RecruitingPhase 2

A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)

United States150 participantsStarted 2025-12-22

Plain-language summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the respective placebos in adult patients with gout.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males or females ≥18 years of age.
✓. Weight within the range of 50.0 - 150.0 kg.
✓. Gout patients who failed to normalize sUA (\<7 mg/dL) with or without xanthine oxidase inhibitors or uricosuric agent or have contraindications to these drugs.
✓. Willing to discontinue any oral ULT
✓. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.

Exclusion criteria

✕. Any condition known to have arthritis as a clinical manifestation.
✕. Positive testing for HBV,HCV, or HIV.
✕. The patient is a pregnant or lactating female or plans to become pregnant during the study period.
✕. Known allergy or sensitivity to the injected proteins, including pegylated products.
✕. Prior exposure to any experimental or marketed uricase.
✕. Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs.
✕. History of anaphylaxis, severe allergic reactions, or severe atopy.
✕. G6PD deficiency or known catalase deficiency.

What they're measuring

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Timeframe: 6 months of treatment

Trial details

NCT IDNCT07280156

SponsorProtalix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Head of Clinical Development

+972-4-902-8100 info@protalix.com

View on ClinicalTrials.gov More Gout trials