# A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout

> **NCT07388498** · PHASE3 · RECRUITING · sponsor: **Amgen** · enrollment: 270 (estimated)

## Conditions studied

- Uncontrolled Gout

## Interventions

- **DRUG:** Pegloticase
- **DRUG:** Methotrexate

## Key facts

- **NCT ID:** NCT07388498
- **Lead sponsor:** Amgen
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-02-09
- **Primary completion:** 2028-05-23
- **Final completion:** 2028-07-18
- **Target enrollment:** 270 (ESTIMATED)
- **Last updated:** 2026-05-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07388498

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07388498, "A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT07388498. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*