Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout (NCT06186219) | Clinical Trial Compass
CompletedPhase 1
Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout
United States2 participantsStarted 2024-04-10
Plain-language summary
This safety and feasibility, open-label study of up to 9 subjects will examine a group of subjects with poorly controlled tophaceous gout (intolerant to or ineffective oral urate lowering agents and loss of prior Pegloticase response) pre-treated with Rituximab to recapture response to Methotrexate-Pegloticase.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must be able to provide written informed consent.
✓. Male or female ≥ 18 years of age at Baseline Visit.
✓. Meets the American College of Rheumatology Classification Criteria for Gout.
✓. Poorly controlled tophaceous gout, defined as meeting the following criteria:
✓. Hyperuricemia during the screening period defined as serum urate ≥ 6 mg/dL.
✓. Failure to maintain normalization of serum urate with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview, and;
✓. Symptoms of gout including at least 1 of the following:
✓. Prior discontinued use of Pegloticase due to failure (rising SU \> 6 mg/dL or history of moderate to severe infusion reaction).
Exclusion criteria
✕. Glucose-6-phosphate dehydrogenase deficiency (documented or tested at the Screening Visit).
✕. Chronic renal impairment defined as estimated glomerular filtration rate (epidermal growth factor receptor) \< 30 mL/min/1.73 m2 or currently on dialysis.
✕. Non-compensated congestive heart failure (stage C) or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia.
What they're measuring
1
The study will be measured by the frequency and grade of adverse event (AEs) (solicited and unsolicited), serious adverse experience (SAEs), adverse event of special interest (AESI1s), medically attended adverse events (MAAEs).
Timeframe: 2 years
2
Neutralizing antibody titers (assays provided by Horizon labs) will be measured at Screening (Visit 0), prior to first Pegloticase infusion (Visit 3, Week 0), Visit 9, Week 12 and Visit 16, Week 26.