153
Participants
Start Date
November 30, 2020
Primary Completion Date
January 10, 2023
Study Completion Date
January 12, 2023
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"
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"
Placebo
Normal saline
Institute for Rheumatology - Rheumatology, Belgrade
Institute for Rheumatology, Belgrade
Military Medical Academy, Belgrade
Clinical Hospital Center Bezanisjka Kosa, Belgrade
Altoona Center for Clinical Research, Duncansville
Cherkaska Oblasna likarnia, Cherkasy
Institute for Treatment and Rehabilitation Niska Banja, Niška Banja
The Center for Rheumatology and Bone Research, Wheaton
Vinnytska Oblasna klinichna likarnia imeni M.I, Vinnytsia
Naukovo-Doslidnyi Inst. Reabil, Vinnytsia
Medication Management of Greensboro, Greensboro
Triad Clinical Trials, Greensboro
Carolina Research Center, Inc, Shelby
Horizon Clinical Research, Fayetteville
Arthritis Center of North Georgia, LLC, Gainesville
Omegas Research Consultants LLC, DeBary
Conquest Research, Winter Park
Panax Clinical Research, Miami Lakes
Sweet Hope Research Specialty, Inc, Hialeah
Homestead Associates in Research,Inc, Miami
Napa Research, Pompano Beach
D&H National Research Centers, Miami
Clinical Research of West Florida, Inc., Tampa
Clinical Research Of West Florida Incorporated, Clearwater
New Phase Research and Development, Knoxville
Elite Clinical Research, LLC, Jackson
META Medical Research Institute LLC, Dayton
University Of Michigan, Ann Arbor
Great Lakes Clinical Trials at Ravenswood Rheumatology, Chicago
Great Lakes Clinical Trials LLC, Chicago
Medychnyi tsentr Tovarystva z, Zaporizhzhia
AIM Trials - Internal Medicine, Plano
Southwest Rheumatology Research LLC, Mesquite
Heritage Rheumatology and Arthritis Care, Colleyville
Pioneer Research Solutions, Inc., Houston
Amarillo Center for Clinical Research, Ltd., Amarillo
Injury Care Medical Center, Boise
Arthritis Northwest, PLLC - Research, Spokane
Research Institute of Rheumatology n.a. Nasonova, Moscow
Republican Hospital n.a. V.A. Baranov, Petrozavodsk
Clinical Rheumatological Hospital #25, Saint Petersburg
Medical-sanitary unit #157 - Rheumatology, Saint Petersburg
Ryazan State Medical University n. a. I.P. Pavlov, Ryazan
GBOU VPO Orenburg State Medical University, Orenburg
Rutgers- New Jersey Medical School, Newark
Aleksandre Aladashvili Clinic LLC, Tbilisi
"LTD Israeli-Georgian Medical Research Clinic Helsicore", Tbilisi
"JSC Evex Hospitals", Tbilisi
LTD MediClub Georgia, Tbilisi
LTD Georgian-Dutch Hospital, Tbilisi
"LTD The First Medical Center", Tbilisi
Tovarystvo z obmezhenoi vidpov, Kyiv
Kyivska klinichna likarnia na, Kyiv
Lead Sponsor
Swedish Orphan Biovitrum
INDUSTRY