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)
Public ClinicalTrials.gov record NCT07280156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07280156
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Interventions
- PRX-115 Biological
- Methotrexate (MTX) Drug
- PRX-115 placebo Other
- Placebo-Methotrexate Other
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2025
- Primary completion
- Nov 30, 2027
- Completion
- May 31, 2028
- Last update posted
- Jun 10, 2026
2025 – 2028
United States locations
- U.S. sites
- 18
- U.S. states
- 7
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | Recruiting |
| Triwest Research Associates Llc | El Cajon | California | 91910 | Recruiting |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | Recruiting |
| Accel Research Sites - Deland Clinical Research Unit | DeLand | Florida | 32720 | Recruiting |
| ICR Sites East | Doral | Florida | 33125 | Recruiting |
| Qway Research | Hialeah | Florida | 33010 | Recruiting |
| Bioclinical Research Alliance, Inc | Miami | Florida | 33155 | Recruiting |
| D&H National Research Centers (North Miami) | Miami | Florida | 33169 | Recruiting |
| Well Pharma Medical Research Group | Miami | Florida | 33173 | Recruiting |
| Conquest Research - Lake Nona | Orlando | Florida | 32832 | Recruiting |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32897 | Recruiting |
| New Horizons Research | Palmetto Bay | Florida | 33176 | Recruiting |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | Recruiting |
| Centricity Research - Columbus Georgia Multispecialty | Columbus | Georgia | 31904 | Recruiting |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | Recruiting |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | Recruiting |
| Pioneer Research Solutions Inc | Houston | Texas | 77099 | Recruiting |
| Mt. Olympus Medical Research, LLC - Sugar Land | Sugar Land | Texas | 77479 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07280156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07280156 live on ClinicalTrials.gov.