Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 was performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
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). The SEL-212 doses differed as to the SEL-110.36 component. Participants received SEL-037 administered at a dose of 0.2 mg/kg via intravenous (IV) infusion immediately after receiving SEL-110.36 at a dose of either 0.1 mg/kg (SEL-212 low-dose) or 0.15 mg/kg (SEL-212 high-dose) via IV infusion. The placebo consisted of normal saline.
Upon completion of the 6-month double-blinded, placebo-controlled portion of the study, SEL-212/301 continued in a blinded, placebo-controlled 6-month extension. This provided up to 12 months of continuous treatment with SEL-212 in a placebo controlled fashion.
Efficacy assessments were conducted at intervals that are appropriate to determine treatment effect with samples for the primary endpoint drawn during Treatment Period 6. Safety was monitored throughout the study with an independent data safety monitoring board (DSMB).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEL-212 low-dose | Experimental | SEL-212 low-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.1 mg/kg) SEL-110.36, ImmTOR |
|
| SEL-212 high-dose | Experimental | SEL-212 high-dose Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase Drug: SEL-110.36 (0.15 mg/kg) SEL-110.36, ImmTOR |
|
| Placebo | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEL-212 low-dose | Drug | IV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean sUA | Baseline, Up to 6 months | |
| Percentage Change From Baseline in Mean sUA | Baseline, Up to 6 months | |
| Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36) |
Not provided
Inclusion Criteria:
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;
History of symptomatic gout defined as:
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:
a. > 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or b. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24 months of amenorrhea, one documented confirmatory FSH measurement)
Has chronic refractory gout defined as having failed to normalize sUA and whose signs and symptoms are inadequately controlled with any of the xanthine oxidase inhibitors, or for whom these drugs are contraindicated for the patient;
Has at the Screening Visit SUA ≥ 7 mg/dL
Negative serology for HIV-1/-2 and negative antigen to hepatitis B and negative antibodies to hepatitis C;
Exclusion Criteria:
Has a history of anaphylaxis, severe allergic reactions, or severe atopy;
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®);
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.
Had major surgery within 3 months of initial screening.
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%;
Has fasting Screening glucose > 240 mg/dL;
Has fasting Screening triglyceride > 500 mg/dL;
Has fasting Screening low-density lipoprotein (LDL) > 200 mg/dL;
Has glucose-6-phosphate dehydrogenase (G6PD) deficiency;
Has uncontrolled hypertension defined as blood pressure > 170/100 mmHg at Screening and 1 week prior to dosing
Individual laboratory values which are exclusionary
Is receiving ongoing treatment for arrhythmia, including placement of an implantable defibrillator, unless considered stable and on active treatment;
Has evidence of unstable cardiovascular disease or unstable cerebrovascular vascular disease. This includes patients who have had a cardiac/vascular event(s) in the last 3 months including heart attack, stroke or vascular bypass surgery or patients who are deemed, by their physician or PI, to have active cardiovascular, cerebrovascular or peripheral vascular symptoms/disease inadequately controlled by medication;
Has congestive heart failure, New York Heart Association Class III or IV;
Unless clinically stable and/or appropriately treated, electrocardiogram (ECG) with evidence of clinically significant arrhythmia or other abnormalities that, in the opinion of the investigator, are consistent with significant underlying cardiac disease;
History of significant hematological disorders within 5 years or autoimmune disorders, and/or patient is currently immunosuppressed or immunocompromised;
Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®), pegadricase (SEL 37))
Patient has received a live vaccine in the previous 6 months.
Patient is planning to receive any live vaccine during the study.
History of malignancy within the last 5 years other than basal skin cancer;
Patients with a documented history of moderate or severe alcohol or substance use disorder within the 12 months prior to randomization.
