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Acute Gouty ArthritisPhase 2NCT07453004

A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis

A Phase 2 study testing Plonmarlimab and Compound betamethasone in people with Acute Gouty Arthritis, run by TJ Biopharma Co., Ltd. at 30 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multi center,randomized,double-blind,double-dummy,active-controlled study,and planned enrollment of 120-170 subjects,an interim analysis will be conducted after first 60 subjects complete the 72 -hour pain Visual Analogue Scale(VAS) assessment following their initial dose.Based on the analysis result，the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Gouty Arthritis
What is being tested?
Plonmarlimab and Compound betamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
30 sitesChina
Study dates
26 Mar 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects aged ≥18 years, regardless of gender.
  • Subjects are willing to participate in this study and voluntarily sign the informed consent form.
  • Meet the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria.
  • Experienced ≥3 episodes of acute gout flare within the 12 months prior to baseline (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).
  • Subjects have experienced an acute gout flare within 5 days prior to administration of the investigational product (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).
  • Contraindicated, intolerant, or inadequately responsive to colchicine and/or non-steroidal anti-inflammatory drugs (NSAIDs) (determination based on patient history, referral records, etc., will be made by the investigator).
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  • Baseline pain intensity assessment in the most severely affected joint by the subject using a 0-100 mm Visual Analogue Scale (VAS) is ≥50 mm.
  • Subjects may or may not be receiving urate-lowering therapy. If planning to continue urate-lowering therapy during the study, it must have been at a stable dose for ≥2 weeks prior to baseline.
  • Subjects (including their partners) have no pregnancy plans from the screening period until 90 days after dosing and voluntarily agree to use effective contraception.

Who cannot join

  • Secondary gout caused by various etiologies (e.g., gout induced by chemotherapy, judged by the investigator based on the subject's medical history, referral records, etc.).
  • History of hypersensitivity to any component of the investigational product or to similar biological agents.
  • Contraindication to compound betamethasone therapy.
  • Presence of other rheumatic diseases besides gout that may interfere with interpretation of results, including but not limited to rheumatoid arthritis, infectious/suppurative arthritis, traumatic arthritis, etc.
  • Pulmonary diseases including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary alveolar proteinosis, pulmonary granulomatosis, etc., or any underlying pulmonary disease that significantly impairs pulmonary function as assessed by the investigator, making the subject unsuitable for this clinical study.
  • Cardiovascular diseases: history of acute myocardial infarction, unstable angina, severe arrhythmia (multifrequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation) within the past 6 months; New York Heart Association (NYHA) functional Class III-IV (see Appendix 4). Presence of long QT syndrome or QTc interval > 450 msec (male) or > 470 msec (female) during screening.
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  • History of malignancy within the past 5 years (regardless of treatment), except for successfully treated basal cell or squamous cell carcinoma of the skin.
  • Other diseases: subjects with a past and/or current clinically significant, unstable, or uncontrolled acute or chronic disease unrelated to gout (e.g., acute pneumonia, pulmonary hypertension, diabetic ketoacidosis, acute pancreatitis, etc.), or scheduled medical/surgical procedures; or any condition that places the subject at undue risk or impairs the ability to participate voluntarily.
  • Infections: presence of any known acute, chronic, or recurrent active infection during screening (e.g., tuberculosis, syphilis, HIV, HBV, HCV, Pneumocystis jirovecii, CMV, HSV, VZV, atypical mycobacteria, Histoplasma capsulatum, Salmonella infection, genital herpes, osteomyelitis, urinary tract infection, etc.).
  • Abnormal hepatic and renal function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) > 2 × upper limit of normal (ULN); alkaline phosphatase (ALP) or total bilirubin (TBIL) > 1.5 × ULN; creatinine (Cr) or blood urea nitrogen (BUN) > 1.5 × ULN; or eGFR ≤ 60 mL/min/1.73 m² prior to screening (calculated using the MDRD formula, see Appendix 9).
  • Hematological diseases or abnormal routine blood tests: subjects with a past or current hematological disease including but not limited to myelofibrosis, aplastic anemia, leukemia, lymphoma, etc.; hemoglobin < 90 g/L, platelet count < 80×10⁹/L, white blood cell or neutrophil count below the lower limit of normal with clinically significant abnormality judged by the investigator.
  • Planned surgery or any other medical history (e.g., recent sepsis), laboratory abnormality, or other condition judged by the investigator to render the subject ineligible for this study.
  • History of organ transplantation.
  • Pregnant or lactating female subjects.
  • Participation in any interventional clinical trial (including investigational vaccines) or use of an invasive investigational medical device within 3 months prior to enrollment, or current enrollment in another interventional study.
  • Administration of live (attenuated) vaccine within 30 days prior to screening. Inability to receive intramuscular injection (e.g., subjects on anticoagulants, thrombocytopenia, known bleeding disorders such as idiopathic thrombocytopenic purpura).
  • Drug abuse detected by urine drug screening, including morphine, ketamine, tetrahydrocannabinol, methamphetamine, MDMA, cocaine.
  • Alcohol abuse within 3 months prior to screening, defined as alcohol consumption > 14 units per week (1 unit = 17.5 mL or 14 g pure alcohol; 1 unit ≈ 35 mL of 50% spirits or 350 mL of 5% beer), or unwillingness to abstain from alcohol or alcohol-containing products during the trial.
  • Any other condition deemed by the investigator to render the subject unsuitable for this clinical study, including any condition that may increase study-related risk, interfere with evaluation of the investigational product, or confound interpretation of study results.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lina Qin contact

