Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEL-212 | Experimental | Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions |
|
| KRYSTEXXA | Active Comparator | IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEL-212 | Drug | Administered as specified in the treatment arm |
| |
| 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 |
| 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 |
Not provided
Key Inclusion Criteria:
History of symptomatic gout defined as:
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:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Selecta Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Arizona Arthritis & Rheumatology Research, PLLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37449908 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were enrolled across clinical sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SEL-212 | Participants received SEL-212 via intravenous (IV) infusion every 28 days for up to 6 months |
| FG001 | KRYSTEXXA | Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2020 | Aug 24, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Assessments of qualitative endpoints will be conducted on an assessor-blinded basis.
Not provided
| KRYSTEXXA® |
| Drug |
Administered as specified in the treatment arm |
|
|
| 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 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Medvin Clinical Research | Covina | California | 91722 | United States |
| Valerius Medical Group and Research Center of Greater Long Beach, Inc. | Los Alamitos | California | 90720 | United States |
| Arthritis Care and Research Center | Poway | California | 92064 | United States |
| MD Strategies Research Centers | San Diego | California | 92119 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| QPS-Medical Research Assoc LLC | Miami | Florida | 33143 | United States |
| Well Pharma Medical Research Corp. | Miami | Florida | 33143 | United States |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | United States |
| Accelerated Enrollment Solutions (AES) | Orlando | Florida | 32806 | United States |
| Rheumatology Associates of Central Florida, PA | Orlando | Florida | 32806 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | United States |
| Advent Health Group Multispecialty at Habana and Bruce B. Downs | Tampa | Florida | 33614 | United States |
| Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | United States |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Klein & Associates, M.D., P.A. | Cumberland | Maryland | 21502 | United States |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| University Hospital | Ann Arbor | Michigan | 48109 | United States |
| Elite Clinical Research, LLC | Jackson | Mississippi | 39202 | United States |
| TEST | Blue Springs | Missouri | 64014 | United States |
| NYU Langone Ambulatory Care Brooklyn Heights | Brooklyn | New York | 11201 | United States |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cape Fear Arthritis Care PLLC | Leland | North Carolina | 28451 | United States |
| Cape Fear Arthritis Care PLLC | Leland | North Carolina | 28541 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Arthritis & Rheumatology Center of Oklamhoma, PLLC | Oklahoma City | Oklahoma | 73102 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Center of Reading, LLC | Wyomissing | Pennsylvania | 19610 | United States |
| West Tennessee Research Institute, LLC | Jackson | Tennessee | 38305 | United States |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | United States |
| Austin Regional Clinic | Austin | Texas | 78731 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | United States |
| Southwest Rheumatology Research, LLC | Mesquite | Texas | 75150 | United States |
| Received At Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SEL-212 | Participants received SEL-212 via IV infusion every 28 days for up to 6 months |
| BG001 | KRYSTEXXA | Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT set included all randomized participants. | Posted | Count of Participants | Participants | 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 | ITT set included all randomized participants. | Posted | Count of Participants | Participants | Month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 | ITT set included all randomized participants. | Posted | Count of Participants | Participants | 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. | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Mean | Standard Deviation | score on a scale | 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. | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Mean | Standard Deviation | score on a scale | 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. | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Mean | Standard Deviation | score on a scale | Baseline to End of Month 3, Baseline to End of Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Gout Flares Per 3-Month Period | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Count of Participants | Participants | Month 1 to Month 3, Month 4 to Month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Gout Flares Per 3-Month Period | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Mean | Standard Deviation | number of flares | Month 1 to Month 3, Month 4 to Month 6 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Number of Tender Joints | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Mean | Standard Deviation | number of tender joints | Baseline to End of Month 6 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Number of Swollen Joints | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Posted | Mean | Standard Deviation | number of swollen joints | Baseline to End of Month 6 |
|
|
Up to 7 months
Safety Set included all participants who received the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEL-212 | Participants received SEL-212 via IV infusion every 28 days for up to 6 months | 0 | 83 | 7 | 83 | 60 | 83 |
| EG001 | KRYSTEXXA | Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months | 0 | 87 | 8 | 87 | 53 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Infusion Related reaction | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Selecta Biosciences, Inc. | 617-923-1400 | ptraber@selectabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2020 | Aug 24, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C031545 | Pegloticase |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months |
|
|
|
|
|
|