentration (Cmax)
Time Frame: Up to day 169
Evaluation of the Peak Concentration (Cmax) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration
Up to day 169
Plasma Clearance (CL/F)
Time Frame: Up to day 169
Evaluation of the Plasma Clearance (CL/F) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Up to day 169
Plasma Elimination Half-Life (t₁/₂)
Time Frame: Up to day 169
Evaluation of the Plasma Elimination Half-Life (t₁/₂) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Up to day 169
Trough Concentration at Steady State (Cmin, ss)
Time Frame: Up to day 169
Evaluation of the Trough Concentration at Steady State (Cmin, ss) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Up to day 169
Degree of Fluctuation (DF)
Time Frame: Up to day 169
Evaluation of the Degree of Fluctuation (DF) of TQH3906 in Participants with Psoriatic Arthritis After Oral Administration.
Up to day 169
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, 12, 16, 20 and 24.
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, 12, 16, 20 and 24.
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, 12, 16, 20 and 24.
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, 12, 16, 20 and 24.
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)
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 and Severity Level 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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