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A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II (DISSOLVE II)

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ClinicalTrials.gov Identifier: NCT04596540
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Selecta Biosciences, Inc.

Brief 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. Approximately 105 patients, stratified as to the presence or absence of tophi, will be 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 (SEL-212/301 and SEL-212/302). Analysis of efficacy will be performed at Day 28 of Treatment Period 6. Safety will be monitored throughout the study.

Condition or disease Intervention/treatment Phase
Chronic Gout Drug: SEL-212A Drug: SEL-212B Other: Placebo Phase 3

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. Approximately 105 patients, stratified as to the presence or absence of tophi, will be 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 (SEL-212/301 and SEL-212/302). The SEL-212 doses will differ as to the SEL-110.36 component. Participants will receive 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-212A) or 0.15 mg/kg (SEL-212B) via IV infusion. The placebo will consist of normal saline.

Placebo subjects who complete the study will be offered enrollment in an open-label extension study for treatment with SEL-212 (SEL-212/303).

Efficacy assessments will be conducted at intervals that are appropriate to determine treatment effect with samples for the primary endpoint drawn during Treatment Period 6. Safety will be monitored throughout the study with an independent data safety monitoring board (DSMB).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: SEL-212A
IV infusion of SEL-212A every 28 days for a total of up to 12 infusions
Drug: SEL-212A

SEL-212A 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


Experimental: SEL-212B
IV infusion of SEL-212B every 28 days for a total of up to 12 infusions
Drug: SEL-212B

SEL-212B 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


Placebo Comparator: Placebo
IV infusion of Normal Saline every 28 days for a total of up to 12 infusions
Other: Placebo
Normal saline




Primary Outcome Measures :
  1. Serum uric acid control during Month 6 [ Time Frame: 6 months ]
    The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo


Secondary Outcome Measures :
  1. Tender and Swollen Joint Counts [ Time Frame: 6 months ]
    To assess changes in number of tender and swollen joints in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

  2. Tophus burden [ Time Frame: 6 months ]
    To assess change in tophus burden by photographic area assessments in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

  3. HAQ-DI [ Time Frame: 6 months ]
    To assess change in Patient Reported Outcomes (PROs) including assessments of activity limitation (HAQ-DI) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

  4. SF-36 [ Time Frame: 6 months ]
    To assess change in Patient Reported Outcomes (PROs) including assessments of patients' quality of life (QoL) (SF-36) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

  5. Gout flare Incidence [ Time Frame: 6 months ]
    To assess changes in gout flare incidence in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for detection of SARS-CoV-2 RNA from a respiratory specimen;
  2. History of symptomatic gout defined as:

    1. ≥ 3 gout flares within 18 months of Screening or
    2. Presence of ≥ 1 gout tophus or
    3. Current diagnosis of gouty arthritis
  3. 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:

    1. > 6 weeks after hysterectomy with or without surgical bilateral salpingo-oophorectomy or
    2. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24 months of amenorrhea, one documented confirmatory FSH measurement)
  4. 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;
  5. Has at the Screening Visit SUA ≥ 7 mg/dL
  6. Negative serology for HIV-1/-2 and negative antigen to hepatitis B and negative antibodies to hepatitis C;

Exclusion Criteria:

  1. Has a history of anaphylaxis, severe allergic reactions, or severe atopy;
  2. 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®);
  3. 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.
  4. 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.
  5. Is a post-menopausal woman that has initiated or had a change in dose of hormone replacement therapy (HRT) less than 1 month prior to the Screening Visit or during the Screening Phase.
  6. 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.
  7. Has uncontrolled diabetes at Screening with HbA1c ≥ 8.5%;
  8. Has fasting Screening glucose > 240 mg/dL;
  9. Has fasting Screening triglyceride > 500 mg/dL;
  10. Has fasting Screening low-density lipoprotein (LDL) > 200 mg/dL;
  11. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency;
  12. Has uncontrolled hypertension defined as blood pressure > 170/100 mmHg at Screening and 1 week prior to dosing
  13. 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) > 3.0
    • Hemoglobin (Hgb) < 9 g/dL
    • Serum phosphate < 2.0 mg/dL
  14. Is receiving ongoing treatment for arrhythmia, including placement of an implantable defibrillator, unless considered stable and on active treatment;
  15. 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;
  16. Has congestive heart failure, New York Heart Association Class III or IV;
  17. 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;
  18. History of significant hematological disorders within 5 years or autoimmune disorders, and/or patient is currently immunosuppressed or immunocompromised;
  19. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®®), pegadricase (SEL 037))
  20. Patient has received a live vaccine in the previous 6 months.
  21. Patient is planning to receive any live vaccine during the study.
  22. History of malignancy within the last 5 years other than basal skin cancer;
  23. Patients with a documented history of moderate or severe alcohol or substance use disorder within the 12 months prior to randomization.
  24. History of or evidence of clinically severe interstitial lung disease
  25. Immunocompromised state, regardless of etiology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596540


