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NCT07280156 · ClinicalTrials.gov registry record · Phase 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)
A Phase 2 study of Gout, sponsored by Protalix.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT07280156 is a Phase 2 study of Gout that is actively recruiting participants, run by Protalix. The registered enrollment target is 150 participants, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07280156, a Phase 2 study of Gout, is actively recruiting participants, sponsored by Protalix.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Methotrexate (MTX)
- BIOLOGICAL PRX-115
- OTHER PRX-115 placebo
- OTHER Placebo-Methotrexate
Study Locations (1)
Florida
- Bioclinical Research Alliance, Inc - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07280156
The ClinicalTrials.gov registry entry for NCT07280156 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower). The listed sponsor is Protalix, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 4 interventions - of which Methotrexate (MTX) is the first listed.
NCT07280156 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT07280156 about?
NCT07280156 is a clinical study titled "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)". 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.
What is the current status of trial NCT07280156?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-12-22. Estimated completion is 2028-06.
What conditions does trial NCT07280156 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT07280156?
The interventions under investigation include: Methotrexate (MTX) (DRUG), PRX-115 (BIOLOGICAL), PRX-115 placebo (OTHER), Placebo-Methotrexate (OTHER).
Who is sponsoring clinical trial NCT07280156?
This trial is sponsored by Protalix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07280156 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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