Phase 2
N=152
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Gout Chronic · Hyperuricemia
Bottom Line
View on ClinicalTrials.gov: NCT02959918 ↗Enrolled (actual)
152
Serious AEs
13.2%
Results posted
Feb 2022
Primary outcome: Primary: 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 — 3; 3; 9; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SEL-212 (Drug); SEL-037 (Drug); SVP-rapamycin (SEL-110) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Selecta Biosciences, Inc.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
3; 3; 9; 10; 6; 11 | — |
| SECONDARY Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 |
0; 0; 2; 1; 4; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02959918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.