Gout ChronicPhase 2NCT02959918

Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid

A Phase 2 study testing SEL-212, SEL-037 and SVP-rapamycin (SEL-110) in people with Gout Chronic and Hyperuricemia, run by Selecta Biosciences, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Gout Chronic, Hyperuricemia
What is being tested?: SEL-212, SEL-037 and SVP-rapamycin (SEL-110)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 13 sitesUnited States
Study dates: Oct 2016to Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult (age 21-75 inclusive) men and women of non child bearing potential with established or symptomatic gout which is defined as having at least ONE of any of the 3 following factors:
≥ 1 tophus
1 gout flare within the last 6 months
Chronic gouty arthropathy
Screening serum uric acid of >6 mg/dL
On a gout flare prophylactic regimen for 7 days prior to first dose
Willing to provide written informed consent prior to first study procedure is performed.
Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits.

Who cannot join

History of anaphylaxis or severe allergic reaction.
History of an allergy to pegylated products.
Women of child bearing potential, Defined as:
<6 weeks after surgical bilateral salpingooperhectony with or without hysterectomy
Pre or perimenopausal ( < less than 24 months of natural amenorrhea)
Initiation or change in dose of hormone-replacement therapy for menopausal women less than 1 month prior to the Screening Visit or during the Screening Phase would be exclusionary. If after being on a stable dose of hormone-replacement therapy for one month the patient may be considered for the study if she continues to meet all other inclusion and exclusion criteria

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Uncontrolled diabetes with baseline HbA1c ≥8%;
Glucose-6-phosphate dehydrogenase deficiency;
Uncontrolled hypertension
Ongoing treatment for arrhythmia, including placement of an implantable defibrillator;
History of coronary artery disease, including myocardial infarction;
Congestive heart failure, New York Heart Association Class III or IV;
ECG with evidence of prior myocardial infarction, clinically significant arrhythmia, or other abnormalities that, in the opinion of the investigator, are consistent with significant underlying cardiac disease;
History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®), pegsiticase (SEL-037)
History of malignancy within the last 5 years other than basal skin cancer;
Subjects who, in the opinion of the investigator, present with a condition that would compromise their safety or that would make study completion unlikely.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Advanced Clinical Research
Boise, Idaho, 83642
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Clinical Research of West Florida
Clearwater, Florida, 33765
Omega Research Consultants LLC
DeBary, Florida, 32713
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Tri West Research Associates LLC
El Cajon, California, 92020
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Irvine Center for Clinical Research Inc.
Irvine, California, 92614
L-MARC
Louisville, Kentucky, 40213
Compass Research LLC
Orlando, Florida, 32806
Advanced Clinical Research
West Jordan, Utah, 84088

Other trials in United States

About this study

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

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.

Read the detailed description

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, also known as pegadricase) 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 participants with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses (5 monthly IV infusions) of pegsiticase (SEL-037) alone.

Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. All participants will be monitored for safety and tolerability to drug throughout the study on a weekly schedule. Pharmacokinetic and pharmacodynamic parameters will at specific timepoints to monitor for continued efficacy. Pharmacodynamic parameters measured include uric acid levels and levels of ADAs.

The study duration per enrolled participant will be approximately 6 months including a 1 month screening period followed by 5 treatment cycles and an end of treatment visit which will occur 30 days after the last IV infusion .

Conditions: Gout Chronic, Hyperuricemia
Being tested: SEL-212, SEL-037, SVP-rapamycin (SEL-110)
Medical subject headings: Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SEL-212Drug
Also called Pegadricase plus SVP-rapamycin
SEL-212, biologic
SEL-037Drug
Also called Pegadricase
SEL-037, biologic
SVP-rapamycin (SEL-110)Drug
Also called SEL-110
SVP-rapamycin, biologic

