Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
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
1 other identifier
interventional
152
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 6, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
February 14, 2022
CompletedFebruary 14, 2022
January 1, 2022
2.2 years
November 6, 2016
April 2, 2021
January 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Five monthly infusions
Secondary Outcomes (1)
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
3 and 5 months
Study Arms (14)
SEL-037 Pegadricase LD (low dose) alone
EXPERIMENTALPegadricase 0.2 mg/kg intravenous (IV) every 28 days for 5 treatments
SEL-037 Pegadricase HD (high dose) alone
EXPERIMENTALPegadricase 0.4 mg/kg intravenous (IV) every 28 days for 5 treatments
SEL-212, Pegadricase LD & SEL-110 (1a)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 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)
EXPERIMENTALPegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 5 treatments
Interventions
SEL-212, biologic
SEL-037, biologic
SVP-rapamycin, biologic
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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)
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Tri West Research Associates LLC
El Cajon, California, 92020, United States
Irvine Center for Clinical Research Inc.
Irvine, California, 92614, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Omega Research Consultants LLC
DeBary, Florida, 32713, United States
Compass Research LLC
Orlando, Florida, 32806, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
L-MARC
Louisville, Kentucky, 40213, United States
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Related Publications (1)
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.
PMID: 37069364DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Peter Traber
- Organization
- Selecta Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2016
First Posted
November 9, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
February 14, 2022
Results First Posted
February 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share