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DISSOLVE I: A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

Sponsor
Selecta Biosciences, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04513366
Collaborator
(none)
120
Enrollment
40
Locations
3
Arms
25.4
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 120 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
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 120 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.

Upon completion of the 6-month double-blinded, placebo-controlled portion of the study, SEL-212/301 will continue in a blinded, placebo-controlled 6-month extension. This will provide up to 12 months of continuous treatment with SEL-212 in a placebo controlled fashion.

Subjects who complete both phases of 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 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 :
Aug 18, 2020
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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) SEL-110.36, ImmTOR

Drug: SEL-212A
IV infusion of SEL-212A every 28 days for a total of up to 12 infusions
Experimental: 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) SEL-110.36, ImmTOR

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

Normal saline

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

Outcome Measures

Primary Outcome Measures

  1. Serum uric acid control during month 6 [6 months]

    The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/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 [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 [6 months]

    To assess change in tophus burden by photographic area assessment in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo

  3. HAQ-DI [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 nasal or oropharyngeal specimen;

  2. History of symptomatic gout defined as:

  3. ≥ 3 gout flares within 18 months of Screening or

  4. Presence of ≥ 1 gout tophus or

  5. Current diagnosis of gouty arthritis

  6. 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 salpingooperhectony or b. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24 months of amenorrhea, one documented confirmatory FSH measurement)

  1. 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;

  2. Has at the Screening Visit SUA ≥ 7 mg/dL

  3. 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. Had major surgery within 3 months of initial screening.

  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) > 30 mg/g

  • Hemoglobin (Hgb) < 9 g/dL

  • Serum phosphate < 2.0 mg/dL

  1. Is receiving ongoing treatment for arrhythmia, including placement of an implantable defibrillator, unless considered stable and on active treatment;

  2. 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;

  3. Has congestive heart failure, New York Heart Association Class III or IV;

  4. 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;

  5. History of significant hematological disorders within 5 years or autoimmune disorders, and/or patient is currently immunosuppressed or immunocompromised;

  6. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®®), pegadricase (SEL 037))

  7. Patient has received a live vaccine in the previous 6 months.

  8. Patient is planning to receive any live vaccine during the study.

  9. History of malignancy within the last 5 years other than basal skin cancer;

  10. Patients with a documented history of moderate or severe alcohol or substance use disorder within the 12 months prior to randomization.

  11. History of or evidence of clinically severe interstitial lung disease

  12. Immunocompromised state, regardless of etiology

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pinnacle Research Group Anniston Alabama United States 36207
2 Arizona Arthritis & Rheumatology Research, PLLC Sun City Arizona United States 85351
3 Medvin Clinical Research Covina California United States 91722
4 Valerius Medical Group & Research Center Los Alamitos California United States 90720
5 ACRC Studies Poway California United States 92064
6 MD Strategies Research Center San Diego California United States 92119
7 Tekton Research - Fort Collins Fort Collins Colorado United States 80528
8 Helix Biomedics, LLC Boynton Beach Florida United States 33435
9 Clinical Research Of West Florida Incorporated Clearwater Florida United States 33765
10 Omegas Research Consultants LLC DeBary Florida United States 32713
11 Riverside Clinical Research Edgewater Florida United States 32132
12 Homestead Associates in Research,Inc Homestead Florida United States 33032
13 Health Awareness INC Jupiter Florida United States 33458
14 Panax Clinical Research Miami Lakes Florida United States 33014
15 Y & L Advance Health Care, Inc Miami Florida United States 33144
16 Well Pharma Medical Research, Corp Miami Florida United States 33173
17 Clinical Research of West Florida, Inc. Tampa Florida United States 33606
18 Conquest Research Winter Park Florida United States 32789
19 Better Health Clinical Research, Inc. Newnan Georgia United States 30265
20 Institute of Arthritis Research Idaho Falls Idaho United States 83404
21 Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian Meridian Idaho United States 83642
22 L-MARC Research Center Louisville Kentucky United States 40213
23 Reseach Integrity, LLC Owensboro Kentucky United States 42303
24 Klein and Associates, M.D., P.A. Cumberland Maryland United States 21502
25 Klein and Associates, M.D., P.A. Hagerstown Maryland United States 21740
26 Clinical Pharmacology Study Group Worcester Massachusetts United States 01605
27 Elite Clinical Research, LLC Jackson Mississippi United States 39216
28 Arthritis Consultants, Inc. Saint Louis Missouri United States 63141
29 Montana Medical Research, Inc. Missoula Montana United States 59808
30 Medex Healthcare Research, Inc. New York New York United States 10036
31 CFA - Cape Fear Arthritis Care, PLLC Leland North Carolina United States 28451
32 New Horizons Clinical Research Cincinnati Ohio United States 45242
33 Arthritis & Rheumatology Center of Oklahoma, PLLC Oklahoma City Oklahoma United States 73102
34 West Tennessee Research Institute Jackson Tennessee United States 38305
35 Metroplex Clinical Research Center Dallas Texas United States 75231
36 Pioneer Research Solutions, Inc. Houston Texas United States 77099
37 Southwest Rheumatology Research LLC Mesquite Texas United States 75150
38 AIM Trials - Internal Medicine Plano Texas United States 75234
39 Epic Medical Research Red Oak Texas United States 75154
40 Clinical Research Partners, LLC Richmond Virginia United States 23220

Sponsors and Collaborators

  • Selecta Biosciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT04513366
Other Study ID Numbers:
  • SEL-212/301
First Posted:
Aug 14, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gout

Study Results

No Results Posted as of Apr 5, 2022