History of or evidence of clinically severe interstitial lung disease
Immunocompromised state, regardless of etiology
female of non-childbearing potential defined as either >6 weeks after hysterectomy with or without surgical bilateral salpingo-oophorectomy OR post-menopausal (> 24 months of natural amenorrhea or in the absence of > 24 months of amenorrhea, one documented confirmatory FSH measurement)
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Arizona Arthritis & Rheumatology Research, PLLC |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SEL-212A (Low-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [low-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2022 | Jun 18, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SEL-212 high-dose | Drug | IV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions |
|
| Normal Saline | Other | IV infusion of Normal Saline every 28 days for a total of up to 12 infusions |
|
The SF-36 is a 36-item scale constructed to survey health status and quality of life (QoL). The SF-36 assesses 8 health concepts, which are the weighted sums of the questions in their section: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Each scale was directly transformed into a 0-100 scale, and the total average scores were calculated across the 8 health concepts. The 8 domains contributed to physical component summary and mental component summary scores. Total scores for the physical component summary score ranged from 0-100, with a higher score indicating better health outcomes. |
| Baseline, Up to 6 months |
| Proportion of Participants With at Least Partial Response (PR) (as Best Response) in Overall Tophus Response Evaluation in Participants With Tophi at Baseline | Baseline photographs of the hands and feet of each participant were obtained using a standardized method in all participants together with photographs of up to 2 other representative sites of tophaceous disease. The baseline photographs were assessed by three independent reviewers to prospectively identify sites of tophaceous disease present at the start of treatment. Up to 5 tophi in the photographs were chosen by the reviewers for measurement over the course of therapy. The reviewers assessed the photographs for size of each target tophus using image analysis software. At least PR was defined as at least a 50% decrease in the area of at least one tophus, and includes participants with complete response (CR). Data are presented for the proportion of participants with at least PR (as best response). | Baseline up to 6 months |
| Proportion of Participants Who Achieved and Maintained Reduction of sUA < 6 mg/dL for at Least 80% of the Time During Month 6 in the Subset of Participants With Tophi at Baseline | The number of responders in the subgroup of Intent-to-Treat participants with tophi at baseline divided by the number of Intent-to-Treat participants with tophi at baseline. | Baseline up to 6 months |
| Change From Baseline to Month 6 in Number of Tender Joints | Tender and/or swollen joints were counted. The following joints were assessed: metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of the hands; the metatarsophalangeal and interphalangeal joints of the feet; shoulder, elbow, wrist, knee, ankle, tarsus, sternoclavicular, and acromioclavicular joints. | Baseline, Up to 6 months |
| Change From Baseline to Month 6 in the Total Score of the Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI assesses fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both the upper and lower extremities. It includes 20 items in 8 categories: "activity", "arising", "dressing and grooming", "eating", "grip", "hygiene", "reach" and "walking". Scoring within each section was on a 4-point Likert scale from 0 (without any difficulty) to 3 (unable to do), with higher score showing more disability. The average of the 8 category scores was reported as the HAQ-DI total score on a scale of 0 to 3. A decrease in HAQ-DI score from baseline indicated an improvement in the participant's condition. | Baseline, Up to 6 months |
| Incidence of Gout Flare During Treatment Periods 1-6 (Months 1-6) | Gout flare was assessed as part of adverse event (AE) collection. Gout flares were assessed during the Treatment Phase using a validated definition of flares in participants with established gout. A gout flare (per Gaffo et al. 2018) was defined as the fulfillment of at least 3 of the following 4 criteria: 1. Participant-defined gout flare, 2. Pain at rest score of >3 on a 0-10-point numerical rating scale, 3. Presence of at least 1 swollen joint, 4. Presence of at least 1 warm joint. Data are presented for the LS mean incidence per month of gout flares during Treatment Periods 1-6 (Months 1-6). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Months 1-6 |
| Incidence of Gout Flare During Treatment Periods 1-3 (Months 1-3) | Gout flare was assessed as part of adverse event (AE) collection. Gout flares were assessed during the Treatment Phase using a validated definition of flares in participants with established gout. A gout flare (per Gaffo et al. 2018) was defined as the fulfillment of at least 3 of the following 4 criteria: 1. Participant-defined gout flare, 2. Pain at rest score of >3 on a 0-10-point numerical rating scale, 3. Presence of at least 1 swollen joint, 4. Presence of at least 1 warm joint. Data are presented for the LS mean incidence per month of gout flares during Treatment Periods 1-3 (Months 1-3). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Months 1-3 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Medvin Clinical Research | Covina | California | 91722 | United States |
