A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Condition: Chronic Gout
MeSH terms: Gout
Intervention: SEL-212; KRYSTEXXA®
Intervention description: Administered as specified in the treatment arm; Administered as specified in the treatment arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Assessments of qualitative endpoints will be conducted on an assessor-blinded basis.
Enrollment: 170.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

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;