Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegloticase · 1 trial · 1 indication
Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.
| Arm | Type | Description |
|---|---|---|
| Pegloticase SC with MTX | EXPERIMENTAL | Participants will receive pegloticase SC every two weeks with MTX. |
| Pegloticase IV with MTX | EXPERIMENTAL | Participants will receive pegloticase IV every two weeks with MTX. |
| Name | Type | Description |
|---|---|---|
| Pegloticase | DRUG | Participants will receive pegloticase either SC or IV. |
| Methotrexate | DRUG | MTX will be administered orally. |
Inclusion Criteria * 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 evaluat...
Pegloticase is an investigational drug being studied for the treatment of uncontrolled gout. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being evaluated in a clinical trial enrolling participants with uncontrolled gout.
Pegloticase is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting a Phase 3 clinical trial to investigate the drug's efficacy, safety, and pharmacokinetics in participants with uncontrolled gout.
Pegloticase is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants to evaluate the drug's efficacy, safety, and pharmacokinetics in patients with uncontrolled gout.
Pegloticase is being studied in a Phase 3 clinical trial registered as NCT07388498. This is a double-blind, randomized, controlled trial investigating the efficacy, safety, and pharmacokinetics of Pegloticase administered via subcutaneous and intravenous routes, both with methotrexate, in participants with uncontrolled gout. The trial is recruiting in the United States and Puerto Rico.
Pegloticase is a small molecule being studied for uncontrolled gout. The specific molecular target of Pegloticase has not been disclosed in the available information, so its mechanism of action is not described here. The ongoing clinical trial is designed to evaluate its efficacy and safety in patients with uncontrolled gout.