Chronic GoutPhase 2COMPARENCT03905512

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

A Phase 2 study testing SEL-212 and KRYSTEXXA® in people with Chronic Gout, run by Selecta Biosciences, Inc. at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Chronic Gout
What is being tested?: SEL-212 and KRYSTEXXA®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 43 sitesUnited States
Study dates: 7 May 2019to 5 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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;

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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;

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

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

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions: Chronic Gout
Being tested: SEL-212, KRYSTEXXA®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SEL-212Drug
Administered as specified in the treatment arm
KRYSTEXXA®Drug
Also called Pegloticase
Administered as specified in the treatment arm

Study groups in NCT03905512
Study group	Role	What they receive
SEL-212	Experimental	Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions Receives: Drug: SEL-212
KRYSTEXXA	Active comparator	IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions Receives: Drug: KRYSTEXXA®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Month 6

Secondary outcomes (9)

Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
Measured: Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to End of Month 3, Baseline to End of Month 6
Number of Participants With Gout Flares Per 3-Month Period
Measured: Month 1 to Month 3, Month 4 to Month 6
Number of Gout Flares Per 3-Month Period
Measured: Month 1 to Month 3, Month 4 to Month 6
Change From Baseline in Number of Tender Joints
Measured: Baseline to End of Month 6
Change From Baseline in Number of Swollen Joints
Measured: Baseline to End of Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 20195 Aug 2020

First posted5 Apr 2019
Study start7 May 2019
Primary completion5 Aug 2020
Study completion5 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic GoutStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03905512
Sponsor's protocol ID: SEL-212/202
Acronym: COMPARE
Status last verified: Sep 2023
First submitted: 1 Apr 2019
Last updated: 17 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37449908

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
ClinicalTrials.gov ID: NCT03905512
Acronym / sponsor ID: COMPARE / SEL-212/202
Conditions: Chronic Gout
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Selecta Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 7 May 2019 (actual)
Primary completion: 5 Aug 2020 (actual)
Study completion: 5 Aug 2020 (actual)
First posted: 5 Apr 2019 (actual)
Results: Posted 17 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SEL-212	Experimental	Drug: SEL-212Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
KRYSTEXXA	Active comparator	Drug: KRYSTEXXA®IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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 (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SEL-212Administered as specified in the treatment arm	Drug	SEL-212
KRYSTEXXA®Also: PegloticaseAdministered as specified in the treatment arm	Drug	KRYSTEXXA

Primary outcome

Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
Time frame: Up to Month 6
The average of the data collected during Month 3 and Month 6 was reported.

9 secondary outcomes

Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
Time frame: Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
Time frame: Month 6
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
Time frame: 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
Time frame: 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
Time frame: Baseline to End of Month 3, Baseline to End of Month 6
Number of Participants With Gout Flares Per 3-Month Period
Time frame: Month 1 to Month 3, Month 4 to Month 6
Number of Gout Flares Per 3-Month Period
Time frame: Month 1 to Month 3, Month 4 to Month 6
Change From Baseline in Number of Tender Joints
Time frame: Baseline to End of Month 6
Change From Baseline in Number of Swollen Joints
Time frame: Baseline to End of Month 6

Results and safety

Results posted to the registry on 17 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SEL-212	83	62
KRYSTEXXA	87	70

Primary outcome: Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time

Time frame: Up to Month 6. Count of participants. Unit: Participants

Measure	SEL-212 n = 83	KRYSTEXXA n = 87
Value	44	40

SEL-212 vs KRYSTEXXA: p = 0.181, Cochran-Mantel-Haenszel

Population analysed: ITT set included all randomized participants.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SEL-212	7 of 83 (8.4%)	60 of 83 (72.3%)	0 of 83
KRYSTEXXA	8 of 87 (9.2%)	53 of 87 (60.9%)	0 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37449908Baraf 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Selecta Biosciences, Inc.

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SEL-212 and KRYSTEXXA® in people with Chronic Gout, run by Selecta Biosciences, Inc. at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03905512, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.