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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905512
Recruitment Status : Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Selecta Biosciences, Inc.

Brief Summary:
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Patients 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.

Condition or disease Intervention/treatment Phase
Chronic Gout Drug: SEL-212 Drug: SEL-037 Drug: SEL-110 Drug: KRYSTEXXA® Phase 2

Detailed Description:

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Patients 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 patients in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study patients 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessments of qualitative endpoints will be conducted on an assessor-blinded basis.
Primary Purpose: Treatment
Official Title: A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Pegloticase

Arm Intervention/treatment
Experimental: SEL-212
IV infusion of SEL-212 every 28 days for a total of up to 6 infusions of SEL-212.
Drug: SEL-212
SEL-212

Drug: SEL-037
SEL-037, PEGylated uric acid specific enzyme (uricase)
Other Name: pegadricase, pegsiticase

Drug: SEL-110
ImmTOR (SEL-110)

Active Comparator: KRYSTEXXA
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for a total of up to 12 infusions of KRYSTEXXA®.
Drug: KRYSTEXXA®
KRYSTEXXA®, PEGylated uric acid specific enzyme (uricase)
Other Name: pegloticase




Primary Outcome Measures :
  1. Serum uric acid control [ Time Frame: 6 months ]
    To assess the change in serum uric acid (SUA) in patients treated with SEL-212 compared to KRYSTEXXA®


Secondary Outcome Measures :
  1. Serum uric acid concentration [ Time Frame: 6 months ]
    Comparison between patients treated with SEL-212 or KRYSTEXXA® for control of serum uric acid concentration.

  2. Comparison between patients treated with SEL-212 or KRYSTEXXA® for changes in health questionnaire [ Time Frame: 6 months ]
    Change from baseline in Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)

  3. Comparison between patients treated with SEL-212 or KRYSTEXXA® for changes in number of tender joints [ Time Frame: 6 months ]
    Change from baseline in number of tender joints per patient

  4. Comparison between patients treated with SEL-212 or KRYSTEXXA® for changes in number of swollen joints [ Time Frame: 6 months ]
    Change from baseline in number of swollen joints per patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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. Patients 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905512


Locations
Show Show 31 study locations
Sponsors and Collaborators
Selecta Biosciences, Inc.
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Responsible Party: Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03905512    
Other Study ID Numbers: SEL-212/202
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases