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

Completed · Phase 2

Conditions studied: Gout Chronic, Hyperuricemia

In brief

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.

Key facts

Study ID

NCT02959918

Run by

Selecta Biosciences, Inc.

People needed

152

Starts

2016-10-01

Expected to finish

2019-01-01

Last updated by the study team

2022-02-14

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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)
• 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%;
• 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.

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States
• Tri West Research Associates LLC — El Cajon, California, United States
• Irvine Center for Clinical Research Inc. — Irvine, California, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Omega Research Consultants LLC — DeBary, Florida, United States
• Compass Research LLC — Orlando, Florida, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Advanced Clinical Research — Boise, Idaho, United States
• L-MARC — Louisville, Kentucky, United States
• Triad Clinical Trials LLC — Greensboro, North Carolina, United States
• New Horizons Clinical Research — Cincinnati, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Advanced Clinical Research — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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