Gout drug pegloticase gets a shot in the arm: new subcutaneous option tested

NCT ID NCT07388498

Recruiting now Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 7 times

Summary

This phase 3 trial tests whether a subcutaneous (under-the-skin) injection of pegloticase works as well as the standard intravenous (IV) infusion for people with uncontrolled gout. About 270 adults will receive either the shot or the IV, both with weekly methotrexate. The goal is to see if uric acid levels stay normal for most of the sixth month of treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: pegloticase (KRYSTEXXA) with methotrexate
What this could lead to: If successful, this could offer a more convenient subcutaneous injection option for controlling gout, reducing the need for intravenous infusions.
What could go wrong: This is a phase 3 trial, but results may not confirm superiority or non-inferiority of the SC route. Risks include injection site reactions and allergic reactions.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

UNCONTROLLED GOUT

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Accellacare Salisbury
RECRUITING

Salisbury, North Carolina, 28144, United States
Advanced Clinical Research
RECRUITING

Miami, Florida, 33156, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates
RECRUITING

Chula Vista, California, 91910, United States
Altoona Center for Clinical Research
RECRUITING

Duncansville, Pennsylvania, 16635, United States
Arthritis Northwest Professional Limited Liability Company
RECRUITING

Spokane, Washington, 99204, United States
Articularis Healthcare Group Inc dba Low Country Rheumatology
RECRUITING

Summerville, South Carolina, 29486, United States
Bay Pines Veterans Affairs Healthcare System
RECRUITING

Bay Pines, Florida, 33744, United States
Be Well Clinical Studies
RECRUITING

Round Rock, Texas, 78681, United States
Biopharma Informatic, LLC
RECRUITING

Katy, Texas, 77494, United States
Buffalo Rheumatology and Medicine
RECRUITING

Orchard Park, New York, 14127, United States
Cape Fear Arthritis Care, PLLC
RECRUITING

Leland, North Carolina, 28451, United States
Caribbean Health Research Center
RECRUITING

San Juan, 00917, Puerto Rico
Carolina Research Center Inc
RECRUITING

Shelby, North Carolina, 28150, United States
Charter Research
RECRUITING

Chicago, Illinois, 60618, United States
ClinPro Research Solutions LLC
RECRUITING

Tampa, Florida, 33613, United States
Clinical Research Institute of Michigan
RECRUITING

Saint Clair Shores, Michigan, 48081, United States
Clinical Trials Management, LLC, d/b/a Flourish Research
RECRUITING

Mandeville, Louisiana, 70471, United States
Conquest Research - Winter Park
RECRUITING

Winter Park, Florida, 32789, United States
D and H National Research Centers
RECRUITING

Miami, Florida, 33155, United States
D and H Pompano Research Center
RECRUITING

Aventura, Florida, 33180, United States
D and H Tamarac Research Center
RECRUITING

Tamarac, Florida, 33321, United States
Decision Management International Research
RECRUITING

Pinellas Park, Florida, 33782, United States
Denver Arthritis Clinic PC
RECRUITING

Denver, Colorado, 80230, United States
Entrust Clinical Research
RECRUITING

Miami, Florida, 33176, United States
Epic Clinical Research
RECRUITING

Lewisville, Texas, 75057, United States
Felicidad Medical Research
RECRUITING

Miami, Florida, 33184, United States
Flourish Research Ravenswood
RECRUITING

Chicago, Illinois, 60640, United States
GCP Clinical Research, LLC
RECRUITING

Tampa, Florida, 33609, United States
Greater Chicago Specialty Physicians
RECRUITING

Schaumburg, Illinois, 60195, United States
Health Concepts
RECRUITING

Rapid City, South Dakota, 57702, United States
Hillcrest Medical Research
RECRUITING

DeLand, Florida, 32720, United States
Homestead Associates In Research Inc
RECRUITING

Homestead, Florida, 33033, United States
Inspire Santa Fe Medical Group
RECRUITING

Santa Fe, New Mexico, 87505, United States
Integral Rheumatology and Immunology Specialists
RECRUITING

Plantation, Florida, 33324, United States
Joint and Muscle Research Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Kur Research at Columbia Medical Practice
RECRUITING

Columbia, Maryland, 21045, United States
Lynn Health Science Institute
RECRUITING

Oklahoma City, Oklahoma, 73111, United States
MD Medical Research
RECRUITING

Oxon Hill, Maryland, 20745, United States
New Generation of Medical Research
RECRUITING

Hialeah, Florida, 33016, United States
Nodal Medical Center Research
RECRUITING

Tampa, Florida, 33607, United States
Onsite Clinical Solutions, LLC
RECRUITING

Charlotte, North Carolina, 28211, United States
Orthopedic Physicians Alaska
RECRUITING

Anchorage, Alaska, 99508, United States
Overlake Arthritis and Osteoperosis Center
RECRUITING

Bellevue, Washington, 98004, United States
Paramount Medical Research and Consulting LLC
RECRUITING

Middleburg Heights, Ohio, 44130, United States
Pharmax Research Clinic
RECRUITING

Miami, Florida, 33126, United States
Pioneer Research Solutions Inc
RECRUITING

Houston, Texas, 77099, United States
Precision Rheumatology
RECRUITING

Anaheim, California, 92802, United States
Raymond G Murphy Veteran Affairs Medical Center
RECRUITING

Albuquerque, New Mexico, 87108, United States
Research Carolina Elite
RECRUITING

Denver, North Carolina, 28037, United States
Research Physicians Network, LLC
RECRUITING

Houston, Texas, 77089, United States
Saint Lukes Intermountain Research Center
RECRUITING

Boise, Idaho, 83702, United States
Shelby Clinical Research
RECRUITING

Shelby, North Carolina, 28150, United States
Siena Research Network
RECRUITING

Sugar Land, Texas, 77479, United States
Solace Clinical Research
RECRUITING

Tustin, California, 92780, United States
Southwest Rheumatology
RECRUITING

Dallas, Texas, 75230, United States
Spatium Urgent Care
RECRUITING

Marietta, Georgia, 30066, United States
Texas Arthritis & Rheumatology Associates
RECRUITING

Katy, Texas, 77450, United States
Triad Clinical Trials, LLC
RECRUITING

Greensboro, North Carolina, 27410, United States
University of Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35294, United States
Vista Clinical Research
RECRUITING

Newnan, Georgia, 30265, United States
Well Pharma Medical Research Corp
RECRUITING

Miami, Florida, 33143, United States
West Tennessee Research Institute
RECRUITING

Jackson, Tennessee, 38305, United States
Willow Rheumatology and Wellness
RECRUITING

Willowbrook, Illinois, 60527, United States

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