What is peguricase studying for gout?

Peguricase is being studied to evaluate its safety, tolerability, and how it works in the body when combined with methotrexate in patients with gout who have not responded to standard treatments. This trial aims to find the best dose and support future studies. The research is sponsored by the Shanghai Institute Of Biological Products.

Who may be eligible for this gout clinical trial?

Adults aged 18 to 70 years with a clinical diagnosis of gout who have uncontrolled uric acid levels after standard treatment may be eligible. Both males and females can participate, and participants must be able to tolerate methotrexate and attend study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this gout clinical trial?

Study-related care, including the study drug and all visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years - 70Years

All Genders

ID06298071

Phase Ib Study of Peguricase Injection With Methotrexate for Adults 18 to 70 Years Old With Uncontrolled Gout

Led by Shanghai Institute Of Biological Products · Updated on 2026-01-08

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and tolerability of peguricase injections combined with methotrexate in adults with gout who have not responded well to standard uric acid-lowering treatments. This phase Ib trial also aims to understand how the drug behaves in the body and its initial effectiveness to help determine the best dose and treatment plan for future phase II trials. Participants receive peguricase injections in one of three dose groups 4 mg, 8 mg, or 12 mg. Each group starts with a single dose followed by a 5-day safety observation. If no issues arise, participants then receive multiple doses combined with methotrexate, an oral medication at 15 mg. The multi-dose phase begins 2 to 4 weeks after the single dose phase. Each dose group includes 12 participants. Throughout the study, participants will be monitored for adverse and serious adverse events, and blood samples will be taken to measure how the drug is processed by the body. Researchers will track various markers including drug concentration over time and antibody responses for up to 14 weeks after the first dose. Participants must be able to attend all visits and complete assessments on schedule during the study period.

CONDITIONS

Brief Title

A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Willing and able to give informed consent
Male and female aged between 18 and 70 years old
Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19 and 30 kg/m2
Clinical diagnosis of gout meeting 2015 ACR/EULAR criteria, in non-acute attack or at least 2 weeks after remission
Serum uric acid ≥420 μmol/L at screening
Uncontrolled uric acid levels after standard treatment or contraindicated/intolerant to conventional drugs
Willing to stop other uric acid-lowering drugs at least 7 days before methotrexate use during run-in
Able to tolerate the prescribed methotrexate dose during run-in
Able to attend and complete study visits on time

You will not qualify if you...

Active systemic infection within 2 weeks before enrollment
Chronic or recurrent infections such as pneumonia or bronchitis; active or severe lung disease or pulmonary fibrosis
On anti-TB treatment or active tuberculosis
Diagnosis of osteomyelitis
Long-term use of immune-modulating drugs or history of transplant surgery requiring immunotherapy
Known allergy or intolerance to recombinant proteins, uricase, pegylated products, methotrexate, fexofenadine, acetaminophen, corticosteroids, or antihistamines
Intolerance to all gout attack management drugs (must tolerate at least one: Colchicine, NSAIDs, or Prednisone)
Prior treatment with pegyluricase, recombinant uricase, or other pegylated biological products
Participation in another drug trial within 4 weeks before methotrexate or during drug elimination phase
Chronic liver disease such as hepatitis or cirrhosis
Unstable heart conditions, uncontrolled hypertension, poor diabetic control, recent stroke, severe digestive bleeding, pleural or abdominal effusion
History of certain genetic disorders like Lesch-Nyhan syndrome
Glucose-6-phosphate dehydrogenase deficiency or low G6PD test values
Severe kidney disease or dialysis
Abnormal liver enzymes or low albumin at screening
Recent use of blood components or growth factors, low blood cell counts
Receiving anticoagulant therapy with abnormal coagulation tests
Recent radiation therapy or history of cancer within 5 years (except certain skin or cervical cancers)
Acute illness within 1 month before screening
Recent blood donation or transfusion
Positive tests for hepatitis B (except surface antibody), hepatitis C, syphilis, or HIV
History of drug or substance abuse or positive drug screening
Recent alcohol abuse or positive alcohol breath test
Pregnant or lactating women or plans for pregnancy or donation without contraception
Serious mental or psychological disorders or cognitive impairment
Investigator considers participation inappropriate

Research Team

Dandan Chen, Master

Chaorong Xu, Master

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Phase Ib Study of Peguricase Injection With Methotrexate for Adults 18 to 70 Years Old With Uncontrolled Gout

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria