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 all (27) locations...
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
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
California
Triwest Research Associates Llc
RECRUITING
El Cajon
Florida
Clinical Research of West Florida, Inc.
RECRUITING
Clearwater
Accel Research Sites - Deland Clinical Research Unit
RECRUITING
Deland
ICR Sites East
RECRUITING
Doral
Qway Research
RECRUITING
Hialeah
Bioclinical Research Alliance, Inc
RECRUITING
Miami
D&H National Research Centers (North Miami)
RECRUITING
Miami
Well Pharma Medical Research Group
RECRUITING
Miami
Combined Research Orlando Phase I-IV
RECRUITING
Orlando
Conquest Research - Lake Nona
RECRUITING
Orlando
New Horizons Research
RECRUITING
Palmetto Bay
Clinical Research of West Florida, Inc.
RECRUITING
Tampa
Georgia
Centricity Research - Columbus Georgia Multispecialty
RECRUITING
Columbus
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Pennsylvania
Altoona Center for Clinical Research
RECRUITING
Duncansville
Texas
Pioneer Research Solutions Inc
RECRUITING
Houston
Mt. Olympus Medical Research, LLC - Sugar Land
RECRUITING
Sugar Land
Other Locations
Georgia
Aleksandre Aladashvili Clinic LLC, Georgia
RECRUITING
Tbilisi
Georgian-Dutch Hospital, Georgia
RECRUITING
Tbilisi
LTD First Medical Center, Georgia
RECRUITING
Tbilisi
Mediclub Georgia
RECRUITING
Tbilisi
Tbilisi Heart and Vascular Clinic Ltd , Georgia
RECRUITING
Tbilisi
Tbilisi Institute of Medicine, Georgia
RECRUITING
Tbilisi
Israel
HaEmek MC, Israel
RECRUITING
Afula
Barzilai MC, Israel
RECRUITING
Ashkelon
Meir MC, Israel
RECRUITING
Kfar Saba
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