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

Primary Purpose

Chronic Gout

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SEL-212 low-dose
SEL-212 high-dose
Normal Saline
Sponsored by
Selecta Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Gout

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    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:

    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)

  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. 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
  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

Sites / Locations

  • Pinnacle Research Group
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Medvin Clinical Research
  • Valerius Medical Group & Research Center
  • ACRC Studies
  • MD Strategies Research Center
  • Tekton Research - Fort Collins
  • Helix Biomedics, LLC
  • Clinical Research Of West Florida Incorporated
  • Omegas Research Consultants LLC
  • Riverside Clinical Research
  • Homestead Associates in Research,Inc
  • Health Awareness INC
  • Panax Clinical Research
  • Y & L Advance Health Care, Inc
  • Well Pharma Medical Research, Corp
  • Clinical Research of West Florida, Inc.
  • Conquest Research
  • Better Health Clinical Research, Inc.
  • Institute of Arthritis Research
  • Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
  • L-MARC Research Center
  • Reseach Integrity, LLC
  • Klein and Associates, M.D., P.A.
  • Klein and Associates, M.D., P.A.
  • Clinical Pharmacology Study Group
  • Elite Clinical Research, LLC
  • Arthritis Consultants, Inc.
  • Montana Medical Research, Inc.
  • Medex Healthcare Research, Inc.
  • CFA - Cape Fear Arthritis Care, PLLC
  • New Horizons Clinical Research
  • Arthritis & Rheumatology Center of Oklahoma, PLLC
  • West Tennessee Research Institute
  • Metroplex Clinical Research Center
  • Pioneer Research Solutions, Inc.
  • Southwest Rheumatology Research LLC
  • AIM Trials - Internal Medicine
  • Epic Medical Research
  • Clinical Research Partners, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SEL-212 low-dose

SEL-212 high-dose

Placebo

Arm Description

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 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

Normal saline

Outcomes

Primary Outcome Measures

Serum uric acid control during month 6
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

Reduction of mean serum uric acid
To assess changes in mean serum uric acid in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Percent reduction of mean serum uric acid
To assess percent changes in mean serum uric acid in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
SF-36
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
Tophus burden
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
Serum uric acid control in patients with tophi
To assess change in the percentage of patients with tophi at baseline 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
Tender and Swollen Joint Counts
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
HAQ-DI
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
Gout Flare Incidence
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

Full Information

First Posted
August 7, 2020
Last Updated
July 12, 2023
Sponsor
Selecta Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04513366
Brief Title
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Acronym
DISSOLVE I
Official Title
A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Selecta Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. 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 will be 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 hig-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. Placebo subjects who completed 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEL-212 low-dose
Arm Type
Experimental
Arm Description
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
Arm Title
SEL-212 high-dose
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
SEL-212 low-dose
Intervention Description
IV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions
Intervention Type
Drug
Intervention Name(s)
SEL-212 high-dose
Intervention Description
IV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
IV infusion of Normal Saline every 28 days for a total of up to 12 infusions
Primary Outcome Measure Information:
Title
Serum uric acid control during month 6
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction of mean serum uric acid
Description
To assess changes in mean serum uric acid in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Time Frame
6 months
Title
Percent reduction of mean serum uric acid
Description
To assess percent changes in mean serum uric acid in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Time Frame
6 months
Title
SF-36
Description
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
Time Frame
6 months
Title
Tophus burden
Description
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
Time Frame
6 months
Title
Serum uric acid control in patients with tophi
Description
To assess change in the percentage of patients with tophi at baseline 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
Time Frame
6 months
Title
Tender and Swollen Joint Counts
Description
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
Time Frame
6 months
Title
HAQ-DI
Description
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
Time Frame
6 months
Title
Gout Flare Incidence
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
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)
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: ≥ 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: 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 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
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Valerius Medical Group & Research Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
ACRC Studies
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
MD Strategies Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Tekton Research - Fort Collins
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Helix Biomedics, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Clinical Research Of West Florida Incorporated
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Omegas Research Consultants LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Homestead Associates in Research,Inc
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Health Awareness INC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Y & L Advance Health Care, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Well Pharma Medical Research, Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Reseach Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Klein and Associates, M.D., P.A.
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Klein and Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Elite Clinical Research, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Arthritis Consultants, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montana Medical Research, Inc.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
CFA - Cape Fear Arthritis Care, PLLC
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma, PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
AIM Trials - Internal Medicine
City
Plano
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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