CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
SEL-212 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03905512
NCT03905512Phase 2Completed
CompareCT.gov

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy

Selecta Biosciences, Inc.·interventional·Posted Apr 5, 2019·Updated Oct 17, 2023

In Brief

A Phase 2 clinical trial evaluating SEL-212 and KRYSTEXXA® for Chronic Gout. Completed, enrolled 170 participants across 43 sites.

Detailed Summary

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Gout
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 5, 2019
Enrollment StartMay 7, 2019
Primary CompletionAug 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

SEL-212drug

Administered as specified in the treatment arm

KRYSTEXXA®drug

Administered as specified in the treatment arm