Chronic GoutPhase 3DISSOLVE INCT04513366
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
A Phase 3 study testing SEL-212 low-dose, SEL-212 high-dose and Normal Saline in people with Chronic Gout, run by Swedish Orphan Biovitrum at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Gout
- What is being tested?
- SEL-212 low-dose, SEL-212 high-dose and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 40 sitesUnited States
- Study dates
- 18 Aug 2020to 1 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- ≥ 3 gout flares within 18 months of Screening or
- Presence of ≥ 1 gout 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 nonchildbearing potential is defined as:
Show all 10Show fewer
- > 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;
Who cannot join
- 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.
Show all 31Show fewer
- 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
- White blood cell count (WBC) < 3.0 x109/L
- Serum aspartate aminotransferase (AST) or alanine amino transferase (ALT) > 3x upper limit of normal (ULN) in the absence of known active liver disease
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- Urine albumin creatinine ratio (UACR) > 30 mg/g
- Hemoglobin (Hgb) < 9 g/dL
- Serum phosphate < 2.0 mg/dL
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Helix Biomedics, LLC
Boynton Beach, Florida, 33435
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Clinical Research Of West Florida Incorporated
Clearwater, Florida, 33765
Medvin Clinical Research
Covina, California, 91722
Klein and Associates, M.D., P.A.
Cumberland, Maryland, 21502
Metroplex Clinical Research Center
Dallas, Texas, 75231
Omegas Research Consultants LLC
DeBary, Florida, 32713
Riverside Clinical Research
Edgewater, Florida, 32132
Tekton Research - Fort Collins
Fort Collins, Colorado, 80528
Klein and Associates, M.D., P.A.
Hagerstown, Maryland, 21740
Homestead Associates in Research,Inc
Homestead, Florida, 33032
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Elite Clinical Research, LLC
Jackson, Mississippi, 39216
West Tennessee Research Institute
Jackson, Tennessee, 38305
Health Awareness INC
Jupiter, Florida, 33458
CFA - Cape Fear Arthritis Care, PLLC
Leland, North Carolina, 28451
Valerius Medical Group & Research Center
Los Alamitos, California, 90720
L-MARC Research Center
Louisville, Kentucky, 40213
Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
Meridian, Idaho, 83642
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150
Y & L Advance Health Care, Inc
Miami, Florida, 33144
Well Pharma Medical Research, Corp
Miami, Florida, 33173
Panax Clinical Research
Miami Lakes, Florida, 33014
Montana Medical Research, Inc.
Missoula, Montana, 59808
Medex Healthcare Research, Inc.
New York, New York, 10036
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265
Arthritis & Rheumatology Center of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73102
Research Integrity, LLC
Owensboro, Kentucky, 42303
AIM Trials - Internal Medicine
Plano, Texas, 75234
ACRC Studies
Poway, California, 92064
Epic Medical Research
Red Oak, Texas, 75154
Clinical Research Partners, LLC
Richmond, Virginia, 23220
MD Strategies Research Center
San Diego, California, 92119
Arthritis Consultants, Inc.
St Louis, Missouri, 63141
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, 85351
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606
Conquest Research
Winter Park, Florida, 32789
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
About this study
Official title: A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
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.
Read the detailed description
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).
- Conditions
- Chronic Gout
- Being tested
- SEL-212 low-dose, SEL-212 high-dose, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEL-212 low-doseDrug
IV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions
SEL-212 high-doseDrug
IV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions
Normal SalineOther
IV infusion of Normal Saline every 28 days for a total of up to 12 infusions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SEL-212 low-dose |
| 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 Receives: Drug: SEL-212 high-dose |
| Placebo | Placebo comparator | Normal saline Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 6
Secondary outcomes (9)
Change From Baseline in Mean sUA
Measured: Baseline, Up to 6 months
Percentage Change From Baseline in Mean sUA
Measured: Baseline, Up to 6 months
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Months 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start18 Aug 2020
- Primary completion21 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic GoutStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513366
- Sponsor's protocol ID
- SEL-212/301
- Acronym
- DISSOLVE I
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2020
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
- ClinicalTrials.gov ID
- NCT04513366
- Acronym / sponsor ID
- DISSOLVE I / SEL-212/301
- Conditions
- Chronic Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEL-212 low-dose | Experimental | Drug: SEL-212 low-doseSEL-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 | Drug: SEL-212 high-doseSEL-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 | Other: Normal SalineNormal saline |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEL-212 low-doseIV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions | Drug | SEL-212 low-dose |
| SEL-212 high-doseIV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions | Drug | SEL-212 high-dose |
| Normal SalineIV infusion of Normal Saline every 28 days for a total of up to 12 infusions | Other | Placebo |
Primary outcome
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)
Time frame: Month 6
9 secondary outcomes
Change From Baseline in Mean sUA
Time frame: Baseline, Up to 6 months
Percentage Change From Baseline in Mean sUA
Time frame: Baseline, Up to 6 months
Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36)
Time frame: 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
Time frame: 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
Time frame: Baseline up to 6 months
Change From Baseline to Month 6 in Number of Tender Joints
Time frame: Baseline, Up to 6 months
Change From Baseline to Month 6 in the Total Score of the Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline, Up to 6 months
Incidence of Gout Flare During Treatment Periods 1-6 (Months 1-6)
Time frame: Months 1-6
Incidence of Gout Flare During Treatment Periods 1-3 (Months 1-3)
Time frame: Months 1-3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SEL-212 low-dose, SEL-212 high-dose and Normal Saline in people with Chronic Gout, run by Swedish Orphan Biovitrum at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.