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NCT06229145

PHASE4

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.

Official title: A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

306

Start Date

2024-03-18

Completion Date

2026-03-26

Last Updated

2026-09-16

Healthy Volunteers

Conditions

Gout

Interventions

BIOLOGICAL

Pegloticase

IV infusion

DRUG

Methotrexate

Oral

Inclusion Criteria: 1. Adult men or women ≥ 18 years of age 2. Uncontrolled gout, defined as meeting the following criteria: * Hyperuricemia during the Screening Period, defined as sUA ≥ 7 mg/dL, and; * Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or participant interview, and; * Symptoms of gout 3. Willing to discontinue any oral ULT for at least 7 days prior to MTX dosing at Week -4 and continue not receiving any oral ULT when receiving pegloticase/placebo for pegloticase infusions 4. Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4. 5. Men who are not vasectomized must agree to use appropriate contraception, so as to not impregnate a female partner of reproductive potential during the trial. Exclusion Criteria: 1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis 2. Current or chronic treatment with systemic immunosuppressive agents, such as MTX, azathioprine or mycophenolate mofetil; prednisone \> 10 mg/day or equivalent dose of other corticosteroid on a chronic basis (3 months or longer) 3. History of any transplant surgery requiring maintenance immunosuppressive therapy 4. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity 5. Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative 6. Known history of human immunodeficiency virus (HIV) positivity 7. G6PD deficiency (quantitative test at the Screening Visit centrally or locally) 8. Non-compensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina) or uncontrolled blood pressure (\> 160/100 mmHg) prior to Week -4 9. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner or not on an effective form of birth control, as determined by the Investigator 10. Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug 11. Unable to tolerate MTX 15 mg orally during the MTX Run-in Period 12. Chronic liver disease 13. White blood cell count \< 4,000/μL, hematocrit \< 32% or platelet count \< 75,000/μL 14. Currently receiving systemic or radiologic treatment for ongoing cancer 15. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix 16. Diagnosis of osteomyelitis 17. Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome 18. A known intolerance to all protocol-standard gout flare prophylaxis regimens (i.e., participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day) 19. Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening.

Locations (74)

The University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Orthopedic Physicians Alaska - Rheumatology and Infusion

Anchorage, Alaska, United States

Arizona Arthritis and Rheumatology Associates - Chandler

Chandler, Arizona, United States

Arizona Arthritis and Rheumatology Rese

Flagstaff, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, United States

Arizona Arthritis and Rheumatology Research, PLLC

Mesa, Arizona, United States

Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, United States

Arizona Arthritis and Rheumatology Research

Phoenix, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, United States

Arizona Arthritis and Rheumatology

Tucson, Arizona, United States

Covina Arthritis Clinic

Covina, California, United States

Medvin Clinical Research- Riverside

Hemet, California, United States

Velocity Clinical Research - Boise - ERN - PPDS

North Hollywood, California, United States

TriWest Research Associates

San Diego, California, United States

Precision Comprehensive Clinical Research Solutions

San Leandro, California, United States

Saint John's Health Center - Providence St John's Health Ctr

Santa Monica, California, United States

C.V. Mehta MD Medical Corporation

Temecula, California, United States

Foothill Arthritis

Tujunga, California, United States

Medvin Clinical Research

Whittier, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Lynn Institute of the Rockies

Colorado Springs, Colorado, United States

Denver Arthritis Clinic - Rheumatology

Denver, Colorado, United States

Arthritis & Rheumatic Disease

Aventura, Florida, United States

Prohealth Research Center

Doral, Florida, United States

Life Clinical Trials

Margate, Florida, United States

Homestead Associates in Research,Inc

Miami, Florida, United States

D&H National Research Centers, Inc.

Miami, Florida, United States

Well Pharma

Miami, Florida, United States

Felicidad Medical Research, LLC.

Miami, Florida, United States

New Generation Of Medical Research

Naples, Florida, United States

IRIS Research & Development

Plantation, Florida, United States

D&H Pompano Research Center

Pompano Beach, Florida, United States

D&H Tamarac Research Center

Tamarac, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

ClinPro Research Solutions, LLC

Tampa, Florida, United States

Arthritis Center of North Georgia

Gainesville, Georgia, United States

Vista Clinical Research, LLC

Newnan, Georgia, United States

Great Lakes Clin. Trials

Chicago, Illinois, United States

Conquest Research - Anesthesiology/Pain Medicine

Chicago, Illinois, United States

Great Lakes Clinical Trials - Gurnee

Highland Park, Illinois, United States

Crowley CORE - Illinois Bone and Joint Institute

Hinsdale, Illinois, United States

Lake Cumberland Rheumatology, PLLC

New Albany, Indiana, United States

L-MARC Research Center

Louisville, Kentucky, United States

Velocity CR - New Orleans

Covington, Louisiana, United States

Velocity CR - New Orleans

New Orleans, Louisiana, United States

Michigan Medicine

Ann Arbor, Michigan, United States

June DO,PC

Lansing, Michigan, United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

Inspire Santa Fe Medical Group

Santa Fe, New Mexico, United States

Velocity Clinical Research-Vestal

Vestal, New York, United States

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Research Carolina Elite

Denver, North Carolina, United States

Triad Clinical Trials - Gastroenterology

Greensboro, North Carolina, United States

Accellacare of Hickory

Hickory, North Carolina, United States

Cape Fear Arthritis Care

Leland, North Carolina, United States

Shelby Clinical Research - Family Medicine

Shelby, North Carolina, United States

Velocity Clinical Research- Cincinatti

Cincinnati, Ohio, United States

Velocity Clinical Research - Cleveland

Cleveland, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Velocity Clinical Research, Spartanburg - Pulmonology

Greenville, South Carolina, United States

Premier Clinics Pa - Rock Hill, Sc

Rock Hill, South Carolina, United States

Low Country Rheumatology

Summerville, South Carolina, United States

Amarillo Center for Clinical Research, Ltd.

Amarillo, Texas, United States

Clinical Trial Network

Austin, Texas, United States

Synergy Groups Medical LLC

Houston, Texas, United States

Pioneer Research Solutions, Inc.

Houston, Texas, United States

AIM Trials - Internal Medicine

Plano, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Texas Research Center

Sugar Land, Texas, United States

Velocity Clinical Research - Salt Lake City (West Jordan)

West Jordan, Utah, United States

Velocity Clinical Research-Portsmouth

Portsmouth, Virginia, United States

Arthritis Northwest, PLLC - Research

Spokane, Washington, United States

Clinical Research Directory

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (74)