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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 is a Phase 2 study that has completed, run by Selecta Biosciences. The registered enrollment target is 152 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02959918
The ClinicalTrials.gov registry entry for NCT02959918 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Selecta Biosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which SEL-212 is the first listed.
NCT02959918 reports 0 study locations.
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.
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