18600672907

lina.qin@tjbio.com

30 sites in 1 country

China30 sites, 30 recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

    Yongjun Mei

    Not yet recruiting

  • Shandong Medical and Pharmaceutical University Hospital

    Binzhou, Shandong

    Xuebin Wang

    Not yet recruiting

  • The People's Hospital of Jilin Province

    Changchun, Jilin

    Guoping Jiang

    Not yet recruiting

  • Chengdu fifth People's Hospital

    Chengdu, Sichuan

    Yong Zhu

    Not yet recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Lin Tang

    Not yet recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi

    Rongping Li

    Not yet recruiting

  • The first affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

    Yuhong Shi

    Not yet recruiting

  • Huzhou Third People's Hospital

    Huzhou, Zhejiang

    Xiaobing Yang

    Not yet recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Mingliang Feng

    Not yet recruiting

  • Jining NO.1 People's Hospital

    Jining, Shandong

    Shujie Li

    Not yet recruiting

  • Hebei Petro China Central Hospital

    Langfang, Hebei

    Wei Gou

    Not yet recruiting

  • Linfen Central Hospital

    Linfen, Shanxi

    Shuhua Qiang

    Not yet recruiting

  • Linyi People Hospital

    Linyi, Shandong

    Li Jiang

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

    Xiaofei Shi

    Not yet recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan

    Jinmei Zou

    Not yet recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Fang Tan

    Not yet recruiting

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Cundong Mi

    Not yet recruiting

  • PingXiang People's Hospital

    Pingxiang, Jiangxi

    Senhua Dai

    Not yet recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Chunde Bao

    Qiong Fu

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Zhanqing Gu

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Liyun Zhang

    Not yet recruiting

  • UnHospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Rong Du

    Not yet recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu

    Fenghong Yuan

    Not yet recruiting

  • The central Hospital of Xiangtan

    Xiangtan, Hunan

    Yong Tan

    Not yet recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

    Hua Wei

    Not yet recruiting

  • The first People's Hospital of Yibin

    Yibin, Sichuan

    Jiangtao Li

    Not yet recruiting

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong

    Hua Zhang

    Not yet recruiting

  • Zhengzhou Central Hospital

    Zhengzhou, Henan

    Lei Yang

    Not yet recruiting

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong

    Yanlin Li

    Not yet recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan

    Zhenhua Wen

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Punarlimab in Subjects With Acute Gouty Arthritis

This is a multi center,randomized,double-blind,double-dummy,active-controlled study,and planned enrollment of 120-170 subjects,an interim analysis will be conducted after first 60 subjects complete the 72 -hour pain Visual Analogue Scale(VAS) assessment following their initial dose.Based on the analysis result，the sample size may be adjusted, and 1or 2 group(s）of the investigational drug will be selected to continue enrollment along with the active comparator group.The goal is to evaluate the efficacy of plonmarlimab in subjects with acute gouty arthristis.

Being tested
Plonmarlimab, Compound betamethasone, Plonmarlimab placebo, Compound betamethasone placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlonmarlimabDrug

    single dose, intravenous infusion

  • Compound betamethasoneDrug

    single dose, intramuscular injection

  • Plonmarlimab placeboDrug

    single dose, intravenous infusion

  • Compound betamethasone placeboDrug

    single dose, intramuscular injection

Study groups in NCT07453004
Study groupRoleWhat they receive
Group1-Plonmarlimab 3mg/kgExperimentalPlonmarlimab 3mg/kg, Single dose, Intravenous infusion
Receives: Drug: Plonmarlimab; Drug: Compound betamethasone placebo
Group2-Plonmarlimab 6mg/kgExperimentalPlonmarlimab 6mg/kg, Single dose, Intravenous infusion
Receives: Drug: Plonmarlimab; Drug: Compound betamethasone placebo
Group3-Compound betamethasoneActive comparatorCompound betamethasone 7 mg, single dose, intramuscular injection
Receives: Drug: Compound betamethasone; Drug: Plonmarlimab placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale(VAS) score

    The change from baseline in the subject's self-assessed Visual Analogue Scale (VAS) score for pain intensity in the most severely affected joint at baseline, assessed at 72 hours after the initial dose.

    Measured: 72 hours after the initial dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start26 Mar 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453004
Sponsor's protocol ID
THZ0103-203
Status last verified
Oct 2026
First submitted
27 Feb 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plonmarlimab and Compound betamethasone in people with Acute Gouty Arthritis, run by TJ Biopharma Co., Ltd. at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lina Qin (18600672907, lina.qin@tjbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale(VAS) score (time frame: 72 hours after the initial dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07453004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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