Status and phase
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About
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout.
The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time.
Full description
Acquired from Horizon in 2024.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adult men or women ≥ 18 years of age
Uncontrolled gout, defined as meeting the following criteria:
Willing to discontinue any oral ULT for at least 7 days prior to MTX dosing at Week -4 and continue not receiving any oral ULT when receiving pegloticase/placebo for pegloticase infusions
Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4.
Men who are not vasectomized must agree to use appropriate contraception, so as to not impregnate a female partner of reproductive potential during the trial.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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