Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Gout

Outcome Measures

Primary Outcomes (1)

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)
Month 6

Secondary Outcomes (9)

Change From Baseline in Mean sUA
Baseline up to 6 months
Percentage Change From Baseline in Mean sUA
Baseline up to 6 months
Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36)
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 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
Baseline up to 6 months
+4 more secondary outcomes

Study Arms (3)

SEL-212 low-dose

EXPERIMENTAL

IV infusion of SEL-212 low-dose every 28 days for a total of up to 6 infusions

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

Drug: SEL-212 high-dose

Placebo

PLACEBO COMPARATOR

IV infusion of Normal Saline every 28 days for a total of up to 6 infusions

Other: Placebo

Interventions

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 low-dose

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

Eligibility Criteria

Age19 Years - 80 Years

Sexall(Gender-based eligibility)

Gender Eligibility Detailsfemale 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)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;

Sponsors & Collaborators

Swedish Orphan Biovitrum
Industrylead

Study Sites (53)

Clinical Research Of West Florida Incorporated

Clearwater, Florida, 33765, United States

Omegas Research Consultants LLC

DeBary, Florida, 32713, United States

Sweet Hope Research Specialty, Inc

Hialeah, Florida, 33016, United States

Homestead Associates in Research,Inc

Miami, Florida, 33032, United States

D&H National Research Centers

Miami, Florida, 33155, United States

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Napa Research

Pompano Beach, Florida, 33064, United States

Results Point of Contact

Title: Blank Clinical Study Physician, MD
Organization: Swedish Orphan Biovitrum AB (publ)

Study Officials

Medical Director
Swedish Orphan Biovitrum AB (publ)
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

153 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

November 30, 2020

Actual (reported)

You may not qualify if:

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
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
+15 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

SEL-212 low-dose

SEL-212 high-dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (53)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

SEL-212 low-dose

SEL-212 high-dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (53)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations