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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: Recruiting Phase 2 study of Gout, sponsored by Protalix.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of patients who achieve a reduction in sUA to \<6.0 mg/dL for at least 80% of the time during Month 6
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 |
What NCT07280156 shows while recruiting
NCT07280156 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07280156's enrollment target sits among peer trials
150 15th of 34 higher than 19 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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