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

NCT04513366 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SEL-212/301
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 40

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 was 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

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) SEL-110.36, ImmTOR

Drug: SEL-212 low-dose

SEL-212 high-dose

EXPERIMENTAL

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) SEL-110.36, ImmTOR

Drug: SEL-212 high-dose

Placebo

PLACEBO COMPARATOR

Normal saline

Other: Normal Saline

Interventions

SEL-212 low-dose DRUG

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

SEL-212 low-dose

SEL-212 high-dose DRUG

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

SEL-212 high-dose

Normal Saline OTHER

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

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:
• 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)
• 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 (40)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, 85351, United States

Location

Medvin Clinical Research

Covina, California, 91722, United States

Location

Valerius Medical Group & Research Center

Los Alamitos, California, 90720, United States

Location

ACRC Studies

Poway, California, 92064, United States

Location

MD Strategies Research Center

San Diego, California, 92119, United States

Location

Tekton Research - Fort Collins

Fort Collins, Colorado, 80528, United States

Location

Helix Biomedics, LLC

Boynton Beach, Florida, 33435, United States

Location

Clinical Research Of West Florida Incorporated

Clearwater, Florida, 33765, United States

Location

Omegas Research Consultants LLC

DeBary, Florida, 32713, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

Homestead Associates in Research,Inc

Homestead, Florida, 33032, United States

Location

Health Awareness INC

Jupiter, Florida, 33458, United States

Location

Y & L Advance Health Care, Inc

Miami, Florida, 33144, United States

Location

Well Pharma Medical Research, Corp

Miami, Florida, 33173, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Better Health Clinical Research, Inc.

Newnan, Georgia, 30265, United States

Location

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

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

Meridian, Idaho, 83642, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

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

Cumberland, Maryland, 21502, United States

Location

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

Hagerstown, Maryland, 21740, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Elite Clinical Research, LLC

Jackson, Mississippi, 39216, United States

Location

Arthritis Consultants, Inc.

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Medex Healthcare Research, Inc.

New York, New York, 10036, United States

Location

CFA - Cape Fear Arthritis Care, PLLC

Leland, North Carolina, 28451, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Arthritis & Rheumatology Center of Oklahoma, PLLC

Oklahoma City, Oklahoma, 73102, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, 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, 75234, United States

Location

Epic Medical Research

Red Oak, Texas, 75154, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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

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: August 7, 2020
• First Posted: August 14, 2020
• Study Start: August 18, 2020
• Primary Completion: July 21, 2022
• Study Completion: December 1, 2022
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Locations

US (40)