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
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant has provided informed consent before initiation of any trial-specific activities/procedures.
• Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
• Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
• Participants with uncontrolled gout, as meeting the protocol defined criteria.
Locations
United States
Alaska
Orthopedic Physicians Alaska
RECRUITING
Anchorage
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Solace Clinical Research
RECRUITING
Tustin
Colorado
Denver Arthritis Clinic PC
RECRUITING
Denver
Florida
D and H Pompano Research Center
RECRUITING
Aventura
Bay Pines Veterans Affairs Healthcare System
RECRUITING
Bay Pines
Hillcrest Medical Research
RECRUITING
Deland
New Generation of Medical Research
RECRUITING
Hialeah
Homestead Associates In Research Inc
RECRUITING
Homestead
Advanced Clinical Research
RECRUITING
Miami
D and H National Research Centers
RECRUITING
Miami
Entrust Clinical Research
RECRUITING
Miami
Felicidad Medical Research
RECRUITING
Miami
Pharmax Research Clinic
RECRUITING
Miami
Well Pharma Medical Research Corp
RECRUITING
Miami
Decision Management International Research
RECRUITING
Pinellas Park
Integral Rheumatology and Immunology Specialists
RECRUITING
Plantation
D and H Tamarac Research Center
RECRUITING
Tamarac
ClinPro Research Solutions LLC
RECRUITING
Tampa
GCP Clinical Research, LLC
RECRUITING
Tampa
Nodal Medical Center Research
RECRUITING
Tampa
Conquest Research - Winter Park
RECRUITING
Winter Park
Georgia
Spatium Urgent Care
RECRUITING
Marietta
Vista Clinical Research
RECRUITING
Newnan
Illinois
Charter Research
RECRUITING
Chicago
Flourish Research Ravenswood
RECRUITING
Chicago
Greater Chicago Specialty Physicians
RECRUITING
Schaumburg
Willow Rheumatology and Wellness
RECRUITING
Willowbrook
Louisiana
Mandeville Private Physicians Group
RECRUITING
Mandeville
Maryland
Kur Research at Columbia Medical Practice
RECRUITING
Columbia
MD Medical Research
RECRUITING
Oxon Hill
North Carolina
Joint and Muscle Research Institute
RECRUITING
Charlotte
Onsite Clinical Solutions, LLC
RECRUITING
Charlotte
Research Carolina Elite
RECRUITING
Denver
Triad Clinical Trials, LLC
RECRUITING
Greensboro
Cape Fear Arthritis Care, PLLC
RECRUITING
Leland
Accellacare Salisbury
RECRUITING
Salisbury
Carolina Research Center Inc
RECRUITING
Shelby
Shelby Clinical Research
RECRUITING
Shelby
New Mexico
Raymond G Murphy Veteran Affairs Medical Center
RECRUITING
Albuquerque
New York
Buffalo Rheumatology and Medicine
RECRUITING
Orchard Park
Ohio
Paramount Medical Research and Consulting LLC
RECRUITING
Middleburg Heights
Oklahoma
Lynn Health Science Institute
RECRUITING
Oklahoma City
Pennsylvania
Altoona Center for Clinical Research
RECRUITING
Duncansville
South Carolina
Articularis Healthcare Group Inc dba Low Country Rheumatology
RECRUITING
Summerville
Texas
Pioneer Research Solutions Inc
RECRUITING
Houston
Research Physicians Network, LLC
RECRUITING
Houston
Biopharma Informatic, LLC
RECRUITING
Katy
Epic Clinical Research
RECRUITING
Lewisville
Be Well Clinical Studies
RECRUITING
Round Rock
Washington
Overlake Arthritis and Osteoperosis Center
RECRUITING
Bellevue
Arthritis Northwest Professional Limited Liability Company
RECRUITING
Spokane
Other Locations
Puerto Rico
Caribbean Health Research Center
RECRUITING
San Juan
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2028-06-18
Participants
Target number of participants: 270
Treatments
Experimental: Pegloticase SC with MTX
Participants will receive pegloticase SC every two weeks with MTX.
Experimental: Pegloticase IV with MTX
Participants will receive pegloticase IV every two weeks with MTX.
Sponsors
Leads: Amgen