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

NCT04596540 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: SEL-212/3022020-003070-45
• Study Type: interventional
• Target: 153
• Locations: 5 countries
• Sites: 53

Brief Summary

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. 112 and 153 patients, stratified as to the presence or absence of tophi, were 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 respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

Conditions

Chronic Gout

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Achieved and Maintained Reduction in Serum Uric Acid (sUA) < 6 Milligrams Per Deciliter (mg/dL) for At Least 80% of The Time During Treatment Period 6 (Month 6)

  Month 6

Secondary Outcomes (9)

• Change From Baseline in Mean sUA

  Baseline up to 6 months

• Percentage Change From Baseline in Mean sUA

  Baseline up to 6 months

• Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36)

  Baseline up to 6 months

• Proportion of Participants With at Least Partial Response (PR) (as Best Response) in Overall Tophus Response Evaluation in Participants With Tophi at Baseline

  Baseline Up to 6 months

• Proportion of Participants Who Achieved and Maintained Reduction of sUA < 6 mg/dL for at Least 80% of the Time During Month 6 in the Subset of Participants With Tophi at Baseline

  Baseline up to 6 months

Study Arms (3)

SEL-212 low-dose

EXPERIMENTAL

IV infusion of SEL-212 low-dose every 28 days for a total of up to 6 infusions

Drug: SEL-212 low-dose

SEL-212 high-dose

EXPERIMENTAL

IV infusion of SEL-212 high-dose every 28 days for a total of up to 6 infusions

Drug: SEL-212 high-dose

Placebo

PLACEBO COMPARATOR

IV infusion of Normal Saline every 28 days for a total of up to 6 infusions

Other: Placebo

Interventions

SEL-212 low-dose DRUG

SEL-212 low-dose 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

SEL-212 low-dose

SEL-212 high-dose DRUG

SEL-212 high-dose 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

SEL-212 high-dose

Placebo OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Gender Eligibility Details: female of non-childbearing potential defined as either \>6 weeks after hysterectomy with or without surgical bilateral salpingo-oophorectomy OR post-menopausal (\> 24 months of natural amenorrhea or in the absence of \> 24 months of amenorrhea, one documented confirmatory FSH measurement)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• History of symptomatic gout defined as:
• ≥ 3 gout flares within 18 months of Screening or
• Presence of ≥ 1 gout tophus or
• Current diagnosis of gouty arthritis
• 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:
• \> 6 weeks after hysterectomy with or without surgical bilateral salpingo-oophorectomy or
• Post-menopausal (\> 24 months of natural amenorrhea or in the absence of \>24 months of amenorrhea, one documented confirmatory FSH measurement)
• 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;
• Has at the Screening Visit SUA ≥ 7 mg/dL
• Negative serology for HIV-1/-2 and negative antigen to hepatitis B and negative antibodies to hepatitis C;

You may not qualify if:

• Has a history of anaphylaxis, severe allergic reactions, or severe atopy;
• 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®);
• 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.
• 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.
• Had major surgery within 3 months of initial screening.
• 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.
• Has uncontrolled diabetes at Screening with HbA1c ≥ 8.5%;
• Has fasting Screening glucose \> 240 mg/dL;
• Has fasting Screening triglyceride \> 500 mg/dL;
• Has fasting Screening low-density lipoprotein (LDL) \> 200 mg/dL;
• Has glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• Has uncontrolled hypertension defined as blood pressure \> 170/100 mmHg at Screening and 1 week prior to dosing
• 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

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead

Study Sites (53)

Clinical Research Of West Florida Incorporated

Clearwater, Florida, 33765, United States

Location

Omegas Research Consultants LLC

DeBary, Florida, 32713, United States

Location

Sweet Hope Research Specialty, Inc

Hialeah, Florida, 33016, United States

Location

Homestead Associates in Research,Inc

Miami, Florida, 33032, United States

Location

D&H National Research Centers

Miami, Florida, 33155, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Napa Research

Pompano Beach, Florida, 33064, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Horizon Clinical Research

Fayetteville, Georgia, 30214, United States

Location

Arthritis Center of North Georgia, LLC

Gainesville, Georgia, 30501, United States

Location

Injury Care Medical Center

Boise, Idaho, 83713, United States

Location

Great Lakes Clinical Trials at Ravenswood Rheumatology

Chicago, Illinois, 60640, United States

Location

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60640, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Elite Clinical Research, LLC

Jackson, Mississippi, 39202, United States

Location

Rutgers- New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Medication Management of Greensboro

Greensboro, North Carolina, 27408, United States

Location

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

Location

Carolina Research Center, Inc

Shelby, North Carolina, 28150, United States

Location

META Medical Research Institute LLC

Dayton, Ohio, 45432, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

New Phase Research and Development

Knoxville, Tennessee, 37909, United States

Location

Amarillo Center for Clinical Research, Ltd.

Amarillo, Texas, 79124, United States

Location

Heritage Rheumatology and Arthritis Care

Colleyville, Texas, 76034, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States

Location

AIM Trials - Internal Medicine

Plano, Texas, 75074, United States

Location

Arthritis Northwest, PLLC - Research

Spokane, Washington, 99204, United States

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

Location

LTD Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, 0112, Georgia

Location

JSC "Evex Hospitals"

Tbilisi, 0159, Georgia

Location

LTD MediClub Georgia

Tbilisi, 0160, Georgia

Location

LTD Georgian-Dutch Hospital

Tbilisi, 0172, Georgia

Location

LTD "The First Medical Center"

Tbilisi, 0180, Georgia

Location

Republican Hospital n.a. V.A. Baranov

Petrozavodsk, Kareliya, Respublika, 185019, Russia

Location

Research Institute of Rheumatology n.a. Nasonova

Moscow, Moscow, 115522, Russia

Location

GBOU VPO Orenburg State Medical University

Orenburg, Orenburg Oblast, 460018, Russia

Location

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

Ryazan, Ryazan Oblast, 390039, Russia

Location

Clinical Rheumatological Hospital #25

Saint Petersburg, Sankt-Peterburg, 190068, Russia

Location

Medical-sanitary unit #157 - Rheumatology

Saint Petersburg, Sankt-Peterburg, 196066, Russia

Location

Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, Nišavski Okrug, 18205, Serbia

Location

Institute for Rheumatology - Rheumatology

Belgrade, 11000, Serbia

Location

Institute for Rheumatology

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanisjka Kosa

Belgrade, 11080, Serbia

Location

Tovarystvo z obmezhenoi vidpov

Kyiv, Kyïv, 02081, Ukraine

Location

Naukovo-Doslidnyi Inst. Reabil

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

Medychnyi tsentr Tovarystva z

Zaporizhzhia, Zaporizhzhia Oblast, 69005, Ukraine

Location

Cherkaska Oblasna likarnia

Cherkasy, 18009, Ukraine

Location

Kyivska klinichna likarnia na

Kyiv, 03049, Ukraine

Location

Vinnytska Oblasna klinichna likarnia imeni M.I

Vinnytsia, 21018, Ukraine

Location

Results Point of Contact

• Title: Blank Clinical Study Physician, MD
• Organization: Swedish Orphan Biovitrum AB (publ)

medical.info@sobi.com

+46 8 697 20 00

Study Officials

• Medical Director

  Swedish Orphan Biovitrum AB (publ)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: November 30, 2020
• Primary Completion: January 10, 2023
• Study Completion: January 12, 2023
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (30); SE (5); RU (6); UA (6); GE (6)