The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 70 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04877691 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AstraZeneca |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Bulgaria, Chile, Colombia, Germany, Hungary, Japan, Mexico, Peru, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age. Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the primary endpoint evaluated at Week 52. Subjects who complete Week 52 may enter into open-label extension (OLE). All patients who enter the OLE Period will receive a fixed subcutaneous dose of anifrolumab for up to 52 weeks. Study intervention will be administered SC via an accessorised prefilled syringe (aPFS).
Experimental: Anifrolumab
Solution for injection in aPFS
Placebo Comparator: Placebo
Solution for injection in aPFS
Drug: - Medi-546
Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration.
Drug: - Placebo
Solution for injection in aPFS
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Withdrawn
Address
Research Site
Anniston, Alabama, 36207
Status
Recruiting
Address
Research Site
Birmingham, Alabama, 35233
Status
Recruiting
Address
Research Site
Paradise Valley, Arizona, 85253
Status
Recruiting
Address
Research Site
Phoenix, Arizona, 85032
Status
Recruiting
Address
Research Site
El Cajon, California, 92020
Status
Recruiting
Address
Research Site
Hemet, California, 92543
Status
Recruiting
Address
Research Site
La Mesa, California, 91942
Status
Recruiting
Address
Research Site
Los Angeles, California, 90095
Status
Recruiting
Address
Research Site
Menifee, California, 92586
Status
Recruiting
Address
Research Site
Moreno Valley, California, 92553
Status
Recruiting
Address
Research Site
Upland, California, 91786
Status
Recruiting
Address
Research Site
Aurora, Colorado, 80045
Status
Recruiting
Address
Research Site
Denver, Colorado, 80230
Status
Recruiting
Address
Research Site
Boynton Beach, Florida, 33472
Status
Recruiting
Address
Research Site
Brandon, Florida, 33511
Status
Recruiting
Address
Research Site
Clearwater, Florida, 33759
Status
Active, not recruiting
Address
Research Site
Clearwater, Florida, 33765
Status
Withdrawn
Address
Research Site
Hialeah, Florida, 33016
Status
Recruiting
Address
Research Site
Miami, Florida, 33180
Status
Not yet recruiting
Address
Research Site
Tampa, Florida, 33606
Status
Completed
Address
Research Site
Tampa, Florida, 33613
Status
Withdrawn
Address
Research Site
Tampa, Florida, 33613
Status
Recruiting
Address
Research Site
Tampa, Florida, 33614
Status
Recruiting
Address
Research Site
Decatur, Georgia, 30033
Status
Not yet recruiting
Address
Research Site
Lawrenceville, Georgia, 30046
Status
Completed
Address
Research Site
Idaho Falls, Idaho, 83404
Status
Recruiting
Address
Research Site
Boston, Massachusetts, 02215
Status
Recruiting
Address
Research Site
Flint, Michigan, 48504
Status
Recruiting
Address
Research Site
Saint Louis, Missouri, 63119
Status
Recruiting
Address
Research Site
Newark, New Jersey, 07103
Status
Recruiting
Address
Research Site
Voorhees, New Jersey, 08043
Status
Recruiting
Address
Research Site
Las Cruces, New Mexico, 88011
Status
Not yet recruiting
Address
Research Site
Bronx, New York, 10461
Status
Recruiting
Address
Research Site
Brooklyn, New York, 11201
Status
Recruiting
Address
Research Site
Manhasset, New York, 11030
Status
Recruiting
Address
Research Site
New Hyde Park, New York, 11042
Status
Recruiting
Address
Research Site
New York, New York, 10032
Status
Recruiting
Address
Research Site
Potsdam, New York, 13676
Status
Recruiting
Address
Research Site
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Research Site
Charlotte, North Carolina, 28204
Status
Recruiting
Address
Research Site
Oklahoma City, Oklahoma, 73104
Status
Recruiting
Address
Research Site
Pittsburgh, Pennsylvania, 15224
Status
Completed
Address
Research Site
Reading, Pennsylvania, 19610
Status
Recruiting
Address
Research Site
Memphis, Tennessee, 38119
Status
Withdrawn
Address
Research Site
Austin, Texas, 78745
Status
Not yet recruiting
Address
