A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Public ClinicalTrials.gov record NCT07388498. 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 Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
Study identification
- NCT ID
- NCT07388498
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Amgen
- Industry
- Enrollment
- 270 participants
Conditions and interventions
Conditions
Interventions
- Methotrexate Drug
- Pegloticase Drug
Drug
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
- Feb 8, 2026
- Primary completion
- May 22, 2028
- Completion
- Jul 17, 2028
- Last update posted
- May 3, 2026
2026 – 2028
United States locations
- U.S. sites
- 36
- U.S. states
- 13
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Solace Clinical Research | Tustin | California | 92780 | Recruiting |
| Denver Arthritis Clinic PC | Denver | Colorado | 80230 | Recruiting |
| D and H Pompano Research Center | Aventura | Florida | 33180 | Recruiting |
| New Generation of Medical Research | Hialeah | Florida | 33016 | Recruiting |
| Homestead Associates In Research Inc | Homestead | Florida | 33033 | Recruiting |
| Well Pharma Medical Research Corp | Miami | Florida | 33143 | Recruiting |
| D and H National Research Centers | Miami | Florida | 33155 | Recruiting |
| Advanced Clinical Research | Miami | Florida | 33156 | Recruiting |
| Felicidad Medical Research | Miami | Florida | 33184 | Recruiting |
| Decision Management International Research | Pinellas Park | Florida | 33782 | Recruiting |
| Integral Rheumatology and Immunology Specialists | Plantation | Florida | 33324 | Recruiting |
| D and H Tamarac Research Center | Tamarac | Florida | 33321 | Recruiting |
| GCP Clinical Research, LLC | Tampa | Florida | 33609 | Recruiting |
| ClinPro Research Solutions LLC | Tampa | Florida | 33613 | Recruiting |
| Conquest Research - Winter Park | Winter Park | Florida | 32789 | Recruiting |
| Spatium Urgent Care | Marietta | Georgia | 30066 | Recruiting |
| Vista Clinical Research | Newnan | Georgia | 30265 | Recruiting |
| Charter Research | Chicago | Illinois | 60618 | Recruiting |
| Flourish Research Ravenswood | Chicago | Illinois | 60640 | Recruiting |
| Greater Chicago Specialty Physicians | Schaumburg | Illinois | 60195 | Recruiting |
| Willow Rheumatology and Wellness | Willowbrook | Illinois | 60527 | Recruiting |
| Kur Research at Columbia Medical Practice | Columbia | Maryland | 21045 | Recruiting |
| MD Medical Research | Oxon Hill | Maryland | 20745 | Recruiting |
| Buffalo Rheumatology and Medicine | Orchard Park | New York | 14127 | Recruiting |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | Recruiting |
| Cape Fear Arthritis Care, PLLC | Leland | North Carolina | 28451 | Recruiting |
| Accellacare Salisbury | Salisbury | North Carolina | 28144 | Recruiting |
| Carolina Research Center Inc | Shelby | North Carolina | 28150 | Recruiting |
| Shelby Clinical Research | Shelby | North Carolina | 28150 | Recruiting |
| Paramount Medical Research and Consulting LLC | Middleburg Heights | Ohio | 44130 | Recruiting |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | Recruiting |
| Articularis Healthcare Group Inc dba Low Country Rheumatology | Summerville | South Carolina | 29486 | Recruiting |
| Pioneer Research Solutions Inc | Houston | Texas | 77099 | Recruiting |
| Epic Clinical Research | Lewisville | Texas | 75057 | Recruiting |
| Be Well Clinical Studies | Round Rock | Texas | 78681 | Recruiting |
| Overlake Arthritis and Osteoperosis Center | Bellevue | Washington | 98004 | 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07388498, 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 May 3, 2026 · Synced May 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07388498 live on ClinicalTrials.gov.