Clinical trial NCT03905512: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Official title: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Gout
Lead sponsor: Selecta Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
timeFrame: Up to Month 6
Secondary outcomes:
measure: Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
timeFrame: Month 6
measure: Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
timeFrame: Month 6
measure: Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
timeFrame: Baseline to End of Month 3, Baseline to End of Month 6
measure: QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
timeFrame: Baseline to End of Month 3, Baseline to End of Month 6
measure: QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
timeFrame: Baseline to End of Month 3, Baseline to End of Month 6
measure: Number of Participants With Gout Flares Per 3-Month Period
timeFrame: Month 1 to Month 3, Month 4 to Month 6
measure: Number of Gout Flares Per 3-Month Period
timeFrame: Month 1 to Month 3, Month 4 to Month 6
measure: Change From Baseline in Number of Tender Joints
timeFrame: Baseline to End of Month 6
measure: Change From Baseline in Number of Swollen Joints
timeFrame: Baseline to End of Month 6
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Sun City
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group and Research Center of Greater Long Beach, Inc.
state: California
city: Poway
country: United States
facility: Arthritis Care and Research Center
state: California
city: San Diego
country: United States
facility: MD Strategies Research Centers
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: QPS-Medical Research Assoc LLC
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp.
state: Florida
city: Orlando
country: United States
facility: Accelerated Enrollment Solutions (AES)
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Advent Health Group Multispecialty at Habana and Bruce B. Downs
state: Florida
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Cumberland
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Hospital
state: Michigan
city: Jackson
country: United States
facility: Elite Clinical Research, LLC
state: Mississippi
city: Blue Springs
country: United States
facility: TEST
state: Missouri
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care PLLC
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklamhoma, PLLC
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute, LLC
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
Study officials:
affiliation: Selecta Biosciences, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: