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

Chronic Gout Clinical Trial

— COMPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905512
• Other study ID #: SEL-212/202
• Status: Completed
• Phase: Phase 2
• Start date: May 7, 2019
• Est. completion date: August 5, 2020

Study information

• Verified date: September 2023
• Source: Selecta Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Gout
• Gout

Intervention

Drug:
• SEL-212
Administered as specified in the treatment arm
• KRYSTEXXA®
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	University Hospital	Ann Arbor	Michigan
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Austin Regional Clinic	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	TEST	Blue Springs	Missouri
United States	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Medvin Clinical Research	Covina	California
United States	Klein & Associates, M.D., P.A.	Cumberland	Maryland
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Arthritis Center of North Georgia	Gainesville	Georgia
United States	Klein & Associates, M.D., P.A.	Hagerstown	Maryland
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Institute of Arthritis Research	Idaho Falls	Idaho
United States	Elite Clinical Research, LLC	Jackson	Mississippi
United States	West Tennessee Research Institute, LLC	Jackson	Tennessee
United States	Cape Fear Arthritis Care PLLC	Leland	North Carolina
United States	Cape Fear Arthritis Care PLLC	Leland	North Carolina
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Valerius Medical Group and Research Center of Greater Long Beach, Inc.	Los Alamitos	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	QPS-Medical Research Assoc LLC	Miami	Florida
United States	Well Pharma Medical Research Corp.	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Better Health Clinical Research, Inc.	Newnan	Georgia
United States	Arthritis & Rheumatology Center of Oklamhoma, PLLC	Oklahoma City	Oklahoma
United States	Accelerated Enrollment Solutions (AES)	Orlando	Florida
United States	Rheumatology Associates of Central Florida, PA	Orlando	Florida
United States	Arthritis Care and Research Center	Poway	California
United States	MD Strategies Research Centers	San Diego	California
United States	Arizona Arthritis & Rheumatology Research, PLLC	Sun City	Arizona
United States	Advent Health Group Multispecialty at Habana and Bruce B. Downs	Tampa	Florida
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Clinical Research Center of Reading, LLC	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Selecta Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6		Month 6
Secondary	Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6		Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Gout Flares Per 3-Month Period		Month 1 to Month 3, Month 4 to Month 6
Secondary	Number of Gout Flares Per 3-Month Period		Month 1 to Month 3, Month 4 to Month 6
Secondary	Change From Baseline in Number of Tender Joints		Baseline to End of Month 6
Secondary	Change From Baseline in Number of Swollen Joints		Baseline to End of Month 6

External Links

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