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PEGylated Uricase Enzyme

SEL-212 low-dose for Gout (DISSOLVE I Trial)

Phase 3
Waitlist Available
Research Sponsored by Swedish Orphan Biovitrum
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

DISSOLVE I Trial Summary

This trial is testing a new drug, SEL-212, to see if it is safe and effective for treating gout. 120 patients will be given the drug or a placebo every 28 days for 6 months to see if there are any improvements.

Eligible Conditions
  • Gout

DISSOLVE I Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum uric acid control during month 6
Secondary outcome measures
Gout Flare Incidence
HAQ-DI
Percent reduction of mean serum uric acid
+5 more

DISSOLVE I Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SEL-212 low-doseExperimental Treatment1 Intervention
SEL-212 low-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.1 mg/kg) SEL-110.36, ImmTOR
Group II: SEL-212 high-doseExperimental Treatment1 Intervention
SEL-212 high-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.15 mg/kg) SEL-110.36, ImmTOR
Group III: PlaceboPlacebo Group1 Intervention
Normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEL-212 low-dose
2020
Completed Phase 3
~270
SEL-212 high-dose
2020
Completed Phase 3
~270

Find a Location

Who is running the clinical trial?

Swedish Orphan BiovitrumLead Sponsor
92 Previous Clinical Trials
12,402 Total Patients Enrolled
1 Trials studying Gout
153 Patients Enrolled for Gout
Selecta Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
720 Total Patients Enrolled
5 Trials studying Gout
560 Patients Enrolled for Gout

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New Jersey
Florida
How old are they?
18 - 65
What site did they apply to?
Medex Healthcare Research, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Medex Healthcare Research, Inc.: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
2020. "A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04513366.
~24 spots leftby Apr 2025
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