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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
Sponsor:
Information provided by (Responsible Party):
Selecta Biosciences, Inc.

Study Description
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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 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

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) 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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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)


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

Inclusion Criteria:

  1. 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. ≥ 1 tophus
    2. 1 gout flare within the last 6 months
    3. Chronic gouty arthropathy
  2. Screening serum uric acid of >6ng/dL
  3. On a gout flare prophylactic regimen for 7 days prior to first dose
  4. Willing to provide written informed consent prior to first study procedure is performed.
  5. Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits.

Exclusion Criteria:

  1. History of anaphylaxis or severe allergic reaction.
  2. History of an allergy to pegylated products.

  3. 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)
  4. 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
  5. Uncontrolled diabetes with baseline HbA1c ≥8%;
  6. Glucose-6-phosphate dehydrogenase deficiency;
  7. Uncontrolled hypertension
  8. Ongoing treatment for arrhythmia, including placement of an implantable defibrillator;
  9. History of coronary artery disease, including myocardial infarction;
  10. Congestive heart failure, New York Heart Association Class III or IV;
  11. 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;
  12. History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
  13. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®), pegsiticase (SEL-037)
  14. History of malignancy within the last 5 years other than basal skin cancer;
  15. Subjects who, in the opinion of the investigator, present with a condition that would compromise their safety or that would make study completion unlikely.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Selecta Biosciences, Inc.
More Information
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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
Additional relevant MeSH terms:
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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