Study groups in NCT02959918
Study group	Role	What they receive
SEL-037 Pegadricase LD (low dose) alone	Experimental	Pegadricase 0.2 mg/kg intravenous (IV) every 28 days for 5 treatments Receives: Drug: SEL-037
SEL-037 Pegadricase HD (high dose) alone	Experimental	Pegadricase 0.4 mg/kg intravenous (IV) every 28 days for 5 treatments Receives: Drug: SEL-037
SEL-212, Pegadricase LD & SEL-110 (1a)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (1b)	Experimental	Pegadricase 0.4 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase LD & SEL-110 (2a)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (2b)	Experimental	Pegadricase 0.4 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (3a)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (3b)	Experimental	Pegadricase 0.4 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (4a)	Experimental	Pegadricase 0.4 mg/kg IV plus SEL-110 0.125 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (4b)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (5a)	Experimental	Pegadricase 0.4 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (5b)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 5 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (6a)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.10 mg/kg IV every 28 days for 1 treatment followed by pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 4 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (6b)	Experimental	Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 5 treatments Receives: Drug: SEL-212; Drug: SVP-rapamycin (SEL-110)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set
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
Measured: Five monthly infusions

Secondary outcomes (1)

Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA < 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Measured: 3 and 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Jan 2019

First posted9 Nov 2016 (estimated)
Study startOct 2016
Primary completionDec 2018
Study completionJan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gout ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02959918
Sponsor's protocol ID: SEL-212/201
Status last verified: Jan 2022
First submitted: 6 Nov 2016
Last updated: 14 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kivitz A, DeHaan W, Azeem R, Park J, Rhodes S, Inshaw J, Leung SS, Nicolaou S, Johnston L, Kishimoto TK, Traber PG, Sands E, Choi H. Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110). Rheumatol Ther. 2023 Aug;10(4):825-847. doi: 10.1007/s40744-023-00546-0. Epub 2023 Apr 17.
PubMed 37069364

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Maintenance or Withdrawal of Urate Lowering Therapy According to Ultrasound Features in Gout Patients: a Randomised Controlled Trial Stop Treatment In Gout
Gout Chronic

All Gout Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02959918
Acronym / sponsor ID: SEL-212/201
Conditions: Gout Chronic, Hyperuricemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Selecta Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Jan 2019 (actual)
First posted: 9 Nov 2016 (estimated)
Results: Posted 14 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 14

Arm	Type	Receives
SEL-037 Pegadricase LD (low dose) alone	Experimental	Drug: SEL-037Pegadricase 0.2 mg/kg intravenous (IV) every 28 days for 5 treatments
SEL-037 Pegadricase HD (high dose) alone	Experimental	Drug: SEL-037Pegadricase 0.4 mg/kg intravenous (IV) every 28 days for 5 treatments
SEL-212, Pegadricase LD & SEL-110 (1a)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (1b)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.4 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase LD & SEL-110 (2a)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (2b)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.4 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (3a)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (3b)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.4 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (4a)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.4 mg/kg IV plus SEL-110 0.125 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (4b)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (5a)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.4 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
SEL-212, Pegadricase HD & SEL-110 (5b)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 5 treatments
SEL-212, Pegadricase HD & SEL-110 (6a)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.10 mg/kg IV every 28 days for 1 treatment followed by pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 4 treatments
SEL-212, Pegadricase HD & SEL-110 (6b)	Experimental	Drug: SEL-212, Drug: SVP-rapamycin (SEL-110)Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 5 treatments

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Adult (age 21-75 inclusive) men and women of non child bearing potential with established or symptomatic gout which is defined as having at least ONE of any of the 3 following factors:
Screening serum uric acid of >6 mg/dL
On a gout flare prophylactic regimen for 7 days prior to first dose
Willing to provide written informed consent prior to first study procedure is performed.
Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits.

Key exclusion criteria (17 listed)

