Phase 3 Gout Trial, Recruiting NCT07388498 Sponsor: Amgen Condition: Gout
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Phase 3 Gout Trial, Recruiting

NCT07388498
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have agreed to take part and signed a consent form before any trial activities begin.
  • You are 18 years of age or older (or meet the legal adult age in your country, if that is older than 18).
  • You are willing and able to follow the treatment plan and attend all required visits for the full length of the trial.
  • You have gout that is not well controlled, as defined by specific measurements set out in the trial plan (confirm with trial site).

Who may not be able to join:

  • You have a condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency, which is a lack of a specific enzyme in the blood (this will be checked at your first screening visit).
  • Certain liver-related blood test results are above or below the normal range at your screening visit (confirm with trial site).
  • You have diabetes that is not well controlled, or a blood sugar measurement called HbA1c is above 8%.
  • You are known to have had a bad reaction or intolerance to a drug called methotrexate (MTX).
  • You have previously been treated with pegloticase, rasburicase, pegadricase, or any similar drug, or are currently taking a medication attached to a substance called polyethylene glycol (PEG).
  • You cannot tolerate any of the standard medicines used in this trial to help prevent gout flares, such as colchicine, anti-inflammatory painkillers, or a low-dose steroid called prednisone (you must be able to take at least one of these).
  • Your kidneys are not working well enough, based on a specific blood test measuring kidney function, or you are currently on dialysis (confirm with trial site for exact measurements).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: MD, Amgen

Phone: 866-572-6436

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
9 February 2026
Est. completion
18 June 2028

Where this trial is recruiting

Puerto Rico 🇺🇸 United States

Primary endpoints

Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov