Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
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ClinicalTrials.gov Identifier: NCT02959918 |
Recruitment Status :
Completed
First Posted : November 9, 2016
Last Update Posted : April 1, 2019
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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 subjects will be treated with multiple doses( 5 monthly IV infusions) of pegsiticase (SEL-037) alone.
Subjects will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will drawn a pre-determined time points in addition to weekly serum uric acid levels.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gout Chronic Hyperuricemia | Drug: SEL-212 Drug: SEL-037 Drug: SVP-rapamycin (SEL-110) | Phase 2 |
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 subjects 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 subjects 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 subject 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 .
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 152 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 2016 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: SEL-037 Pegsiticase LD(low dose) alone |
Drug: SEL-037
SEL-037, biologic
Other Name: pegsiticase |
Experimental: SEL-037 Pegsiticase HD(high dose) alone |
Drug: SEL-037
SEL-037, biologic
Other Name: pegsiticase |
Experimental: SEL-212, Pegsiticase LD & SEL-110 (1a) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (1b) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase LD & SEL-110 (2a) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (2b) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (3a) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (3b) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (4a) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (4b) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (5a) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (5b) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (6a) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
Experimental: SEL-212, Pegsiticase HD & SEL-110 (6b) |
Drug: SEL-212
SEL-212 Drug: SVP-rapamycin (SEL-110) |
- Safety and tolerability of multiple intravenous infusions of SEL-212 as assessed by the frequency of drug related adverse events, graded by severity [ Time Frame: Five monthly infusions ]To determine the safety and tolerability of 3 monthly infusions of SEL-212 followed by 2 monthly infusions of SEL-037 (pegsiticase) as assessed by frequency of drug related adverse events, graded by severity
- Pharmacokinetics (PK) of SEL-037 (pegsiticase) after multiple monthly IV infusions with or without SEL-110 [ Time Frame: 5 months ]Measurement of the pharmacokinetics of SEL-037, with or without SEL-110, for 30 days after multiple monthly IV infusions by area under the blood concentration versus time curve (AUC)
- Pharmacodynamics (PD) (ability to reduce circulating uric acid) of SEL-037 after multiple monthly IV infusions with or without SEL-110 [ Time Frame: 5 months ]Measurement of the pharmacodynamics (ability to reduce circulating uric acid) of SEL-037 after multiple monthly infusions with or without SEL-110 by measurement of blood uric acid levels for 30 days post infusion
- Immunogenicity of SEL-037 after multiple monthly IV infusions with our without SEL-110 [ Time Frame: 5 months ]Immunogenicity of SEL-037 after multiple monthly IV infusions with or without SEL-110 by measurement of anti-drug antibody levels over 30 days post each infusion
- The pharmacokinetics (PK) of rapamycin after multiple IV infusions of SEL-110 with multiple IV infusions of SEL-037. [ Time Frame: 5 months ]To determine the pharmacokinetics of rapamycin after multiple I V infusions of SEl-212 by area under the blood concentration versus time curve (AUC)
- The effect on uric acid deposits and/or total body uric acid deposited as measured by Dual Energy Computed Tomography scan of multiple doses of SEL-037 alone or multiple doses of SEL-212 plus additional doses of SEL-037. [ Time Frame: Baseline and 5 months ]To measure the change in uric acid deposits in specified joints from beginning to end of treatment

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 >6ng/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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959918
United States, California | |
Anaheim Clinical Trials | |
Anaheim, California, United States, 92801 | |
Tri West Research Associates LLC | |
El Cajon, California, United States, 92020 | |
Irvine Center for Clinical Research Inc. | |
Irvine, California, United States, 92614 | |
United States, Florida | |
Clinical Research of West Florida | |
Clearwater, Florida, United States, 33765 | |
Omega Research Consultants LLC | |
DeBary, Florida, United States, 32713 | |
Compass Research LLC | |
Orlando, Florida, United States, 32806 | |
United States, Hawaii | |
East-West Medical Research Institute | |
Honolulu, Hawaii, United States, 96814 | |
United States, Idaho | |
Advanced Clinical Research | |
Boise, Idaho, United States, 83642 | |
United States, Kentucky | |
L-MARC | |
Louisville, Kentucky, United States, 40213 | |
United States, North Carolina | |
Triad Clinical Trials LLC | |
Greensboro, North Carolina, United States, 27410 | |
United States, Ohio | |
New Horizons Clinical Research | |
Cincinnati, Ohio, United States, 45242 | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Utah | |
Advanced Clinical Research | |
West Jordan, Utah, United States, 84088 |
Responsible Party: | Selecta Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT02959918 |
Other Study ID Numbers: |
SEL-212/201 |
First Posted: | November 9, 2016 Key Record Dates |
Last Update Posted: | April 1, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Gout Hyperuricemia Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |
Pathologic Processes Sirolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |