New infusion drug shows promise for stubborn gout

NCT ID NCT04513366

Disease control Sponsor: Swedish Orphan Biovitrum Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a drug called SEL-212 in 112 adults with chronic gout that didn't improve with standard treatments. Participants received either a low or high dose of SEL-212 or a placebo by IV infusion every 28 days for about 6 months. The main goal was to see if the drug could lower uric acid levels below 6 mg/dL for most of the sixth month. Researchers also tracked gout flares and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: SEL-212 (a drug given by IV infusion to lower uric acid levels)
What this could lead to: If it works, this could offer a new treatment option for people with chronic gout that doesn't respond to standard pills.
What could go wrong: This is a completed Phase 3 trial, but results may not apply to all gout patients. The drug requires regular IV infusions and may have side effects like infusion reactions or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

112 people

The number who actually took part.

Started

Aug 2020

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 nasal or oropharyngeal 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. Had major surgery within 3 months of initial screening. 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) \> 30 mg/g * 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 37)) 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

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic gout

Contacts and locations

Locations

ACRC Studies

Poway, California, 92064, United States
AIM Trials - Internal Medicine

Plano, Texas, 75234, United States
Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian

Meridian, Idaho, 83642, United States
Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, 85351, United States
Arthritis & Rheumatology Center of Oklahoma, PLLC

Oklahoma City, Oklahoma, 73102, United States
Arthritis Consultants, Inc.

St Louis, Missouri, 63141, United States
Better Health Clinical Research, Inc.

Newnan, Georgia, 30265, United States
CFA - Cape Fear Arthritis Care, PLLC

Leland, North Carolina, 28451, United States
Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States
Clinical Research Of West Florida Incorporated

Clearwater, Florida, 33765, United States
Clinical Research Partners, LLC

Richmond, Virginia, 23220, United States
Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States
Conquest Research

Winter Park, Florida, 32789, United States
Elite Clinical Research, LLC

Jackson, Mississippi, 39216, United States
Epic Medical Research

Red Oak, Texas, 75154, United States
Health Awareness INC

Jupiter, Florida, 33458, United States
Helix Biomedics, LLC

Boynton Beach, Florida, 33435, United States
Homestead Associates in Research,Inc

Homestead, Florida, 33032, United States
Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States
Klein and Associates, M.D., P.A.

Cumberland, Maryland, 21502, United States
Klein and Associates, M.D., P.A.

Hagerstown, Maryland, 21740, United States
L-MARC Research Center

Louisville, Kentucky, 40213, United States
MD Strategies Research Center

San Diego, California, 92119, United States
Medex Healthcare Research, Inc.

New York, New York, 10036, United States
Medvin Clinical Research

Covina, California, 91722, United States
Metroplex Clinical Research Center

Dallas, Texas, 75231, United States
Montana Medical Research, Inc.

Missoula, Montana, 59808, United States
New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States
Omegas Research Consultants LLC

DeBary, Florida, 32713, United States
Panax Clinical Research

Miami Lakes, Florida, 33014, United States
Pinnacle Research Group

Anniston, Alabama, 36207, United States
Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States
Research Integrity, LLC

Owensboro, Kentucky, 42303, United States
Riverside Clinical Research

Edgewater, Florida, 32132, United States
Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States
Tekton Research - Fort Collins

Fort Collins, Colorado, 80528, United States
Valerius Medical Group & Research Center

Los Alamitos, California, 90720, United States
Well Pharma Medical Research, Corp

Miami, Florida, 33173, United States
West Tennessee Research Institute

Jackson, Tennessee, 38305, United States
Y & L Advance Health Care, Inc

Miami, Florida, 33144, United States

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