A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy

NCT03905512 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SEL-212/202
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 43

Brief Summary

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

Conditions

Chronic Gout

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time

  The average of the data collected during Month 3 and Month 6 was reported.

  Up to Month 6

Secondary Outcomes (9)

• Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6

  Month 6

• Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6

  Month 6

• Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale

  Baseline to End of Month 3, Baseline to End of Month 6

• QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale

  Baseline to End of Month 3, Baseline to End of Month 6

• QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale

  Baseline to End of Month 3, Baseline to End of Month 6

Study Arms (2)

SEL-212

EXPERIMENTAL

Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions

Drug: SEL-212

KRYSTEXXA

ACTIVE COMPARATOR

IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions

Drug: KRYSTEXXA®

Interventions

SEL-212 DRUG

Administered as specified in the treatment arm

SEL-212

KRYSTEXXA® DRUG

Administered as specified in the treatment arm

Also known as: Pegloticase

KRYSTEXXA

Eligibility Criteria

• Age: 21 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of symptomatic gout defined as:
• ≥ 3 gout flares within 18 months of Screening or
• Presence of ≥ 1 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 non-childbearing potential is defined as:
• \> 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or
• Post-menopausal (\> 24 months of natural amenorrhea)
• Has at the Screening Visit SUA ≥ 7 mg/dL, with chronic refractory gout defined as having failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the medically appropriate dose or for whom these drugs are contraindicated;
• Willing to provide written informed consent prior to the conduct of any study specific procedures;
• Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits

You may not qualify if:

• Prior exposure to any experimental or marketed uricase (e.g., pegloticase \[Krystexxa®\], pegadricase \[SEL-037\], rasburicase \[Elitek, Fasturtec\]);
• History of anaphylaxis or severe allergic reactions to medications;
• History of any allergy to pegylated products
• Drugs known to interact with Rapamune cannot be used during the trial;
• Uncontrolled diabetes;
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• Uncontrolled hypertension;
• Participants whose arrhythmia is unstable on current treatment;
• History of coronary artery disease, including myocardial infarction or unstable angina, within the last 6 months;
• Congestive heart failure;
• History of hematological disorders within 1 year or autoimmune disorders, is immunosuppressed or immunocompromised;
• Has received an inactivated vaccine in the previous 3 months or has received a live virus vaccine in the previous 6 months;
• Is planning to receive any vaccination or live virus vaccination during the study;

Sponsors & Collaborators

• Selecta Biosciences, Inc.: lead

Study Sites (43)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, 85351, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Medvin Clinical Research

Covina, California, 91722, United States

Location

Valerius Medical Group and Research Center of Greater Long Beach, Inc.

Los Alamitos, California, 90720, United States

Location

Arthritis Care and Research Center

Poway, California, 92064, United States

Location

MD Strategies Research Centers

San Diego, California, 92119, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

QPS-Medical Research Assoc LLC

Miami, Florida, 33143, United States

Location

Well Pharma Medical Research Corp.

Miami, Florida, 33143, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Accelerated Enrollment Solutions (AES)

Orlando, Florida, 32806, United States

Location

Rheumatology Associates of Central Florida, PA

Orlando, Florida, 32806, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Advent Health Group Multispecialty at Habana and Bruce B. Downs

Tampa, Florida, 33614, United States

Location

Arthritis Center of North Georgia

Gainesville, Georgia, 30501, 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

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

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

Cumberland, Maryland, 21502, United States

Location

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

Hagerstown, Maryland, 21740, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Elite Clinical Research, LLC

Jackson, Mississippi, 39202, United States

Location

TEST

Blue Springs, Missouri, 64014, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cape Fear Arthritis Care PLLC

Leland, North Carolina, 28451, United States

Location

Cape Fear Arthritis Care PLLC

Leland, North Carolina, 28541, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Arthritis & Rheumatology Center of Oklamhoma, PLLC

Oklahoma City, Oklahoma, 73102, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, 19610, United States

Location

West Tennessee Research Institute, LLC

Jackson, Tennessee, 38305, United States

Location

Amarillo Center for Clinical Research

Amarillo, Texas, 79124, United States

Location

Austin Regional Clinic

Austin, Texas, 78731, United States

Location

Tekton Research

Austin, Texas, 78745, 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

Related Publications (1)

• Baraf HSB, Khanna PP, Kivitz AJ, Strand V, Choi HK, Terkeltaub R, Dalbeth N, DeHaan W, Azeem R, Traber PG, Keenan RT. The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR) versus pegloticase for refractory gout. Rheumatology (Oxford). 2024 Apr 2;63(4):1058-1067. doi: 10.1093/rheumatology/kead333.

  PMID: 37449908 DERIVED

MeSH Terms

Interventions

Pegloticase

Results Point of Contact

• Title: Study Director
• Organization: Selecta Biosciences, Inc.

ptraber@selectabio.com

617-923-1400

Study Officials

• Medical Director

  Selecta Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Assessments of qualitative endpoints will be conducted on an assessor-blinded basis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 5, 2019
• Study Start: May 7, 2019
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: October 17, 2023
• Results First Posted: October 17, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (43)