Chronic GoutPhase 3DISSOLVE IINCT04596540
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
A Phase 3 study testing SEL-212 low-dose and SEL-212 high-dose in people with Chronic Gout, run by Swedish Orphan Biovitrum at 53 sites in 5 countries.
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 and SEL-212 high-dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 53 sitesin 5 countries
- Study dates
- 30 Nov 2020to 12 Jan 2023
- 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 11Show fewer
- > 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)
- 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.
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- 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 037))
- 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
53 sites in 5 countries.
53 sites in 5 countries
United States30 sites
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, 79124
University Of Michigan
Ann Arbor, Michigan, 48109
Injury Care Medical Center
Boise, Idaho, 83713
Great Lakes Clinical Trials at Ravenswood Rheumatology
Chicago, Illinois, 60640
Great Lakes Clinical Trials LLC
Chicago, Illinois, 60640
Clinical Research Of West Florida Incorporated
Clearwater, Florida, 33765
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, 76034
META Medical Research Institute LLC
Dayton, Ohio, 45432
Omegas Research Consultants LLC
DeBary, Florida, 32713
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Horizon Clinical Research
Fayetteville, Georgia, 30214
Arthritis Center of North Georgia, LLC
Gainesville, Georgia, 30501
Medication Management of Greensboro
Greensboro, North Carolina, 27408
Triad Clinical Trials
Greensboro, North Carolina, 27410
Sweet Hope Research Specialty, Inc
Hialeah, Florida, 33016
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Elite Clinical Research, LLC
Jackson, Mississippi, 39202
New Phase Research and Development
Knoxville, Tennessee, 37909
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150
Homestead Associates in Research,Inc
Miami, Florida, 33032
D&H National Research Centers
Miami, Florida, 33155
Panax Clinical Research
Miami Lakes, Florida, 33014
Rutgers- New Jersey Medical School
Newark, New Jersey, 07103
AIM Trials - Internal Medicine
Plano, Texas, 75074
Napa Research
Pompano Beach, Florida, 33064
Carolina Research Center, Inc
Shelby, North Carolina, 28150
Arthritis Northwest, PLLC - Research
Spokane, Washington, 99204
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Conquest Research
Winter Park, Florida, 32789
Georgia6 sites
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0102
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
Tbilisi, 0112
JSC "Evex Hospitals"
Tbilisi, 0159
LTD MediClub Georgia
Tbilisi, 0160
LTD Georgian-Dutch Hospital
Tbilisi, 0172
LTD "The First Medical Center"
Tbilisi, 0180
Russia6 sites
Research Institute of Rheumatology n.a. Nasonova
Moscow, Moscow, 115522
GBOU VPO Orenburg State Medical University
Orenburg, Orenburg Oblast, 460018
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, Kareliya, Respublika, 185019
Ryazan State Medical University n. a. I.P. Pavlov
Ryazan, Ryazan Oblast, 390039
Clinical Rheumatological Hospital #25
Saint Petersburg, Sankt-Peterburg, 190068
Medical-sanitary unit #157 - Rheumatology
Saint Petersburg, Sankt-Peterburg, 196066
Ukraine6 sites
Cherkaska Oblasna likarnia
Cherkasy, 18009
Tovarystvo z obmezhenoi vidpov
Kyiv, Kyïv, 02081
Kyivska klinichna likarnia na
Kyiv, 03049
Naukovo-Doslidnyi Inst. Reabil
Vinnytsia, Vinnytsia Oblast, 21029
Vinnytska Oblasna klinichna likarnia imeni M.I
Vinnytsia, 21018
Medychnyi tsentr Tovarystva z
Zaporizhzhya, Zaporizhzhia Oblast, 69005
Serbia5 sites
Institute for Rheumatology - Rheumatology
Belgrade, 11000
Institute for Rheumatology
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Hospital Center Bezanisjka Kosa
Belgrade, 11080
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, Nišavski Okrug, 18205
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 were 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.
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, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEL-212 low-doseDrug
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) Other Names: SEL-110, ImmTOR
SEL-212 high-doseDrug
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) Other Names: SEL-110, ImmTOR
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| SEL-212 low-dose | Experimental | IV infusion of SEL-212 low-dose every 28 days for a total of up to 6 infusions Receives: Drug: SEL-212 low-dose |
| SEL-212 high-dose | Experimental | IV infusion of SEL-212 high-dose every 28 days for a total of up to 6 infusions Receives: Drug: SEL-212 high-dose |
| Placebo | Placebo comparator | IV infusion of Normal Saline every 28 days for a total of up to 6 infusions Receives: Other: Placebo |
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 contribute 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 two 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 five 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) in overall tophus response evaluation.
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 ITT participants with tophi at baseline divided by the number of ITT 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. Data are presented for the mean change from baseline in number of tender 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 scores 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, with higher scores showing more disability. Data are reported for change from baseline to Month 6 in the total HAQ-DI score. 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 fulfilment 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 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 fulfilment 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 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 posted22 Oct 2020
- Study start30 Nov 2020
- Primary completion10 Jan 2023
- Study completion12 Jan 2023
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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Swedish Orphan Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596540
- Sponsor's protocol ID
- SEL-212/302
- Other IDs
- 2020-003070-45
- Acronym
- DISSOLVE II
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2020
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 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
- NCT04596540
- Acronym / sponsor ID
- DISSOLVE II / SEL-212/302
- Conditions
- Chronic Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 3 Dec 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 were 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.
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-doseIV infusion of SEL-212 low-dose every 28 days for a total of up to 6 infusions |
| SEL-212 high-dose | Experimental | Drug: SEL-212 high-doseIV infusion of SEL-212 high-dose every 28 days for a total of up to 6 infusions |
| Placebo | Placebo comparator | Other: PlaceboIV infusion of Normal Saline every 28 days for a total of up to 6 infusions |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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-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) Other Names: SEL-110, ImmTOR | Drug | SEL-212 low-dose |
| 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) Other Names: SEL-110, ImmTOR | Drug | SEL-212 high-dose |
| PlaceboNormal saline | 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 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Swedish Orphan Biovitrum AB (publ)
53 sites in 5 countries: 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 and SEL-212 high-dose in people with Chronic Gout, run by Swedish Orphan Biovitrum at 53 sites in 5 countries.
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 11 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Georgia, Russia, Ukraine, Serbia. 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 3 Dec 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 3 Dec 2025.