Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

Completed · Phase 2

Conditions studied: Gout

In brief

The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level \<6 mg/dL, in patients with chronic, refractory gout.

Key facts

Study ID

NCT02598596

Run by

Ampel BioSolutions, LLC

People needed

132

Starts

2015-12-01

Expected to finish

2020-04-27

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (age ≥18 years) men and women of non-childbearing potential, with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated.
• Hyperuricemic - Screening visit SUA must be >6 mg/dL
• On gout flare prophylactic regimen for 7 days prior to the first dose.
• Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed)

You may not qualify if…

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (confirmed at Screening visit)
• Non-compensated congestive heart failure, uncontrolled arrhythmia, treatment for acute coronary syndrome (ACS) (myocardial infarction or unstable angina) or hospitalization for congestive heart failure within 3 months of screening or uncontrolled blood pressure (>160/100 mm Hg) at baseline (Screening and pre-dose at Week 1 visit )
• Women of childbearing potential defined as:
• Pre- or perimenopausal (<24 months of natural [spontaneous] amenorrhea).
• <6 weeks after surgical bilateral oophorectomy with or without hysterectomy.
• Prior treatment with pegloticase or another recombinant uricase
• Prior treatment or concomitant therapy with a polyethylene glycol (PEG) conjugated drug
• Known allergy to PEG products or history of anaphylactic reaction to a recombinant protein or porcine product
• Concurrent treatment with urate lowering agents (ULAs), such as allopurinol and febuxostat. Patients treated with these medications must discontinue treatment 7 days prior to the first dose of study drug
• Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
• Current liver disease as determined by alanine transaminase (ALT) or aspartate transaminase (AST) levels >3 times upper limit of normal (ULN)
• History of malignancy within 5 years other than basal cell skin cancer or carcinoma in situ of the cervix
• Has any other medical or psychological condition which, in the opinion of the Investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements, or to complete the study
• Solid organ transplant recipients
• Uncontrolled hyperglycemia with a plasma glucose value >240 mg/dL at screening
• Currently on dialysis
• Additional Exclusion Criteria for Imaging Sub-study Only
• Contraindication to receiving a gadolinium-based contrast agent (GBCA) or > 2 previous lifetime exposures to a GBCA
• Implanted pacemaker, certain older intracranial aneurysm clips, cochlear implants, certain prosthetic devices, implanted drug infusion pumps, neurostimulators, bone-growth stimulators, certain intrauterine contraceptive devices, or any other type of iron-based metal implants.
• Any internal metallic objects such as bullets or shrapnel, as well as most surgical clips, pins, plates, screws, metal sutures, or wire mesh.
• Additional Exclusion Criteria for FDG-PET-CT Sub-study Only
• Contraindication to FDG
• Additional Exclusion Criteria for Pegloticase and AZA Therapy Arm Only
• Any active serious bacterial infection (2 weeks prior to screening) requiring antibiotic treatment
• Severe chronic or recurrent bacterial infections, such as recurrent pneumonia, chronic bronchiectasis

Where it is running

• University of Alabama at Birminingham — Birmingham, Alabama, United States
• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Saint Paul Rheumatology — Eagan, Minnesota, United States
• Buffalo Rheumatology and Medicine — Orchard Park, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• ACME Research, LLC — Orangeburg, South Carolina, United States

Full record on ClinicalTrials.gov

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