| Valerius Medical Group & Research Center | Los Alamitos | California | 90720 | United States |
| ACRC Studies | Poway | California | 92064 | United States |
| MD Strategies Research Center | San Diego | California | 92119 | United States |
| Tekton Research - Fort Collins | Fort Collins | Colorado | 80528 | United States |
| Helix Biomedics, LLC | Boynton Beach | Florida | 33435 | United States |
| Clinical Research Of West Florida Incorporated | Clearwater | Florida | 33765 | United States |
| Omegas Research Consultants LLC | DeBary | Florida | 32713 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Homestead Associates in Research,Inc | Homestead | Florida | 33032 | United States |
| Health Awareness INC | Jupiter | Florida | 33458 | United States |
| Y & L Advance Health Care, Inc | Miami | Florida | 33144 | United States |
| Well Pharma Medical Research, Corp | Miami | Florida | 33173 | United States |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian | Meridian | Idaho | 83642 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Research Integrity, LLC | Owensboro | Kentucky | 42303 | United States |
| Klein and Associates, M.D., P.A. | Cumberland | Maryland | 21502 | United States |
| Klein and Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| Elite Clinical Research, LLC | Jackson | Mississippi | 39216 | United States |
| Arthritis Consultants, Inc. | St Louis | Missouri | 63141 | United States |
| Montana Medical Research, Inc. | Missoula | Montana | 59808 | United States |
| Medex Healthcare Research, Inc. | New York | New York | 10036 | United States |
| CFA - Cape Fear Arthritis Care, PLLC | Leland | North Carolina | 28451 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Arthritis & Rheumatology Center of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73102 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | United States |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | United States |
| AIM Trials - Internal Medicine | Plano | Texas | 75234 | United States |
| Epic Medical Research | Red Oak | Texas | 75154 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23220 | United States |
| FG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| FG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| Received at Least 1 Dose of Study Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
|
Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to the treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SEL-212A (Low-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [low-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| BG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| BG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Intent-to-Treat Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Number | proportion of participants | Month 6 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean sUA | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Up to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Mean sUA | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Up to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36) | The SF-36 is a 36-item scale constructed to survey health status and quality of life (QoL). The SF-36 assesses 8 health concepts, which are the weighted sums of the questions in their section: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Each scale was directly transformed into a 0-100 scale, and the total average scores were calculated across the 8 health concepts. The 8 domains contributed to physical component summary and mental component summary scores. Total scores for the physical component summary score ranged from 0-100, with a higher score indicating better health outcomes. | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With at Least Partial Response (PR) (as Best Response) in Overall Tophus Response Evaluation in Participants With Tophi at Baseline | Baseline photographs of the hands and feet of each participant were obtained using a standardized method in all participants together with photographs of up to 2 other representative sites of tophaceous disease. The baseline photographs were assessed by three independent reviewers to prospectively identify sites of tophaceous disease present at the start of treatment. Up to 5 tophi in the photographs were chosen by the reviewers for measurement over the course of therapy. The reviewers assessed the photographs for size of each target tophus using image analysis software. At least PR was defined as at least a 50% decrease in the area of at least one tophus, and includes participants with complete response (CR). Data are presented for the proportion of participants with at least PR (as best response). | Intent-to-Treat Set, which included all randomized and dosed participants, including participants with missing outcome measure data that were multiple imputed. Participants were analyzed according to randomized treatment. Here, overall number of participants analyzed = participants with tophi at baseline and evaluable data for the outcome measure. | Posted | Number | 97.5% Confidence Interval | proportion of participants | Baseline up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Achieved and Maintained Reduction of sUA < 6 mg/dL for at Least 80% of the Time During