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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Gout
• Intervention / Treatment: Drug: SEL-212; Drug: KRYSTEXXA®

Detailed Description

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 [a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)] or KRYSTEXXA® for 6 months.

Study participants in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study participants in the KRYSTEXXA® arm will receive study drug according to the manufacturer's prescribing information, i.e., every 14 days for a total of up to 12 infusions of KRYSTEXXA®.

Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Arizona Arthritis & Rheumatology Research, PLLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research
    • Los Alamitos, California, United States, 90720
      • Valerius Medical Group and Research Center of Greater Long Beach, Inc.
    • Poway, California, United States, 92064
      • Arthritis Care and Research Center
    • San Diego, California, United States, 92119
      • MD Strategies Research Centers
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Miami, Florida, United States, 33143
      • QPS-Medical Research Assoc LLC
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research Corp.
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
    • Orlando, Florida, United States, 32806
      • Rheumatology Associates of Central Florida, PA
    • Orlando, Florida, United States, 32806
      • Accelerated Enrollment Solutions (AES)
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
    • Tampa, Florida, United States, 33614
      • Advent Health Group Multispecialty at Habana and Bruce B. Downs
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Arthritis Center of North Georgia
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research, Inc.
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Institute of Arthritis Research
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Maryland
    • Cumberland, Maryland, United States, 21502
      • Klein & Associates, M.D., P.A.
    • Hagerstown, Maryland, United States, 21740
      • Klein & Associates, M.D., P.A.
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Elite Clinical Research, LLC
  • Missouri
    • Blue Springs, Missouri, United States, 64014
      • TEST
  • New York
    • Brooklyn, New York, United States, 11201
      • NYU Langone Ambulatory Care Brooklyn Heights
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Leland, North Carolina, United States, 28451
      • Cape Fear Arthritis Care PLLC
    • Leland, North Carolina, United States, 28541
      • Cape Fear Arthritis Care PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Arthritis & Rheumatology Center of Oklamhoma, PLLC
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLC
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute, LLC
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center For Clinical Research
    • Austin, Texas, United States, 78745
      • Tekton Research
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc.
    • Mesquite, Texas, United States, 75150
      • SouthWest Rheumatology Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. History of symptomatic gout defined as:

   1. ≥ 3 gout flares within 18 months of Screening or
   2. Presence of ≥ 1 tophus or
   3. Current diagnosis of gouty arthritis

2. 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:

   1. > 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or
   2. Post-menopausal (> 24 months of natural amenorrhea)
3. 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;
4. Willing to provide written informed consent prior to the conduct of any study specific procedures;
5. Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits

Key Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEL-212; Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions	Drug: SEL-212; Administered as specified in the treatment arm
Active Comparator: KRYSTEXXA; IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions	Drug: KRYSTEXXA®; Administered as specified in the treatment arm; Other Names: Pegloticase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Eight categories were assessed by the HAQ-DI: 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reaching, 7) gripping, and 8) common daily activities. There were 2 or 3 questions for each category. Scoring within each category was on a 4-point Likert scale from 0 (without any difficulty) to 3 (unable to do). The score given to each section was the worst (highest) score within the section. The HAQ-DI total score was calculated if 6 or more sections were available. The average of the 8 category scores was reported as the HAQ-DI total score on a scale of 0 to 3. Reduction from baseline, and lower scores indicated better QoL.	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	The PrGA was administered to assess the severity of the participant's disease on a scale from 0 (participant feels "very well") to 100 (participant feels "very poor"). Reduction from baseline, and lower scores indicated less severe disease.	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	The SF-36 is a 36-item questionnaire to assesses a participant's health status using 8 health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The mental component reports the average of all the emotionally relevant items and the physical component reports the average of all the physical relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 indicates no disability. Median change can range from -100 to 100. A positive median change indicated an improved outcome.	Baseline to End of Month 3, Baseline to End of Month 6
Number of Participants With Gout Flares Per 3-Month Period		Month 1 to Month 3, Month 4 to Month 6
Number of Gout Flares Per 3-Month Period		Month 1 to Month 3, Month 4 to Month 6
Change From Baseline in Number of Tender Joints		Baseline to End of Month 6
Change From Baseline in Number of Swollen Joints		Baseline to End of Month 6

Collaborators and Investigators

• Sponsor: Selecta Biosciences, Inc.
• Investigators: Study Director: Medical Director, Selecta Biosciences, Inc.

Publications and helpful links

Helpful Links

• The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): August 5, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: SEL-212/202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No