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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07388498

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.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:23 PM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.

Study identification

NCT ID
NCT07388498
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
270 participants

Conditions and interventions

Interventions

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
Jun 17, 2028
Completion
Jun 17, 2028
Last update posted
Sep 2, 2026

2026 – 2028

United States locations

U.S. sites
70
U.S. states
24
U.S. cities
56
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 Recruiting
Orthopedic Physicians Alaska Anchorage Alaska 99508 Recruiting
Precision Rheumatology Anaheim California 92802 Recruiting
Advanced Clinical Research Center, LLC dba TriWest Research Associates Chula Vista California 91910 Recruiting
Solace Clinical Research Tustin California 92780 Recruiting
Denver Arthritis Clinic PC Denver Colorado 80230 Recruiting
Arthritis and Rheumatic Disease Specialties Aventura Florida 33180 Recruiting
D and H Pompano Research Center Aventura Florida 33180 Recruiting
Bay Pines Veterans Affairs Healthcare System Bay Pines Florida 33744 Recruiting
Discovery Health Research Center Coral Springs Florida 33065 Recruiting
Hillcrest Medical Research DeLand Florida 32720 Recruiting
New Generation of Medical Research Hialeah Florida 33016 Recruiting
Homestead Associates In Research Inc Homestead Florida 33033 Recruiting
Pharmax Research Clinic Miami Florida 33126 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
Entrust Clinical Research Miami Florida 33176 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
Nodal Medical Center Research Tampa Florida 33607 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
Saint Lukes Intermountain Research Center Boise Idaho 83702 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
Clinical Trials Management, LLC, d/b/a Flourish Research Mandeville Louisiana 70471 Recruiting
Kur Research at Columbia Medical Practice Columbia Maryland 21045 Recruiting
MD Medical Research Oxon Hill Maryland 20745 Recruiting
June DO PC Lansing Michigan 48911 Recruiting
Clinical Research Institute of Michigan Saint Clair Shores Michigan 48081 Recruiting
Oakland Medical Research Center Troy Michigan 48085 Recruiting
Bioluminux Clinical Research - Hamilton Hamilton New Jersey 08690 Recruiting
Raymond G Murphy Veteran Affairs Medical Center Albuquerque New Mexico 87108 Recruiting
Inspire Santa Fe Medical Group Santa Fe New Mexico 87505 Recruiting
Buffalo Rheumatology and Medicine Orchard Park New York 14127 Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina 28202 Recruiting
Joint and Muscle Research Institute Charlotte North Carolina 28204 Recruiting
Onsite Clinical Solutions, LLC Charlotte North Carolina 28211 Recruiting
Research Carolina Elite Denver North Carolina 28037 Recruiting
Triad Clinical Trials, LLC Greensboro North Carolina 27410 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
Ohio State University Wexner Medical Center Clinical Research Center Columbus Ohio 43210 Recruiting
Paramount Medical Research and Consulting LLC Middleburg Heights Ohio 44130 Recruiting
Lynn Health Science Institute Oklahoma City Oklahoma 73111 Recruiting
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 Recruiting
Articularis Healthcare Group Inc dba Low Country Rheumatology Summerville South Carolina 29486 Recruiting
Health Concepts Rapid City South Dakota 57702 Recruiting
West Tennessee Research Institute Jackson Tennessee 38305 Recruiting
Southwest Rheumatology Dallas Texas 75230 Recruiting
Research Physicians Network, LLC Houston Texas 77089 Recruiting
Pioneer Research Solutions Inc Houston Texas 77099 Recruiting
Texas Arthritis & Rheumatology Associates Katy Texas 77450 Recruiting
Biopharma Informatic, LLC Katy Texas 77494 Recruiting
Epic Clinical Research Lewisville Texas 75057 Recruiting
Be Well Clinical Studies Round Rock Texas 78681 Recruiting
Siena Research Network Sugar Land Texas 77479 Recruiting
Virginia Commonwealth University Richmond Virginia 23298 Recruiting
Overlake Arthritis and Osteoperosis Center Bellevue Washington 98004 Recruiting
Arthritis Northwest Professional Limited Liability Company Spokane Washington 99204 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 Sep 2, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07388498 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →