A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II (NCT04596540) | Clinical Trial Compass
CompletedPhase 3
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
United States153 participantsStarted 2020-11-30
Plain-language summary
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Has negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for detection of SARS-CoV-2 RNA from a nasal or oropharyngeal specimen;
âś“. History of symptomatic gout defined as:
✓. ≥ 3 gout flares within 18 months of Screening or
✓. Presence of ≥ 1 gout tophus or
âś“. Current diagnosis of gouty arthritis
âś“. At the Screening Visit: male age 21 - 80 years, inclusive, or female of non-childbearing potential age 21-80 years, inclusive, where nonchildbearing potential is defined as:
âś“. \> 6 weeks after hysterectomy with or without surgical bilateral salpingo-oophorectomy or
âś“. Post-menopausal (\> 24 months of natural amenorrhea or in the absence of \>24 months of amenorrhea, one documented confirmatory FSH measurement)
Exclusion criteria
âś•. Has a history of anaphylaxis, severe allergic reactions, or severe atopy;
What they're measuring
1
Proportion of Participants Who Achieved and Maintained Reduction in Serum Uric Acid (sUA) < 6 Milligrams Per Deciliter (mg/dL) for At Least 80% of The Time During Treatment Period 6 (Month 6)
✕. Has a history of any allergy to pegylated products, including, but not limited to pegloticase (Krystexxa®), peginterferon alfa-2a (Pegasys®), peginterferon alfa-2b (PegIntron®), pegfilgrastim (Neulasta®), pegaptanib (Macugen®), pegaspargase (Oncaspar®), pegademase (Adagen®), peg-epoetin beta (Mircera®), pegvisomant (Somavert®) certolizumab pegol (Cimzia®), naloxegol (Movantik®), peginesatide (Omontys®), and doxorubicin liposome (Doxil®);
âś•. Is taking and cannot discontinue known major CYP3A4/P-gp inhibitors or major CYP3A4/P-gp inducers at least 14 days before dosing. Patients must remain off these medications for the duration of the study, including natural products such as St. John's Wort or grapefruit juice.
✕. Is taking drugs known to interact with rapamycin (sirolimus - Rapamune®) such as cyclosporine, diltiazem, erythromycin, ketoconazole, posaconazole, voriconazole, itraconazole, rifampin, verapamil unless they are stopped 14 days prior to dosing and will not be used/prescribed during the trial.
âś•. Had major surgery within 3 months of initial screening.
âś•. Had a gout flare during Screening that was resolved for less than 1 week prior to first treatment with study drug (exclusive of chronic synovitis/arthritis) unless the patient has a history of inter-flare intervals of \< 1 week.
✕. Has uncontrolled diabetes at Screening with HbA1c ≥ 8.5%;