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

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: a.
> 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or b. 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.

NCT04513366
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 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. Upon completion of the 6-month double-blinded, placebo-controlled portion of the study, SEL-212/301 will continue in a blinded, placebo-controlled 6-month extension. This will provide up to 12 months of continuous treatment with SEL-212 in a placebo controlled fashion. Subjects who complete both phases of 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

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) SEL-110.36, ImmTOR

Experimental: 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) SEL-110.36, ImmTOR

Placebo Comparator: Placebo

Normal saline

Interventions

Drug: - SEL-212A

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

Drug: - SEL-212B

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

Other: - Normal Saline

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

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.

Pinnacle Research Group, Anniston, Alabama

Status

Recruiting

Address

Pinnacle Research Group

Anniston, Alabama, 36207

Site Contact

Darin Sims

[email protected]

256-236-0055 #101

Sun City, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, 85351

Site Contact

Jenell Halvorson

[email protected]

602-386-4972

Medvin Clinical Research, Covina, California

Status

Recruiting

Address

Medvin Clinical Research

Covina, California, 91722

Site Contact

Lupe Perez

[email protected]

626-869-5730

Valerius Medical Group & Research Center, Los Alamitos, California

Status

Recruiting

Address

Valerius Medical Group & Research Center

Los Alamitos, California, 90720

Site Contact

Michelle Pratt

[email protected]

562-794-9801

ACRC Studies, Poway, California

Status

Recruiting

Address

ACRC Studies

Poway, California, 92064

Site Contact

Janette Ellis

[email protected]

858-227-0915

MD Strategies Research Center, San Diego, California

Status

Recruiting

Address

MD Strategies Research Center

San Diego, California, 92119

Site Contact

Meana Rasheed

[email protected]

619-303-3698 #113

Tekton Research - Fort Collins, Fort Collins, Colorado

Status

Recruiting

Address

Tekton Research - Fort Collins

Fort Collins, Colorado, 80528

Site Contact

Emily Guingrich

[email protected]

970-267-9799

Clearwater, Florida

Status

Recruiting

Address

Clinical Research Of West Florida Incorporated

Clearwater, Florida, 33765

Site Contact

Maartje Brucculeri

[email protected]

727-466-0078

Omegas Research Consultants LLC, DeBary, Florida

Status

Recruiting

Address

Omegas Research Consultants LLC

DeBary, Florida, 32713

Site Contact

Rochelle Parker

[email protected]

386-668-4202

Health Awareness INC, Jupiter, Florida

Status

Recruiting

Address

Health Awareness INC

Jupiter, Florida, 33458

Site Contact

Raelynn Harris

r[email protected]

561-741-2033

Panax Clinical Research, Miami Lakes, Florida

Status

Recruiting

Address

Panax Clinical Research

Miami Lakes, Florida, 33014

Site Contact

Francisca Santana

[email protected]

305-698-4500

Well Pharma Medical Research, Corp, Miami, Florida

Status

Recruiting

Address

Well Pharma Medical Research, Corp

Miami, Florida, 33173

Site Contact

Claudia Restrepo

[email protected]

305-665-4818

Clinical Research of West Florida, Inc., Tampa, Florida

Status

Recruiting

Address

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606

Site Contact

Barbara Keskiner

[email protected]

813-870-1292 #122

Conquest Research, Winter Park, Florida

Status

Recruiting

Address

Conquest Research

Winter Park, Florida, 32789

Site Contact

Mark Daley

[email protected]

407-848-3848

Better Health Clinical Research, Inc., Newnan, Georgia

Status

Recruiting

Address

Better Health Clinical Research, Inc.

Newnan, Georgia, 30265

Site Contact

Debra Helton

[email protected]

770-252-7562

Institute of Arthritis Research, Idaho Falls, Idaho

Status

Recruiting

Address

Institute of Arthritis Research

Idaho Falls, Idaho, 83404

Site Contact

Joann Barry

[email protected]

208-542-9080 #106

Meridian, Idaho

Status

Recruiting

Address

Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian

Meridian, Idaho, 83642

Site Contact

Jammie Smith

[email protected]

208-377-8653 #187

L-MARC Research Center, Louisville, Kentucky

Status

Recruiting

Address

L-MARC Research Center

Louisville, Kentucky, 40213

Site Contact

Coury Hobbs

[email protected]

502-214-3955

Reseach Integrity, LLC, Owensboro, Kentucky

Status

Recruiting

Address

Reseach Integrity, LLC

Owensboro, Kentucky, 42303

Site Contact

Katie Davis

[email protected]

270-691-1827

Klein and Associates, M.D., P.A., Hagerstown, Maryland

Status

Recruiting

Address

Klein and Associates, M.D., P.A.

Hagerstown, Maryland, 21740

Site Contact

Katie Alvord

[email protected]

301-791-6680

Clinical Pharmacology Study Group, Worcester, Massachusetts

Status

Recruiting

Address

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605

Site Contact

Mary Coughlin

[email protected]

508-755-0201

Elite Clinical Research, LLC, Jackson, Mississippi

Status

Recruiting

Address

Elite Clinical Research, LLC

Jackson, Mississippi, 39216

Site Contact

Candy Thomas

[email protected]

601-714-3267

Arthritis Consultants, Inc., Saint Louis, Missouri

Status

Recruiting

Address

Arthritis Consultants, Inc.

Saint Louis, Missouri, 63141

Site Contact

Kelly Spiller

[email protected]

314-567-5100 #21

Montana Medical Research, Inc., Missoula, Montana

Status

Recruiting

Address

Montana Medical Research, Inc.

Missoula, Montana, 59808

Site Contact

Dillon McLeod

[email protected]

406-549-1124

Medex Healthcare Research, Inc., New York, New York

Status

Recruiting

Address

Medex Healthcare Research, Inc.

New York, New York, 10036

Site Contact

Maiya Brown

[email protected]

646-722-6214

Rochester, New York

Status

Recruiting

Address

Finger Lakes Clincal Research - Inf. Disease/Infectiology

Rochester, New York, 14618

Site Contact

Sanoelani-Lindsey Lanias

[email protected]

585-241-9670

CFA - Cape Fear Arthritis Care, PLLC, Leland, North Carolina

Status

Recruiting

Address

CFA - Cape Fear Arthritis Care, PLLC

Leland, North Carolina, 28451

Site Contact

Cassie Snow

[email protected]

910-726-1806

New Horizons Clinical Research, Cincinnati, Ohio

Status

Recruiting

Address

New Horizons Clinical Research

Cincinnati, Ohio, 45242

Site Contact

Mylene Asmar-Rios

[email protected]

513-769-2767 #157

West Tennessee Research Institute, Jackson, Tennessee

Status

Recruiting

Address

West Tennessee Research Institute

Jackson, Tennessee, 38305

Site Contact

Sherry Wiggins

[email protected]

731-633-0045

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

Site Contact

Paul Hernandez

[email protected]

214-879-6737 #1407

Pioneer Research Solutions, Inc., Houston, Texas

Status

Recruiting

Address

Pioneer Research Solutions, Inc.

Houston, Texas, 77099

Site Contact

Billal Mallick

[email protected]

713-333-9323

Southwest Rheumatology Research LLC, Mesquite, Texas

Status

Recruiting

Address

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150

Site Contact

Guadalupe Cindo

[email protected]

972-288-2600

Clinical Research Partners, LLC, Richmond, Virginia

Status

Recruiting

Address

Clinical Research Partners, LLC

Richmond, Virginia, 23220

Site Contact

Prechus Taylor

[email protected]

804-477-3045