Phase 2
N=170
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Chronic Gout
Bottom Line
View on ClinicalTrials.gov: NCT03905512 ↗Enrolled (actual)
170
Serious AEs
8.8%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time — 44; 40 Participants — p=0.181
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SEL-212 (Drug); KRYSTEXXA® (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Selecta Biosciences, Inc.
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time |
44; 40 | 0.181 |
| SECONDARY Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6 |
45; 41 | — |
| SECONDARY Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 |
38; 36 | — |
| SECONDARY Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale |
0.78; 0.79; -0.14; -0.10; 0.04; -0.12 | — |
| SECONDARY QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale |
42.8; 40.5; -20.9; -15.8; -24.6; -22.0 | — |
| SECONDARY QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale |
43.822; 43.345; 3.323; 5.768; 5.881; 7.448 | — |
| SECONDARY Number of Participants With Gout Flares Per 3-Month Period |
50; 42; 16; 15 | — |
| SECONDARY Number of Gout Flares Per 3-Month Period |
1.1; 0.8; 0.2; 0.3 | — |
| SECONDARY Change From Baseline in Number of Tender Joints |
5.2; 4.1; -2.4; -2.7 | — |
| SECONDARY Change From Baseline in Number of Swollen Joints |
3.0; 3.7; -1.6; -1.9 | — |
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
- 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
- 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
Key Exclusion Criteria
- 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;
- 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;
Data sourced from ClinicalTrials.gov (NCT03905512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.