History of anaphylaxis or severe allergic reaction.
History of an allergy to pegylated products.
Women of child bearing potential, Defined as:
Initiation or change in dose of hormone-replacement therapy for menopausal women less than 1 month prior to the Screening Visit or during the Screening Phase would be exclusionary. If after being on a stable dose of hormone-replacement therapy for one month the patient may be considered for the study if she continues to meet all other inclusion and exclusion criteria
Uncontrolled diabetes with baseline HbA1c ≥8%;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SEL-212Also: Pegadricase plus SVP-rapamycinSEL-212, biologic	Drug	SEL-212, Pegadricase HD & SEL-110 (1b), SEL-212, Pegadricase HD & SEL-110 (2b), SEL-212, Pegadricase HD & SEL-110 (3a), SEL-212, Pegadricase HD & SEL-110 (3b), SEL-212, Pegadricase HD & SEL-110 (4a), SEL-212, Pegadricase HD & SEL-110 (4b), SEL-212, Pegadricase HD & SEL-110 (5a), SEL-212, Pegadricase HD & SEL-110 (5b), SEL-212, Pegadricase HD & SEL-110 (6a), SEL-212, Pegadricase HD & SEL-110 (6b), SEL-212, Pegadricase LD & SEL-110 (1a), SEL-212, Pegadricase LD & SEL-110 (2a)
SEL-037Also: PegadricaseSEL-037, biologic	Drug	SEL-037 Pegadricase HD (high dose) alone, SEL-037 Pegadricase LD (low dose) alone
SVP-rapamycin (SEL-110)Also: SEL-110SVP-rapamycin, biologic	Drug	SEL-212, Pegadricase HD & SEL-110 (1b), SEL-212, Pegadricase HD & SEL-110 (2b), SEL-212, Pegadricase HD & SEL-110 (3a), SEL-212, Pegadricase HD & SEL-110 (3b), SEL-212, Pegadricase HD & SEL-110 (4a), SEL-212, Pegadricase HD & SEL-110 (4b), SEL-212, Pegadricase HD & SEL-110 (5a), SEL-212, Pegadricase HD & SEL-110 (5b), SEL-212, Pegadricase HD & SEL-110 (6a), SEL-212, Pegadricase HD & SEL-110 (6b), SEL-212, Pegadricase LD & SEL-110 (1a), SEL-212, Pegadricase LD & SEL-110 (2a)

Primary outcome

Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set
Time frame: Five monthly infusions
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

1 secondary outcome

Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Time frame: 3 and 5 months

Results and safety

Results posted to the registry on 14 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SEL-037 (Pegadricase) Low Dose	3	0
SEL-037 (Pegadricase) High Dose	3	0
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	9	1
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	10	1
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	6	1
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	11	5
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	11	6
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	12	6
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	14	7
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	13	7
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	14	8
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses	23	11
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low for 4 Doses	11	4
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses	12	6

Primary outcome: Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set

Time frame: Five monthly infusions. Count of participants. Unit: Participants

Measure	SEL-037 (Pegadricase) Low Dose n = 3	SEL-037 (Pegadricase) High Dose n = 3	SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses n = 9	SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses n = 10	SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses n = 6	SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses n = 11	SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses n = 11	SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses n = 12	SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses n = 14	SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses n = 13	SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses n = 14	SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses n = 23	SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses n = 11	SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses n = 12
Value	3	3	9	10	6	11	11	12	14	13	14	23	11	12

Population analysed: Safety analysis set, dosed subjects

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SEL-037 (Pegadricase) Low Dose	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
SEL-037 (Pegadricase) High Dose	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	2 of 9 (22.2%)	8 of 9 (88.9%)	0 of 9
SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	0 of 10 (0%)	8 of 10 (80%)	0 of 10
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	0 of 6 (0%)	6 of 6 (100%)	0 of 6
SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	1 of 11 (9.1%)	10 of 11 (90.9%)	0 of 11
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	2 of 11 (18.2%)	10 of 11 (90.9%)	0 of 11
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	4 of 12 (33.3%)	12 of 12 (100%)	0 of 12
SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	2 of 14 (14.3%)	14 of 14 (100%)	0 of 14
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses	0 of 13 (0%)	12 of 13 (92.3%)	0 of 13
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses	1 of 14 (7.1%)	14 of 14 (100%)	0 of 14
SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses	3 of 23 (13%)	21 of 23 (91.3%)	0 of 23
SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses	1 of 11 (9.1%)	9 of 11 (81.8%)	0 of 11
SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses	2 of 12 (16.7%)	12 of 12 (100%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37069364Kivitz A, DeHaan W, Azeem R, Park J, Rhodes S, Inshaw J, Leung SS, Nicolaou S, Johnston L, Kishimoto TK, Traber PG, Sands E, Choi H. Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110). Rheumatol Ther. 2023 Aug;10(4):825-847. doi: 10.1007/s40744-023-00546-0. Epub 2023 Apr 17.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SEL-212, SEL-037 and SVP-rapamycin (SEL-110) in people with Gout Chronic and Hyperuricemia, run by Selecta Biosciences, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set (time frame: Five monthly infusions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02959918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.