Research Site
El Paso, Texas, 79902
Status
Completed
Address
Research Site
Grapevine, Texas, 76051
Status
Recruiting
Address
Research Site
Ciudad de Buenos Aires, , C1431FWO
Status
Withdrawn
Address
Research Site
Córdoba, , X5016KEH
Status
Active, not recruiting
Address
Research Site
La Plata, , 1900
Status
Recruiting
Address
Research Site
Mendoza, , 5500
Status
Active, not recruiting
Address
Research Site
Pergamino, , B2700CPM
Status
Recruiting
Address
Research Site
Quilmes, , B1878GEG
Status
Recruiting
Address
Research Site
Rosario, , S2000PBJ
Status
Recruiting
Address
Research Site
Salta, , A4400ANW
Status
Recruiting
Address
Research Site
San Isidro, , 1643
Status
Recruiting
Address
Research Site
San Juan, , 5400
Status
Recruiting
Address
Research Site
San Miguel de Tucuman, , 4000
Status
Recruiting
Address
Research Site
San Miguel de Tucuman, , T4000AXL
Status
Recruiting
Address
Research Site
San Miguel de Tucuman, , T4000ICL
Status
Recruiting
Address
Research Site
Kardzhali, , 6600
Status
Recruiting
Address
Research Site
Pleven, , 5800
Status
Active, not recruiting
Address
Research Site
Plovdiv, , 4003
Status
Active, not recruiting
Address
Research Site
Sevlievo, , 5400
Status
Active, not recruiting
Address
Research Site
Sofia, , 1431
Status
Active, not recruiting
Address
Research Site
Sofia, , 1784
Status
Active, not recruiting
Address
Research Site
Sofia, , 1797
Status
Completed
Address
Research Site
Osorno, , 5290000
Status
Recruiting
Address
Research Site
Santiago, , 7500010
Status
Recruiting
Address
Research Site
Santiago, , 7500571
Status
Completed
Address
Research Site
Santiago, , 7500588
Status
Recruiting
Address
Research Site
Santiago, , 7500710
Status
Recruiting
Address
Research Site
Santiago, , 7501126
Status
Recruiting
Address
Research Site
Santiago, , 8320000
Status
Completed
Address
Research Site
Valdivia, , 5090000
Status
Recruiting
Address
Research Site
Barranquilla, , 080002
Status
Recruiting
Address
Research Site
Barranquilla, , 080020
Status
Recruiting
Address
Research Site
Bogota, , 110221
Status
Withdrawn
Address
Research Site
Bucaramanga, , 680003
Status
Recruiting
Address
Research Site
Bucaramanga, , 680003
Status
Recruiting
Address
Research Site
Chia, , 250001
Status
Withdrawn
Address
Research Site
Medellin, , 050034
Status
Recruiting
Address
Research Site
Monteria, , 230002
Status
Recruiting
Address
Research Site
Berlin, , 10117
Status
Recruiting
Address
Research Site
Berlin, , D-10117
Status
Recruiting
Address
Research Site
Dresden, , 01067
Status
Withdrawn
Address
Research Site
Kirchheim, , 73230
Status
Recruiting
Address
Research Site
Leipzig, , 04103
Status
Recruiting
Address
Research Site
Tuebingen, , 72076
Status
Recruiting
Address
Research Site
Budapest, , 1027
Status
Recruiting
Address
Research Site
Budapest, , 1036
Status
Recruiting
Address
Research Site
Budapest, , 1097
Status
Recruiting
Address
Research Site
Szekesfehervar, , 8000
Status
Completed
Address
Research Site
Veszprem, , 8200
Status
Recruiting
Address
Research Site
Chiba-shi, , 260-8712
Status
Recruiting
Address
Research Site
Chuo-ku, , 104-8560
Status
Recruiting
Address
Research Site
Hamamatsu-shi, , 430-0906
Status
Recruiting
Address
Research Site
Hamamatsu-shi, , 431-3192
Status
Recruiting
Address
Research Site
Hiroshima-shi, , 734-8551
Status
Recruiting
Address
Research Site
Itabashi-ku, , 173-8610
Status
Recruiting
Address
Research Site
Kawasaki-shi, , 216-8511
Status
Recruiting
Address
Research Site
Kita-gun, , 761-0793
Status
Recruiting
Address
Research Site
Kitakyushu-shi, , 807-8555
Status
Recruiting
Address
Research Site
Meguro-ku, , 152-8902
Status
Recruiting
Address
Research Site
Meguro-ku, , 153-8515
Status
Recruiting
Address
Research Site
Nagasaki-shi, , 852-8501
Status
Recruiting
Address
Research Site
Nagoya-shi, , 460-0001
Status
Recruiting
Address
Research Site
Nagoya, , 457-8510
Status
Recruiting
Address
Research Site
Okayama-shi, , 700-8558
Status
Recruiting
Address
Research Site
Okayama-shi, , 700-8607
Status
Recruiting
Address
Research Site
Sagamihara-shi, , 252-0375
Status
Recruiting