Month 6 in the Subset of Participants With Tophi at Baseline | The number of responders in the subgroup of Intent-to-Treat participants with tophi at baseline divided by the number of Intent-to-Treat participants with tophi at baseline. | Intent-to-Treat Set, which included all randomized and dosed participants, including participants with missing outcome measure data that were multiple imputed. Participants were analyzed according to randomized treatment. Here, overall number of participants analyzed = participants with tophi at baseline and evaluable data for the outcome measure. | Posted | Number | 97.5% Confidence Interval | proportion of participants | Baseline up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Month 6 in Number of Tender Joints | Tender and/or swollen joints were counted. The following joints were assessed: metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of the hands; the metatarsophalangeal and interphalangeal joints of the feet; shoulder, elbow, wrist, knee, ankle, tarsus, sternoclavicular, and acromioclavicular joints. | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | tender joints | Baseline, Up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Month 6 in the Total Score of the Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI assesses fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both the upper and lower extremities. It includes 20 items in 8 categories: "activity", "arising", "dressing and grooming", "eating", "grip", "hygiene", "reach" and "walking". Scoring within each section was on a 4-point Likert scale from 0 (without any difficulty) to 3 (unable to do), with higher score showing more disability. The average of the 8 category scores was reported as the HAQ-DI total score on a scale of 0 to 3. A decrease in HAQ-DI score from baseline indicated an improvement in the participant's condition. | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Gout Flare During Treatment Periods 1-6 (Months 1-6) | Gout flare was assessed as part of adverse event (AE) collection. Gout flares were assessed during the Treatment Phase using a validated definition of flares in participants with established gout. A gout flare (per Gaffo et al. 2018) was defined as the fulfillment of at least 3 of the following 4 criteria: 1. Participant-defined gout flare, 2. Pain at rest score of >3 on a 0-10-point numerical rating scale, 3. Presence of at least 1 swollen joint, 4. Presence of at least 1 warm joint. Data are presented for the LS mean incidence per month of gout flares during Treatment Periods 1-6 (Months 1-6). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | gout flares/month | Months 1-6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Gout Flare During Treatment Periods 1-3 (Months 1-3) | Gout flare was assessed as part of adverse event (AE) collection. Gout flares were assessed during the Treatment Phase using a validated definition of flares in participants with established gout. A gout flare (per Gaffo et al. 2018) was defined as the fulfillment of at least 3 of the following 4 criteria: 1. Participant-defined gout flare, 2. Pain at rest score of >3 on a 0-10-point numerical rating scale, 3. Presence of at least 1 swollen joint, 4. Presence of at least 1 warm joint. Data are presented for the LS mean incidence per month of gout flares during Treatment Periods 1-3 (Months 1-3). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Intent-to-Treat Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. | Posted | Least Squares Mean | Standard Error | gout flares/month | Months 1-3 |
|
Day 1 up to approximately 12 months
Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEL-212A (Low-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [low-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. | 0 | 37 | 10 | 37 | 31 | 37 |
| EG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. | 1 | 38 | 5 | 38 | 29 | 38 |
| EG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. | 0 | 37 | 2 | 37 | 27 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA V25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA V25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gout | Metabolism and nutrition disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Hypertriglycerideaemia | Metabolism and nutrition disorders | MedDRA V25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA V25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA V25.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA V25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Gouty tophus | Musculoskeletal and connective tissue disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA V25.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA V25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blank Clinical Study Physician, MD | Swedish Orphan Biovitrum AB (publ) | +46 8 697 20 00 | medical.info@sobi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2023 | Aug 15, 2025 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Lost to Follow-up |
|
| Sponsor Decision |
|
| Death |
|
| Adverse Event |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Risk Difference (RD) |
| 0.53 |
| 2-Sided |
| 97.5 |
| 0.32 |
| 0.73 |
| Superiority |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|
| OG001 | SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A [high-dose]) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
| OG002 | Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. |
|
|
|