Phase 1 Gout Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to give informed consent to participate.
• Men and women between 18 and 70 years old.
• Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (BMI) between 19 and 30.
• People with a confirmed gout diagnosis (based on 2015 international rheumatology guidelines), whose gout is not currently in a flare-up — or who have been fully recovered from a flare-up for at least 2 weeks — and whose blood uric acid level is at or above a certain threshold at screening.
• People whose uric acid levels have not reached the target with standard uric acid-lowering medicines, or who are unable to take those medicines due to medical reasons or side effects.
• People who are willing to stop taking uric acid-lowering medicines for at least 7 days before the start of a lead-in phase involving a medicine called methotrexate.
• People who are able to tolerate the required dose of methotrexate during the lead-in period.
• People who are able to attend all scheduled appointments and complete the study visits on time.

Who may not be able to join:

• People who have had an active infection in the 2 weeks before enrolment, including infections currently being treated.
• People with a history of repeated or long-lasting infections, such as recurring pneumonia or chronic bronchitis, or who have active or serious lung disease, pulmonary fibrosis, or bronchiectasis shown on chest imaging.
• People currently being treated for tuberculosis (TB), or who have active TB.
• People with a diagnosis of bone infection (osteomyelitis).
• People who are currently using, or have used long-term, medicines that affect the immune system — such as methotrexate, mercaptopurine, mycophenolate, or corticosteroids (e.g. prednisone at or above a certain dose for 3 months or more) — or who have had an organ transplant requiring ongoing immune-suppressing medicine, or who have a known autoimmune or allergic disease.
• People with a known allergy to products made from recombinant proteins or pork-derived materials, or a history of allergy to uricase, pegylated products, corticosteroids, or antihistamines, or known intolerance or medical contraindication to methotrexate, fexofenadine, or acetaminophen (paracetamol).
• People who cannot tolerate any of the standard medicines used to manage gout flare-ups — at least one of colchicine, anti-inflammatory pain medicines (NSAIDs), or low-dose prednisone must be tolerable.
• People who have previously been treated with pegloticase or any other recombinant uricase, or with other pegylated biological medicines.
• People who have taken part in another clinical drug trial within 4 weeks before the start of the lead-in period, or for whom the previous trial medicine has not yet cleared from their body.
• People with chronic liver conditions such as hepatitis, cirrhosis, or alcoholic liver disease.
• People with certain serious heart or circulatory conditions, including unstable chest pain, severe heart rhythm problems, heart failure (of a certain severity), poorly controlled high blood pressure (above 150/95 mmHg), poorly controlled diabetes (HbA1c at or above 7%), recent stroke, serious or ongoing digestive bleeding, or fluid build-up around the lungs or in the abdomen.
• People with a history of a rare inherited condition affecting how the body processes uric acid, such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.
• People with a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (G6PD), or whose G6PD test result is below the normal range.
• People whose kidney function is significantly reduced (eGFR at or below 40 mL/min/1.73m²), who are currently on dialysis, or who have advanced chronic kidney disease (stage 4 or 5).
• People whose liver enzyme levels (ALT or AST) are above the normal range, or whose albumin (a blood protein) is below the normal range at screening.
• People who have received blood products or certain blood cell growth medicines within 14 days before screening, or whose blood counts fall below certain thresholds.
• People who are taking blood-thinning (anticoagulant) medicines, or whose blood clotting test results are above a certain level before enrolment.
• People who have received radiotherapy for cancer, or who have been diagnosed with cancer in the past 5 years (with certain exceptions such as some early-stage skin cancers).
• People who have had any significant acute illness within 1 month before screening that the trial team considers likely to affect the study.
• People who have donated or lost 400 mL or more of blood, or who have received a blood transfusion, within 3 months before screening.
• People who test positive for hepatitis B (other than the surface antibody), hepatitis C, syphilis, or HIV.
• People with a history of drug or substance misuse, or who test positive on a drug screening test.
• People who have drunk more than 14 units of alcohol per week in the 3 months before screening, or who test positive on a breathalyser test at admission.
• Women who are breastfeeding, or people (and their partners) who are planning a pregnancy or planning to donate sperm or eggs within 6 months of the study, who are unwilling to use effective contraception from 30 days before the study through to the end of the study.
• People with serious mental health conditions, cognitive difficulties, or a history of psychiatric illness.
• People whom the trial investigators consider unsuitable for the study for any other reason.

Important: Always verify eligibility with the trial site directly before applying.