Search / Trial NCT06229145

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

Launched by AMGEN · Jan 19, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Uncontrolled Gout Pegloticase Krystexxa Methotrexate Chronic Gout

Description

Acquired from Horizon in 2024.

Gender

ALL

Eligibility criteria

  • 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.

About Amgen

Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.

Locations

Duncansville, Pennsylvania, United States

Denver, Colorado, United States

Aventura, Florida, United States

Spokane, Washington, United States

Louisville, Kentucky, United States

Houston, Texas, United States

Houston, Texas, United States

Gainesville, Georgia, United States

San Antonio, Texas, United States

Amarillo, Texas, United States

Houston, Texas, United States

Santa Monica, California, United States

Phoenix, Arizona, United States

Chicago, Illinois, United States

Plano, Texas, United States

Whittier, California, United States

Greensboro, North Carolina, United States

Glendale, Arizona, United States

Meridian, Idaho, United States

Houston, Texas, United States

Charlotte, North Carolina, United States

Winter Park, Florida, United States

Hialeah, Florida, United States

Birmingham, Alabama, United States

Tampa, Florida, United States

Doral, Florida, United States

Saint Clair Shores, Michigan, United States

Anchorage, Alaska, United States

Margate, Florida, United States

Covina, California, United States

Cincinnati, Ohio, United States

San Diego, California, United States

Phoenix, Arizona, United States

Denver, North Carolina, United States

Colorado Springs, Colorado, United States

Houston, Texas, United States

Spokane, Washington, United States

Cincinnati, Ohio, United States

Greenville, South Carolina, United States

Denver, North Carolina, United States

Gurnee, Illinois, United States

Shelby, North Carolina, United States

West Jordan, Utah, United States

Miami, Florida, United States

West Jordan, Utah, United States

Tampa, Florida, United States

Newnan, Georgia, United States

Newnan, Georgia, United States

Naples, Florida, United States

Beachwood, Ohio, United States

San Leandro, California, United States

Santa Fe, New Mexico, United States

Miami, Florida, United States

Houston, Texas, United States

Portsmouth, Virginia, United States

Tamarac, Florida, United States

Covina, California, United States

Riverside, California, United States

San Diego, California, United States

Tujunga, California, United States

Tamarac, Florida, United States

Summerville, South Carolina, United States

San Antonio, Texas, United States

Chandler, Arizona, United States

Flagstaff, Arizona, United States

Gilbert, Arizona, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Meridian, Idaho, United States

Gurnee, Illinois, United States

Lansing, Michigan, United States

Beachwood, Ohio, United States

Rock Hill, South Carolina, United States

Amarillo, Texas, United States

Anchorage, Alaska, United States

Chandler, Arizona, United States

Flagstaff, Arizona, United States

Gilbert, Arizona, United States

Mesa, Arizona, United States

Sun City, Arizona, United States

Tucson, Arizona, United States

San Leandro, California, United States

Temecula, California, United States

Tujunga, California, United States

Aventura, Florida, United States

Margate, Florida, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Lansing, Michigan, United States

Vestal, New York, United States

Oklahoma City, Oklahoma, United States

Rock Hill, South Carolina, United States

Summerville, South Carolina, United States

Plano, Texas, United States

Portsmouth, Virginia, United States

Doral, Florida, United States

Hinsdale, Illinois, United States

Miami, Florida, United States

Leland, North Carolina, United States

Plantation, Florida, United States

Temecula, California, United States

Miami, Florida, United States

New Orleans, Louisiana, United States

Sugar Land, Texas, United States

Miami, Florida, United States

New Orleans, Louisiana, United States

Hemet, California, United States

Riverside, California, United States

Pompano Beach, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0