A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Efficacy, Safety, and Dosing Regimen Selection of Multiple Intravenous Infusions of PRX-115 With and Without Methotrexate Versus Placebo in Adult Patients With Gout (RELEASE)
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Bioclinical Research Alliance, Inc
RECRUITING
Miami
Contact Information
Primary
Head of Clinical Development
info@protalix.com
+972-4-902-8100
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2028-06
Participants
Target number of participants: 150
Treatments
Experimental: E4W with placebo-MTX
IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
Experimental: E4W with MTX
IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with MTX
Experimental: E6W with MTX
IV infusion of PRX-115 every 6 weeks (E6W) for a total of 4 doses with MTX
Experimental: E8W with MTX
IV infusion of PRX-115 every 8 weeks (E8W) for a total of 3 doses with MTX
Placebo_comparator: placebo E4W
infusion of PRX-115 placebo every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
Placebo_comparator: placebo E6W
IV infusion of PRX-115 placebo every 6 weeks (E6W) for a total of 4 doses with placebo-MTX
Sponsors
Leads: Protalix