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NCT02959918 · ClinicalTrials.gov registry record · Phase 2
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
A Phase 2 study, sponsored by Selecta Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
NCT02959918: Completed Phase 2 study, sponsored by Selecta Biosciences.
NCT02959918 is a Phase 2 study that has completed, run by Selecta Biosciences. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02959918, a Phase 2 study, has completed, sponsored by Selecta Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set
Interventions
- DRUG SEL-212
- DRUG SEL-037
- DRUG SVP-rapamycin (SEL-110)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-01 |
| Phase | Phase 2 |
What the finished NCT02959918 record still lists
NCT02959918 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 3 interventions - of which SEL-212 is the first listed.
NCT02959918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02959918 about?
NCT02959918 is a clinical study titled "Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid". 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 o...
What is the current status of trial NCT02959918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2016-10. Estimated completion is 2019-01.
What interventions are being tested in trial NCT02959918?
The interventions under investigation include: SEL-212 (DRUG), SEL-037 (DRUG), SVP-rapamycin (SEL-110) (DRUG).
Who is sponsoring clinical trial NCT02959918?
This trial is sponsored by Selecta Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02959918's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,547 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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