Address
Research Site
Sapporo-shi, , 060-8543
Status
Recruiting
Address
Research Site
Sasebo-shi, , 857-1195
Status
Recruiting
Address
Research Site
Sendai-shi, , 980-8574
Status
Recruiting
Address
Research Site
Shinjuku-ku, , 160-8582
Status
Recruiting
Address
Research Site
Suita-shi, , 565-0871
Status
Recruiting
Address
Research Site
Takatsuki-shi, , 569-8686
Status
Recruiting
Address
Research Site
Tsu-shi, , 514-8507
Status
Recruiting
Address
Research Site
Tsukuba-shi, , 305-8576
Status
Recruiting
Address
Research Site
Chihuahua, , 31000
Status
Recruiting
Address
Research Site
Culiacan, , 80000
Status
Recruiting
Address
Research Site
Durango, , 43080
Status
Recruiting
Address
Research Site
Guadalajara, , 44130
Status
Active, not recruiting
Address
Research Site
Guadalajara, , 44650
Status
Recruiting
Address
Research Site
Guadalajara, , 44950
Status
Recruiting
Address
Research Site
Merida, , 97000
Status
Active, not recruiting
Address
Research Site
Merida, , 97070
Status
Recruiting
Address
Research Site
Mexicali, , 21200
Status
Recruiting
Address
Research Site
Mexico, , 03100
Status
Recruiting
Address
Research Site
Mexico, , 03720
Status
Recruiting
Address
Research Site
Mexico, , 06700
Status
Withdrawn
Address
Research Site
Lima, , LIMA 11
Status
Withdrawn
Address
Research Site
Lima, , LIMA 29
Status
Withdrawn
Address
Research Site
Lima, , LIMA 32
Status
Withdrawn
Address
Research Site
Lima, , LIMA 41
Status
Recruiting
Address
Research Site
Katowice, , 40-081
Status
Recruiting
Address
Research Site
Koscian, , 64-000
Status
Recruiting
Address
Research Site
Krakow, , 30-033
Status
Recruiting
Address
Research Site
Krakow, , 30-363
Status
Active, not recruiting
Address
Research Site
Kraków, , 30-510
Status
Recruiting
Address
Research Site
Lublin, , 20-607
Status
Recruiting
Address
Research Site
Nowa Sól, , 67-100
Status
Recruiting
Address
Research Site
Ustron, , 43-450
Status
Recruiting
Address
Research Site
Warszawa, , 00-874
Status
Recruiting
Address
Research Site
Warszawa, , 02-118
Status
Recruiting
Address
Research Site
Warszawa, , 02-691
Status
Active, not recruiting
Address
Research Site
Wroclaw, , 50-088
Status
Recruiting
Address
Research Site
Wroclaw, , 50-244
Status
Recruiting
Address
Research Site
Łódź, , 90-368
Status
Withdrawn
Address
Research Site
Moscow, , 115522
Status
Withdrawn
Address
Research Site
Moscow, , 119021
Status
Withdrawn
Address
Research Site
Ryazan, , 390026
Status
Withdrawn
Address
Research Site
Saint-Petersburg, , 190068
Status
Withdrawn
Address
Research Site
Saratov, , 410054
Status
Withdrawn
Address
Research Site
Smolensk, , 214015
Status
Active, not recruiting
Address
Research Site
Barcelona, , 08036
Status
Recruiting
Address
Research Site
Barcelona, , 8003
Status
Recruiting
Address
Research Site
Barcelona, , 8035
Status
Recruiting
Address
Research Site
Madrid, , 28050
Status
Recruiting
Address
Research Site
Madrid, , 28702
Status
Active, not recruiting
Address
Research Site
Santiago de Compostela, , 15706
Status
Recruiting
Address
Research Site
Sevilla, , 41010
Status
Recruiting
Address
Research Site
Valencia, , 46026
Status
Suspended
Address
Research Site
Cherkasy, , 18009
Status
Suspended
Address
Research Site
Kryvyi Rih, , 50031
Status
Not yet recruiting
Address
Research Site
Lviv, , 79000
Status
Not yet recruiting
Address
Research Site
Odesa, , 65026
Status
Recruiting
Address
Research Site
Vinnytsia, , 21001
Status
Recruiting
Address
Research Site
Vinnytsia, , 21029
Status
Suspended
Address
Research Site
Zaporizhzhia, , 69600
Status
Recruiting
Address
Research Site
Coventry, , CV2 2DX
Status
Recruiting
Address
Research Site
Doncaster, , DN2 5LT
Status
Recruiting
Address
Research Site
Edinburgh, , EH4 2XU
Status
Recruiting
Address
Research Site
Harlow, , CM20 1QX
Status
Not yet recruiting
Address
Research Site
Leeds, , LS7 4SA
Status
Withdrawn
Address
Research Site
Leytonstone, , E11 1NR
Status
Recruiting
Address
Research Site
London, , SE1 9RT
Status
Not yet recruiting
Address
Research Site
London, , SE5 9NU
Status
Recruiting
Address
Research Site
Wigan, , WN6 9EP