Actively Recruiting
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-08
36
Participants Needed
1
Research Sites
199 weeks
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
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.
CONDITIONS
Official 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 or female aged between 18 and 70 years.
- Male participants weigh at least 50 kg; female participants weigh at least 45 kg.
- Body mass index (BMI) between 19 and 30 kg/m2.
- Clinical diagnosis of gout per 2015 ACR/EULAR criteria, with no acute attack at screening or at least 2 weeks after remission.
- Serum uric acid level at screening of 420 mol/L or higher.
- Serum uric acid level uncontrolled after standard conventional uric acid-lowering treatment, or contraindicated/intolerant to such treatments.
- Willing to stop any uric acid-lowering drugs at least 7 days before starting methotrexate during run-in.
- Able to tolerate prescribed methotrexate dose during run-in period.
- Able to attend and complete study visits on time.
You will not qualify if you...
- Active systemic infection within 2 weeks before enrollment, including those under treatment.
- Chronic or recurrent infections such as pneumonia or bronchitis; severe lung disease or pulmonary insufficiency; pulmonary fibrosis or bronchiectasis.
- Current or active tuberculosis or receiving anti-TB treatment.
- Diagnosis of osteomyelitis.
- Ongoing or long-term immune system modulating drug use, history of transplant requiring immunotherapy, autoimmune or allergic diseases.
- Known allergies or intolerances to recombinant proteins, uricase, pegylated products, methotrexate, fexofenadine, acetaminophen, corticosteroids, or antihistamines.
- Intolerance to all gout attack management treatments including colchicine, NSAIDs, or prednisone.
- Previous treatment with pegyluricase, recombinant uricase, or other pegylated biologics.
- Participation in other drug trials within 4 weeks before methotrexate or during drug elimination phase.
- Chronic liver diseases such as hepatitis, cirrhosis, or alcoholic liver disease.
- Unstable angina, severe arrhythmias, congestive heart failure (NYHA grade 61 II), uncontrolled hypertension, poor diabetic control, acute stroke, severe digestive bleeding, pleural or abdominal effusion.
- History of Lesch-Nyhan or Kelley-Seegmiller syndrome.
- Glucose-6-phosphate dehydrogenase deficiency or low G6PD test values.
- Estimated glomerular filtration rate under 40 mL/min/1.73m2, dialysis, or end-stage renal disease.
- Elevated liver enzymes (ALT, AST) or low albumin at screening.
- Recent use of blood components or growth factors; low white blood cell, hematocrit, or platelet counts.
- Receiving anticoagulant therapy with elevated INR or APTT.
- Recent radiotherapy or history of malignancy within 5 years (except certain skin or cervical cancers).
- Acute illness within 1 month before screening.
- Recent blood donation or transfusion of at least 400 mL within 3 months.
- Positive hepatitis B (except surface antibody), hepatitis C, syphilis, or HIV tests.
- History of drug or substance abuse or positive drug screen.
- Alcohol abuse in past 3 months or positive alcohol breath test.
- Lactating women or those planning pregnancy or sperm/egg donation within 6 months without effective contraception.
- Serious mental illness or cognitive disorders.
- Investigator judgment that participation is inappropriate.
AI-Screening
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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
CONTACT
C
Chaorong Xu, Master
CONTACT
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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