Actively Recruiting
A Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics, and Initial Efficacy of Peguricase for Injection With Methotrexate in Patients With Gout
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-08
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Institute Of Biological Products
Lead Sponsor
T
The First Affiliated Hospital of Bengbu Medical University
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits depending on screening procedures
Duration - At least 1 week
Participants take methotrexate and stop other uric acid-lowering drugs at least 7 days before starting peguricase treatment, to ensure tolerance of methotrexate.
1 visit for methotrexate tolerance assessment
Duration - Approximately 14 weeks after the first dose
Participants receive single and then multiple doses of peguricase injections combined with methotrexate to evaluate safety and efficacy. Single dose is followed by a 5-day safety observation before proceeding to multiple dosing.
Multiple visits including a 5-day safety observation after single dose, followed by additional visits during multi-dose treatment over up to 14 weeks
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Actively Recruiting
Research Team
D
Dandan Chen, Master
C
Chaorong Xu, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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