Contacts
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Contact: Peter G. Traber, MD 617-923-1400 ptraber@selectabio.com

Locations
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United States, Florida
D&H National Research Centers Recruiting
Miami, Florida, United States, 33155
Contact: Grether Rodriguez    786-375-6210    grdgz@nationalresearchcenters.com   
Napa Research Recruiting
Pompano Beach, Florida, United States, 33064
Contact: Jhonny Bonilla    954-773-9889    jbonilla@napatrials.com   
United States, Georgia
Arthritis Center of North Georgia, LLC Recruiting
Gainesville, Georgia, United States, 30501
Contact: Laura Corn    678-677-8824    lcorn@articularishealthcare.com   
United States, Idaho
Injury Care Medical Center Recruiting
Boise, Idaho, United States, 83713
Contact: Bridget Venard    208-939-2100    bridget@injurycareresearch.com   
United States, Illinois
Great Lakes Clinical Trials at Ravenswood Rheumatology Recruiting
Chicago, Illinois, United States, 60640
Contact: Zander Schrempp    773-275-3500    zschrempp@greatlakesclinicaltrials.com   
Great Lakes Clinical Trials LLC Recruiting
Chicago, Illinois, United States, 60640
Contact: Jim Miedema    773-275-3500    jmiedema@greatlakesclinicaltrials.com   
United States, Maryland
The Center for Rheumatology and Bone Research Recruiting
Wheaton, Maryland, United States, 20902
Contact: Megan Lormore    301-942-6610    mlormore@arapc.com   
United States, North Carolina
Triad Clinical Trials Recruiting
Greensboro, North Carolina, United States, 27410
Contact: Shavonna Haamid    336-235-0991    s.haamid@triad.twcbc.com   
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Lisa Claycomb    814-693-0300 ext 124    altoonaresearch@gmail.com   
United States, Texas
Amarillo Center for Clinical Research, Ltd. Recruiting
Amarillo, Texas, United States, 79124
Contact: Casey Mizer    806-352-2453    cmizer@allergyarts.com   
Heritage Rheumatology and Arthritis Care Recruiting
Colleyville, Texas, United States, 76034
Contact: Chudi Nwoye    972-299-8399    chudinwoye@pccrsolutions.com   
United States, Washington
Arthritis Northwest, PLLC - Research Recruiting
Spokane, Washington, United States, 99204
Contact: Seinna Gray    509-838-6500 ext 320    sgray@arthritisnw.com   
Georgia
LTD Israeli-Georgian Medical Research Clinic "Helsicore" Recruiting
Tbilisi, Georgia, 0112
Contact: Ketevan Gabunia, MD    995 599 577 977    keti.gab23@gmail.com   
JSC "Evex Hospitals" Recruiting
Tbilisi, Georgia, 0159
Contact: Nina Tskhovrebashvili, MD    +995599147085    ninatskhovreba@mail.ru   
LTD MediClub Georgia Recruiting
Tbilisi, Georgia, 0160
Contact: David Gochitashvili    +995599510806    d.gochitashvili@mcg.ge   
LTD "The First Medical Center" Recruiting
Tbilisi, Georgia, 0180
Contact: Besik Tsintsadze    +995 558 100 725    b.tsintsadze95@gmail.com   
Sponsors and Collaborators
Selecta Biosciences, Inc.
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Responsible Party: Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04596540    
Other Study ID Numbers: SEL-212/302
2020-003070-45 ( EudraCT Number )
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases