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New monthly shot shows promise for Tough-to-Treat gout

NCT ID NCT04596540

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called SEL-212 for people with chronic gout that doesn't get better with standard treatments. 153 adults received either one of two doses of SEL-212 or a placebo every 28 days for about 6 months. The goal was to see if the drug could lower uric acid levels below a target and keep them there, which may help control gout symptoms.

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

153 people

The number who actually took part.

Started

Nov 2020

Finished

Jan 2023

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: 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. 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 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

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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

  • AIM Trials - Internal Medicine

    Plano, Texas, 75074, United States

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102, Georgia

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Amarillo Center for Clinical Research, Ltd.

    Amarillo, Texas, 79124, United States

  • Arthritis Center of North Georgia, LLC

    Gainesville, Georgia, 30501, United States

  • Arthritis Northwest, PLLC - Research

    Spokane, Washington, 99204, United States

  • Carolina Research Center, Inc

    Shelby, North Carolina, 28150, United States

  • Cherkaska Oblasna likarnia

    Cherkasy, 18009, Ukraine

  • Clinical Hospital Center Bezanisjka Kosa

    Belgrade, 11080, Serbia

  • Clinical Research Of West Florida Incorporated

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606, United States

  • Clinical Rheumatological Hospital #25

    Saint Petersburg, Sankt-Peterburg, 190068, Russia

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • D&H National Research Centers

    Miami, Florida, 33155, United States

  • Elite Clinical Research, LLC

    Jackson, Mississippi, 39202, United States

  • GBOU VPO Orenburg State Medical University

    Orenburg, Orenburg Oblast, 460018, Russia

  • Great Lakes Clinical Trials LLC

    Chicago, Illinois, 60640, United States

  • Great Lakes Clinical Trials at Ravenswood Rheumatology

    Chicago, Illinois, 60640, United States

  • Heritage Rheumatology and Arthritis Care

    Colleyville, Texas, 76034, United States

  • Homestead Associates in Research,Inc

    Miami, Florida, 33032, United States

  • Horizon Clinical Research

    Fayetteville, Georgia, 30214, United States

  • Injury Care Medical Center

    Boise, Idaho, 83713, United States

  • Institute for Rheumatology

    Belgrade, 11000, Serbia

  • Institute for Rheumatology - Rheumatology

    Belgrade, 11000, Serbia

  • Institute for Treatment and Rehabilitation Niska Banja

    Niška Banja, Nišavski Okrug, 18205, Serbia

  • JSC "Evex Hospitals"

    Tbilisi, 0159, Georgia

  • Kyivska klinichna likarnia na

    Kyiv, 03049, Ukraine

  • LTD "The First Medical Center"

    Tbilisi, 0180, Georgia

  • LTD Georgian-Dutch Hospital

    Tbilisi, 0172, Georgia

  • LTD Israeli-Georgian Medical Research Clinic "Helsicore"

    Tbilisi, 0112, Georgia

  • LTD MediClub Georgia

    Tbilisi, 0160, Georgia

  • META Medical Research Institute LLC

    Dayton, Ohio, 45432, United States

  • Medical-sanitary unit #157 - Rheumatology

    Saint Petersburg, Sankt-Peterburg, 196066, Russia

  • Medication Management of Greensboro

    Greensboro, North Carolina, 27408, United States

  • Medychnyi tsentr Tovarystva z

    Zaporizhzhia, Zaporizhzhia Oblast, 69005, Ukraine

  • Military Medical Academy

    Belgrade, 11000, Serbia

  • Napa Research

    Pompano Beach, Florida, 33064, United States

  • Naukovo-Doslidnyi Inst. Reabil

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • New Phase Research and Development

    Knoxville, Tennessee, 37909, United States

  • Omegas Research Consultants LLC

    DeBary, Florida, 32713, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014, United States

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099, United States

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk, Kareliya, Respublika, 185019, Russia

  • Research Institute of Rheumatology n.a. Nasonova

    Moscow, Moscow, 115522, Russia

  • Rutgers- New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Ryazan State Medical University n. a. I.P. Pavlov

    Ryazan, Ryazan Oblast, 390039, Russia

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150, United States

  • Sweet Hope Research Specialty, Inc

    Hialeah, Florida, 33016, United States

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902, United States

  • Tovarystvo z obmezhenoi vidpov

    Kyiv, Kyïv, 02081, Ukraine

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410, United States

  • University Of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Vinnytska Oblasna klinichna likarnia imeni M.I

    Vinnytsia, 21018, Ukraine

More trials for these conditions

Other studies related to the condition(s) this trial covers.