A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II

Study Purpose

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. Approximately 105 patients, stratified as to the presence or absence of tophi, will be randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial (SEL-212/301 and SEL-212/302). Analysis of efficacy will be performed at Day 28 of Treatment Period 6. Safety will be monitored throughout the study.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Has negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for detection of SARS-CoV-2 RNA from a respiratory specimen; 2. History of symptomatic gout defined as: 1. ≥ 3 gout flares within 18 months of Screening or. 2. Presence of ≥ 1 gout tophus or. 3. Current diagnosis of gouty arthritis. 3. At the Screening Visit: male age 21
  • - 80 years, inclusive, or female of non-childbearing potential age 21-80 years, inclusive, where nonchildbearing potential is defined as: 1.
> 6 weeks after hysterectomy with or without surgical bilateral salpingo-oophorectomy or. 2. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24 months of amenorrhea, one documented confirmatory FSH measurement) 4. Has chronic refractory gout defined as having failed to normalize sUA and whose signs and symptoms are inadequately controlled with any of the xanthine oxidase inhibitors, or for whom these drugs are contraindicated for the patient; 5. Has at the Screening Visit SUA ≥ 7 mg/dL. 6. Negative serology for HIV-1/-2 and negative antigen to hepatitis B and negative antibodies to hepatitis C;

Exclusion Criteria:

1. Has a history of anaphylaxis, severe allergic reactions, or severe atopy; 2. Has a history of any allergy to pegylated products, including, but not limited to pegloticase (Krystexxa®), peginterferon alfa-2a (Pegasys®), peginterferon alfa-2b (PegIntron®), pegfilgrastim (Neulasta®), pegaptanib (Macugen®), pegaspargase (Oncaspar®), pegademase (Adagen®), peg-epoetin beta (Mircera®), pegvisomant (Somavert®) certolizumab pegol (Cimzia®), naloxegol (Movantik®), peginesatide (Omontys®), and doxorubicin liposome (Doxil®); 3. Is taking and cannot discontinue known major CYP3A4/P-gp inhibitors or major CYP3A4/P-gp inducers at least 14 days before dosing. Patients must remain off these medications for the duration of the study, including natural products such as St. John's Wort or grapefruit juice. 4. Is taking drugs known to interact with rapamycin (sirolimus
  • - Rapamune®) such as cyclosporine, diltiazem, erythromycin, ketoconazole, posaconazole, voriconazole, itraconazole, rifampin, verapamil unless they are stopped 14 days prior to dosing and will not be used/prescribed during the trial.
5. Is a post-menopausal woman that has initiated or had a change in dose of hormone replacement therapy (HRT) less than 1 month prior to the Screening Visit or during the Screening Phase. 6. Had a gout flare during Screening that was resolved for less than 1 week prior to first treatment with study drug (exclusive of chronic synovitis/arthritis) unless the patient has a history of inter-flare intervals of < 1 week. 7. Has uncontrolled diabetes at Screening with HbA1c ≥ 8.5%; 8. Has fasting Screening glucose > 240 mg/dL; 9. Has fasting Screening triglyceride > 500 mg/dL; 10. Has fasting Screening low-density lipoprotein (LDL) > 200 mg/dL; 11. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency; 12. Has uncontrolled hypertension defined as blood pressure > 170/100 mmHg at Screening and 1 week prior to dosing. 13. Individual laboratory values which are exclusionary.
  • - White blood cell count (WBC) < 3.0 x109/L.
  • - Serum aspartate aminotransferase (AST) or alanine amino transferase (ALT) > 3x upper limit of normal (ULN) in the absence of known active liver disease.
  • - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
  • - Urine albumin creatinine ratio (UACR) > 3.0.
  • - Hemoglobin (Hgb) < 9 g/dL.
  • - Serum phosphate < 2.0 mg/dL.
14. Is receiving ongoing treatment for arrhythmia, including placement of an implantable defibrillator, unless considered stable and on active treatment; 15. Has evidence of unstable cardiovascular disease or unstable cerebrovascular vascular disease. This includes patients who have had a cardiac/vascular event(s) in the last 3 months including heart attack, stroke or vascular bypass surgery or patients who are deemed, by their physician or PI, to have active cardiovascular, cerebrovascular or peripheral vascular symptoms/disease inadequately controlled by medication; 16. Has congestive heart failure, New York Heart Association Class III or IV; 17. Unless clinically stable and/or appropriately treated, electrocardiogram (ECG) with evidence of clinically significant arrhythmia or other abnormalities that, in the opinion of the investigator, are consistent with significant underlying cardiac disease; 18. History of significant hematological disorders within 5 years or autoimmune disorders, and/or patient is currently immunosuppressed or immunocompromised; 19. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®®), pegadricase (SEL 037)) 20. Patient has received a live vaccine in the previous 6 months. 21. Patient is planning to receive any live vaccine during the study. 22. History of malignancy within the last 5 years other than basal skin cancer; 23. Patients with a documented history of moderate or severe alcohol or substance use disorder within the 12 months prior to randomization. 24. History of or evidence of clinically severe interstitial lung disease. 25. Immunocompromised state, regardless of etiology

