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

PHASE3CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

January 10, 2023

Study Completion Date

January 12, 2023

Conditions
Chronic Gout
Interventions
DRUG

SEL-212 low-dose

"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"

DRUG

SEL-212 high-dose

"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"

OTHER

Placebo

Normal saline

Trial Locations (53)

11000

Institute for Rheumatology - Rheumatology, Belgrade

Institute for Rheumatology, Belgrade

Military Medical Academy, Belgrade

11080

Clinical Hospital Center Bezanisjka Kosa, Belgrade

16635

Altoona Center for Clinical Research, Duncansville

18009

Cherkaska Oblasna likarnia, Cherkasy

18205

Institute for Treatment and Rehabilitation Niska Banja, Niška Banja

20902

The Center for Rheumatology and Bone Research, Wheaton

21018

Vinnytska Oblasna klinichna likarnia imeni M.I, Vinnytsia

21029

Naukovo-Doslidnyi Inst. Reabil, Vinnytsia

27408

Medication Management of Greensboro, Greensboro

27410

Triad Clinical Trials, Greensboro

28150

Carolina Research Center, Inc, Shelby

30214

Horizon Clinical Research, Fayetteville

30501

Arthritis Center of North Georgia, LLC, Gainesville

32713

Omegas Research Consultants LLC, DeBary

32789

Conquest Research, Winter Park

33014

Panax Clinical Research, Miami Lakes

33016

Sweet Hope Research Specialty, Inc, Hialeah

33032

Homestead Associates in Research,Inc, Miami

33064

Napa Research, Pompano Beach

33155

D&H National Research Centers, Miami

33606

Clinical Research of West Florida, Inc., Tampa

33765

Clinical Research Of West Florida Incorporated, Clearwater

37909

New Phase Research and Development, Knoxville

39202

Elite Clinical Research, LLC, Jackson

45432

META Medical Research Institute LLC, Dayton

48109

University Of Michigan, Ann Arbor

60640

Great Lakes Clinical Trials at Ravenswood Rheumatology, Chicago

Great Lakes Clinical Trials LLC, Chicago

69005

Medychnyi tsentr Tovarystva z, Zaporizhzhia

75074

AIM Trials - Internal Medicine, Plano

75150

Southwest Rheumatology Research LLC, Mesquite

76034

Heritage Rheumatology and Arthritis Care, Colleyville

77099

Pioneer Research Solutions, Inc., Houston

79124

Amarillo Center for Clinical Research, Ltd., Amarillo

83713

Injury Care Medical Center, Boise

99204

Arthritis Northwest, PLLC - Research, Spokane

115522

Research Institute of Rheumatology n.a. Nasonova, Moscow

185019

Republican Hospital n.a. V.A. Baranov, Petrozavodsk

190068

Clinical Rheumatological Hospital #25, Saint Petersburg

196066

Medical-sanitary unit #157 - Rheumatology, Saint Petersburg

390039

Ryazan State Medical University n. a. I.P. Pavlov, Ryazan

460018

GBOU VPO Orenburg State Medical University, Orenburg

07103

Rutgers- New Jersey Medical School, Newark

0102

Aleksandre Aladashvili Clinic LLC, Tbilisi

0112

"LTD Israeli-Georgian Medical Research Clinic Helsicore", Tbilisi

0159

"JSC Evex Hospitals", Tbilisi

0160

LTD MediClub Georgia, Tbilisi

0172

LTD Georgian-Dutch Hospital, Tbilisi

0180

"LTD The First Medical Center", Tbilisi

02081

Tovarystvo z obmezhenoi vidpov, Kyiv

03049

Kyivska klinichna likarnia na, Kyiv

Sponsors
All Listed Sponsors
lead

Swedish Orphan Biovitrum

INDUSTRY

NCT04596540 - A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II | Biotech Hunter | Biotech Hunter