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)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Protalix
Study ID
NCT07280156
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRX-115 — BIOLOGICAL
    intravenous (IV) infusion
  • Methotrexate (MTX) — DRUG
    Oral MTX 15 mg weekly
  • PRX-115 placebo — OTHER
    intravenous (IV) infusion
  • Placebo-Methotrexate — OTHER
    Oral Placebo-MTX weekly

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6 [ Time Frame: 6 months of treatment ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Applied Research Center of ArkansasLittle RockArkansas72205-
Triwest Research Associates LlcEl CajonCalifornia91910-
Clinical Research of West Florida, Inc.ClearwaterFlorida33765-
Accel Research Sites - Deland Clinical Research UnitDeLandFlorida32720-
ICR Sites EastDoralFlorida33125-
Qway ResearchHialeahFlorida33010-
Bioclinical Research Alliance, IncMiamiFlorida33155-
D&H National Research Centers (North Miami)MiamiFlorida33169-
Well Pharma Medical Research GroupMiamiFlorida33173-
Combined Research Orlando Phase I-IVOrlandoFlorida32897-
Conquest Research - Lake NonaOrlandoFlorida32832-
New Horizons ResearchPalmetto BayFlorida33176-
Clinical Research of West Florida, Inc.TampaFlorida33606-
Centricity Research - Columbus Georgia MultispecialtyColumbusGeorgia31904-
Quest Research InstituteFarmington HillsMichigan48334-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Pioneer Research Solutions IncHoustonTexas77099-
Mt. Olympus Medical Research, LLC - Sugar LandSugar LandTexas77479-

Find similar trials in Little Rock, AR

By research site
Applied Research Center of Arkansas· Little Rock, ARTriwest Research Associates Llc· El Cajon, CAClinical Research of West Florida, Inc.· Clearwater, FLAccel Research Sites - Deland Clinical Research Unit· DeLand, FLICR Sites East· Doral, FLQway Research· Hialeah, FL

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