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04596540
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Selecta Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Georgia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Gout
Additional Details

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. Approximately 105 patients, stratified as to the presence or absence of tophi, will be randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial (SEL-212/301 and SEL-212/302). The SEL-212 doses will differ as to the SEL-110.36 component. Participants will receive SEL-037 administered at a dose of 0.2 mg/kg via intravenous (IV) infusion immediately after receiving SEL-110.36 at a dose of either 0.1 mg/kg (SEL-212A) or 0.15 mg/kg (SEL-212B) via IV infusion. The placebo will consist of normal saline. Placebo subjects who complete the study will be offered enrollment in an open-label extension study for treatment with SEL-212 (SEL-212/303). Efficacy assessments will be conducted at intervals that are appropriate to determine treatment effect with samples for the primary endpoint drawn during Treatment Period 6. Safety will be monitored throughout the study with an independent data safety monitoring board (DSMB).

Arms & Interventions

Arms

Experimental: SEL-212A

IV infusion of SEL-212A every 28 days for a total of up to 12 infusions

Experimental: SEL-212B

IV infusion of SEL-212B every 28 days for a total of up to 12 infusions

Placebo Comparator: Placebo

IV infusion of Normal Saline every 28 days for a total of up to 12 infusions

Interventions

Drug: - SEL-212A

SEL-212A Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.1 mg/kg) Other Names: SEL-110, ImmTOR

Drug: - SEL-212B

SEL-212B Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.15 mg/kg) Other Names: SEL-110, ImmTOR

Other: - Placebo

Normal saline

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

D&H National Research Centers, Miami, Florida

Status

Recruiting

Address

D&H National Research Centers

Miami, Florida, 33155

Site Contact

Grether Rodriguez

[email protected]

786-375-6210

Napa Research, Pompano Beach, Florida

Status

Recruiting

Address

Napa Research

Pompano Beach, Florida, 33064

Site Contact

Jhonny Bonilla

[email protected]

954-773-9889

Arthritis Center of North Georgia, LLC, Gainesville, Georgia

Status

Recruiting

Address

Arthritis Center of North Georgia, LLC

Gainesville, Georgia, 30501

Site Contact

Laura Corn

[email protected]

678-677-8824

Injury Care Medical Center, Boise, Idaho

Status

Recruiting

Address

Injury Care Medical Center

Boise, Idaho, 83713

Site Contact

Bridget Venard

[email protected]

208-939-2100

Chicago, Illinois

Status

Recruiting

Address

Great Lakes Clinical Trials at Ravenswood Rheumatology

Chicago, Illinois, 60640

Site Contact

Zander Schrempp

[email protected]

773-275-3500

Great Lakes Clinical Trials LLC, Chicago, Illinois

Status

Recruiting

Address

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60640

Site Contact

Jim Miedema

[email protected]

773-275-3500

Wheaton, Maryland

Status

Recruiting

Address

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902

Site Contact

Megan Lormore

[email protected]

301-942-6610

Triad Clinical Trials, Greensboro, North Carolina

Status

Recruiting

Address

Triad Clinical Trials

Greensboro, North Carolina, 27410

Site Contact

Shavonna Haamid

[email protected]

336-235-0991

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Site Contact

Lisa Claycomb

[email protected]

814-693-0300 #124

Amarillo, Texas

Status

Recruiting

Address

Amarillo Center for Clinical Research, Ltd.

Amarillo, Texas, 79124

Site Contact

Casey Mizer

[email protected]

806-352-2453

Heritage Rheumatology and Arthritis Care, Colleyville, Texas

Status

Recruiting

Address

Heritage Rheumatology and Arthritis Care

Colleyville, Texas, 76034

Site Contact

Chudi Nwoye

[email protected]

972-299-8399

Arthritis Northwest, PLLC - Research, Spokane, Washington

Status

Recruiting

Address

Arthritis Northwest, PLLC - Research

Spokane, Washington, 99204

Site Contact

Seinna Gray

[email protected]

509-838-6500 #320

International Sites

Tbilisi, Georgia

Status

Recruiting

Address

LTD Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, , 0112

Site Contact

Ketevan Gabunia, MD

[email protected]

995 599 577 977

JSC "Evex Hospitals", Tbilisi, Georgia

Status

Recruiting

Address

JSC "Evex Hospitals"

Tbilisi, , 0159

Site Contact

Nina Tskhovrebashvili, MD

[email protected]

+995599147085

LTD MediClub Georgia, Tbilisi, Georgia

Status

Recruiting

Address

LTD MediClub Georgia

Tbilisi, , 0160

Site Contact

David Gochitashvili

[email protected]

+995599510806

LTD "The First Medical Center", Tbilisi, Georgia

Status

Recruiting

Address

LTD "The First Medical Center"

Tbilisi, , 0180

Site Contact

Besik Tsintsadze

[email protected]

+995 558 100 725