Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Public ClinicalTrials.gov record NCT02959918. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open Label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 Followed by Open Label Administration of SEL-037 in Subjects With Symptomatic Gout and Elevated Blood Uric Acid
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses ( 5 monthly IV infusions) of pegsiticase (SEL-037) alone. Participants will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to weekly serum uric acid levels.
Study identification
- NCT ID
- NCT02959918
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 152 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2016 (Actual)
- Primary completion
- Dec 2018 (Actual)
- Completion
- Jan 2019 (Actual)
- Last update posted
- Feb 14, 2022
2016 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| Tri West Research Associates LLC | El Cajon | California | 92020 | — |
| Irvine Center for Clinical Research Inc. | Irvine | California | 92614 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Omega Research Consultants LLC | DeBary | Florida | 32713 | — |
| Compass Research LLC | Orlando | Florida | 32806 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Advanced Clinical Research | Boise | Idaho | 83642 | — |
| L-MARC | Louisville | Kentucky | 40213 | — |
| Triad Clinical Trials LLC | Greensboro | North Carolina | 27410 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02959918, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02959918 live on ClinicalTrials.gov.