Gout Chronic, Hyperuricemia
Conditions
Brief summary
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses ( 5 monthly IV infusions) of pegsiticase (SEL-037) alone. Participants will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to weekly serum uric acid levels.
Detailed description
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase ( SEL-037, also known as pegadricase) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in participants with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses (5 monthly IV infusions) of pegsiticase (SEL-037) alone. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. All participants will be monitored for safety and tolerability to drug throughout the study on a weekly schedule. Pharmacokinetic and pharmacodynamic parameters will at specific timepoints to monitor for continued efficacy. Pharmacodynamic parameters measured include uric acid levels and levels of ADAs. The study duration per enrolled participant will be approximately 6 months including a 1 month screening period followed by 5 treatment cycles and an end of treatment visit which will occur 30 days after the last IV infusion .
Interventions
Sponsors
Selecta Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adult (age 21-75 inclusive) men and women of non child bearing potential with established or symptomatic gout which is defined as having at least ONE of any of the 3 following factors: 1. ≥ 1 tophus 2. 1 gout flare within the last 6 months 3. Chronic gouty arthropathy 2. Screening serum uric acid of \>6 mg/dL 3. On a gout flare prophylactic regimen for 7 days prior to first dose 4. Willing to provide written informed consent prior to first study procedure is performed. 5. Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits.
Exclusion criteria
1. History of anaphylaxis or severe allergic reaction. 2. History of an allergy to pegylated products. 3. Women of child bearing potential, Defined as: * \<6 weeks after surgical bilateral salpingooperhectony with or without hysterectomy * Pre or perimenopausal ( \< less than 24 months of natural amenorrhea) 4. Initiation or change in dose of hormone-replacement therapy for menopausal women less than 1 month prior to the Screening Visit or during the Screening Phase would be exclusionary. If after being on a stable dose of hormone-replacement therapy for one month the patient may be considered for the study if she continues to meet all other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | Five monthly infusions | To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | 3 and 5 months | Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SEL-037 (Pegadricase) Low Dose Pegardricase 0.2 mg/kg every 28 days for up to 5 doses | 3 |
| SEL-037 (Pegadricase) High Dose Pegardricase 0.4 mg/kg every 28 days for up to 5 doses | 3 |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses | 9 |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses | 10 |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses | 6 |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses | 11 |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses | 11 |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses | 12 |
| SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses | 14 |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses | 13 |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses | 14 |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses | 23 |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low for 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low 4 Doses SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 Dose Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 4 Doses | 11 |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses | 12 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 | 0 | 0 | 2 | 2 | 1 | 2 | 1 | 1 | 3 | 2 | 4 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | PI Discretion due to abnormal Hgb results | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Sponsor Decision, Pause in Clinical Trial | 1 | 2 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Stopping Rule Met | 1 | 0 | 3 | 4 | 5 | 3 | 2 | 4 | 1 | 1 | 3 | 5 | 2 | 1 |
| Overall Study | Subject Hospitalized, out of window for next dosing period | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Subject under-dosed with study drug and removed by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 2 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | SEL-037 (Pegadricase) Low Dose | SEL-037 (Pegadricase) High Dose | SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses | SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low for 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low 4 Doses | SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 1 Participants | 2 Participants | 6 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 7 Participants | 9 Participants | 4 Participants | 6 Participants | 10 Participants | 10 Participants | 8 Participants | 12 Participants | 12 Participants | 21 Participants | 11 Participants | 10 Participants | 126 Participants |
| Race/Ethnicity, Customized Number Analyzed American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Number Analyzed Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Number Analyzed Black or African American | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 6 Participants | 4 Participants | 7 Participants | 1 Participants | 2 Participants | 40 Participants |
| Race/Ethnicity, Customized Number Analyzed Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Number Analyzed Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Number Analyzed White | 2 Participants | 0 Participants | 7 Participants | 5 Participants | 4 Participants | 9 Participants | 8 Participants | 8 Participants | 10 Participants | 6 Participants | 10 Participants | 14 Participants | 10 Participants | 10 Participants | 103 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 9 Participants | 9 Participants | 6 Participants | 8 Participants | 10 Participants | 10 Participants | 12 Participants | 12 Participants | 11 Participants | 22 Participants | 11 Participants | 12 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 9 | 0 / 10 | 0 / 6 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 23 | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 8 / 9 | 8 / 10 | 6 / 6 | 10 / 11 | 10 / 11 | 12 / 12 | 14 / 14 | 12 / 13 | 14 / 14 | 21 / 23 | 9 / 11 | 12 / 12 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 2 / 9 | 0 / 10 | 0 / 6 | 1 / 11 | 2 / 11 | 4 / 12 | 2 / 14 | 0 / 13 | 1 / 14 | 3 / 23 | 1 / 11 | 2 / 12 |
Outcome results
Primary
Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set
To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set
Time frame: Five monthly infusions
Population: Safety analysis set, dosed subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SEL-037 (Pegadricase) Low Dose | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 3 Participants |
| SEL-037 (Pegadricase) High Dose | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 3 Participants |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 9 Participants |
| SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 10 Participants |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 6 Participants |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 11 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 11 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 12 Participants |
| SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 14 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 13 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 14 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 23 Participants |
| SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 11 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses | Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set | 12 Participants |
Secondary
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Time frame: 3 and 5 months
Population: Eligible subjects are those who received the entire first dose, did not discontinue due to withdrawal of consent (during TP 1-4), a protocol deviation (during TP1-2) or a non-study drug-related SAE (during TP1-2). The outcome data is presented with arms combined by regimen (i.e. SEL-037 alone; SEL-212 for 3 doses \& SEL-037 for 2 doses; or SEL-212 for 5 doses) rather than by dosing arm as the outcome is most effected by the SEL-212 combination which results in suppression of anti-drug antibodies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SEL-037 (Pegadricase) Low Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 0 Participants |
| SEL-037 (Pegadricase) Low Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | NA Participants |
| SEL-037 (Pegadricase) High Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 51 Participants |
| SEL-037 (Pegadricase) High Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 27 Participants |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 23 Participants |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 21 Participants |
Secondary
Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110
Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA \< 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Time frame: 3 and 5 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SEL-037 (Pegadricase) Low Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 0 Participants |
| SEL-037 (Pegadricase) Low Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | NA Participants |
| SEL-037 (Pegadricase) High Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 0 Participants |
| SEL-037 (Pegadricase) High Dose | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | NA Participants |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 2 Participants |
| SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 1 Participants |
| SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 1 Participants |
| SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 1 Participants |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 0 Participants |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 4 Participants |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 3 Participants |
| SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 6 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 7 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 3 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 7 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 4 Participants |
| SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 5 Participants |
| SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 7 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 4 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 8 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 6 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 9 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 11 Participants |
| SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 12 Participants |
| SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 5 Participants |
| SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 4 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 5 | 6 Participants |
| SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses | Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 | Treatment Period 3 | 6 Participants |