Back to resultsA Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy (COMPARE)
Primary Purpose
Chronic Gout
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SEL-212
KRYSTEXXA®
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Gout
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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;
- Patients 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;
Sites / Locations
- Pinnacle Research Group, LLC
- Arizona Arthritis & Rheumatology Research, PLLC
- Baptist Health Center for Clinical Research
- Medvin Clinical Research
- Valerius Medical Group and Research Center of Greater Long Beach, Inc.
- Arthritis Care and Research Center
- MD Strategies Research Centers
- Clinical Research of West Florida
- Panax Clinical Research
- QPS-Medical Research Assoc LLC
- Well Pharma Medical Research Corp.
- Accelerated Enrollment Solutions (AES)
- Rheumatology Associates of Central Florida, PA
- Clinical Research of West Florida, Inc.
- Advent Health Group Multispecialty at Habana and Bruce B. Downs
- Arthritis Center of North Georgia
- Better Health Clinical Research, Inc.
- Institute of Arthritis Research
- Great Lakes Clinical Trials
- L-MARC Research Center
- Klein & Associates, M.D., P.A.
- Klein & Associates, M.D., P.A.
- The Center for Rheumatology and Bone Research
- Clinical Pharmacology Study Group
- University Hospital
- Elite Clinical Research, LLC
- TEST
- NYU Langone Ambulatory Care Brooklyn Heights
- DJL Clinical Research
- Duke University Medical Center
- Cape Fear Arthritis Care PLLC
- Cape Fear Arthritis Care PLLC
- New Horizons Clinical Research
- Arthritis & Rheumatology Center of Oklamhoma, PLLC
- Altoona Center for Clinical Research
- Clinical Research Center of Reading, LLC
- West Tennessee Research Institute, LLC
- Amarillo Center for Clinical Research
- Austin Regional Clinic
- Tekton Research
- Metroplex Clinical Research Center
- Pioneer Research Solutions, Inc.
- Southwest Rheumatology Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SEL-212
KRYSTEXXA
Arm Description
Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During 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.
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.
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.
Number of Participants With Gout Flares Per 3-Month Period
Number of Gout Flares Per 3-Month Period
Change From Baseline in Number of Tender Joints
Change From Baseline in Number of Swollen Joints
Full Information
NCT ID
NCT03905512
First Posted
April 1, 2019
Last Updated
September 26, 2023
Sponsor
Selecta Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03905512
Brief Title
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Acronym
COMPARE
Official Title
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Selecta Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Assessments of qualitative endpoints will be conducted on an assessor-blinded basis.
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEL-212
Arm Type
Experimental
Arm Description
Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
Arm Title
KRYSTEXXA
Arm Type
Active Comparator
Arm Description
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions
Intervention Type
Drug
Intervention Name(s)
SEL-212
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
KRYSTEXXA®
Other Intervention Name(s)
Pegloticase
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
Description
The average of the data collected during Month 3 and Month 6 was reported.
Time Frame
Up to Month 6
Secondary Outcome Measure Information:
Title
Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
Time Frame
Month 6
Title
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
Time Frame
Month 6
Title
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
Description
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.
Time Frame
Baseline to End of Month 3, Baseline to End of Month 6
Title
QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
Description
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.
Time Frame
Baseline to End of Month 3, Baseline to End of Month 6
Title
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Description
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.
Time Frame
Baseline to End of Month 3, Baseline to End of Month 6
Title
Number of Participants With Gout Flares Per 3-Month Period
Time Frame
Month 1 to Month 3, Month 4 to Month 6
Title
Number of Gout Flares Per 3-Month Period
Time Frame
Month 1 to Month 3, Month 4 to Month 6
Title
Change From Baseline in Number of Tender Joints
Time Frame
Baseline to End of Month 6
Title
Change From Baseline in Number of Swollen Joints
Time Frame
Baseline to End of Month 6
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Selecta Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Arthritis Care and Research Center
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
MD Strategies Research Centers
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
QPS-Medical Research Assoc LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Well Pharma Medical Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Accelerated Enrollment Solutions (AES)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rheumatology Associates of Central Florida, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Advent Health Group Multispecialty at Habana and Bruce B. Downs
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Klein & Associates, M.D., P.A.
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Elite Clinical Research, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
TEST
City
Blue Springs
State/Province
Missouri
ZIP/Postal Code
64014
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Arthritis Care PLLC
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Cape Fear Arthritis Care PLLC
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28541
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklamhoma, PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Center of Reading, LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
West Tennessee Research Institute, LLC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Southwest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://doi.org/10.1093/rheumatology/kead333
Description
The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout
Learn more about this trial
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
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