- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446899
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous 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 corticosteroids (OCS), antimalarial, and/or immunosuppressants. The study will be performed in adult participants aged 18 to 70 years of age.
Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed intravenous dose of anifrolumab 300 mg or placebo every 4 weeks for a total of 13 doses (Week 0 to Week 48), with the primary endpoint evaluated at the Week 52 visit. Investigational product will be administered as an intravenous infusion (IV) via an infusion pump over a minimum of 30 minutes, every 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Buenos Aires, Argentina, C1015ABO
- Research Site
-
Mendoza, Argentina, 5500
- Research Site
-
Quilmes, Argentina, 1878
- Research Site
-
-
-
-
-
Bruxelles, Belgium, 1070
- Research Site
-
Leuven, Belgium, 3000
- Research Site
-
Liege, Belgium, B-4000
- Research Site
-
Merksem, Belgium, B-2170
- Research Site
-
-
-
-
-
Goiania, Brazil, 74110-120
- Research Site
-
Juiz de Fora, Brazil, 36010 570
- Research Site
-
Sao Paulo, Brazil, 04032-060
- Research Site
-
Sao Paulo, Brazil, 05403-9000
- Research Site
-
Sao Paulo, Brazil, 05652-900
- Research Site
-
-
-
-
-
Plovdiv, Bulgaria, 4003
- Research Site
-
Plovdiv, Bulgaria, 4002
- Research Site
-
-
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4K1
- Research Site
-
-
Quebec
-
Rimouski, Quebec, Canada, G5L 5T1
- Research Site
-
-
-
-
-
Bordeaux, France, 33000
- Research Site
-
Lille, France, 59037
- Research Site
-
Montpellier CEDEX 5, France, 34295
- Research Site
-
Paris, France, 75679
- Research Site
-
Paris, France, 75651
- Research Site
-
Pessac, France, 33604
- Research Site
-
Toulouse, France, 31000
- Research Site
-
-
-
-
-
Berlin, Germany, D-10117
- Research Site
-
Hamburg, Germany, 20246
- Research Site
-
Jena, Germany, 07747
- Research Site
-
Mainz, Germany, 55131
- Research Site
-
München, Germany, 80336
- Research Site
-
-
-
-
-
Chiba-shi, Japan, 260-8712
- Research Site
-
Chuo-ku, Japan, 104-8560
- Research Site
-
Fukuoka-shi, Japan, 810-8563
- Research Site
-
Fukuoka-shi, Japan, 810-8539
- Research Site
-
Hiroshima-shi, Japan, 730-8619
- Research Site
-
Kitakyushu-shi, Japan, 807-8555
- Research Site
-
Kurashiki-shi, Japan, 710-8522
- Research Site
-
Meguro-ku, Japan, 152-8902
- Research Site
-
Meguro-ku, Japan, 153-8515
- Research Site
-
Nagasaki-shi, Japan, 852-8501
- Research Site
-
Nagoya-shi, Japan, 460-0001
- Research Site
-
Omura-shi, Japan, 856-8562
- Research Site
-
Sapporo-shi, Japan, 060-8638
- Research Site
-
Sasebo-shi, Japan, 857-1195
- Research Site
-
Sendai-shi, Japan, 980-8574
- Research Site
-
Shinjuku-ku, Japan, 160-8582
- Research Site
-
Tsukuba, Japan, 305-8577
- Research Site
-
-
-
-
-
Jeju-si, Korea, Republic of, 690-767
- Research Site
-
Seoul, Korea, Republic of, 06591
- Research Site
-
Seoul, Korea, Republic of, 05030
- Research Site
-
Seoul, Korea, Republic of, 133792
- Research Site
-
Suwon-si, Korea, Republic of, 16499
- Research Site
-
-
-
-
-
Kaunas, Lithuania, LT-50009
- Research Site
-
Klaipeda, Lithuania, LT-92288
- Research Site
-
-
-
-
-
Chihuahua, Mexico, 31000
- Research Site
-
Leon, Mexico, 37000
- Research Site
-
Mexico, Mexico, 06700
- Research Site
-
Mexico D.F., Mexico, 014080
- Research Site
-
Morelia, Mexico, 58070
- Research Site
-
Mérida, Mexico, 97000
- Research Site
-
San Luis Potosí, Mexico, 78213
- Research Site
-
-
-
-
-
Kemerovo, Russian Federation, 650066
- Research Site
-
Petrozavodsk, Russian Federation, 185019
- Research Site
-
Smolensk, Russian Federation, 214015
- Research Site
-
Tolyatti, Russian Federation, 445039
- Research Site
-
Vladimir, Russian Federation, 600023
- Research Site
-
Yaroslavl, Russian Federation, 150003
- Research Site
-
-
-
-
-
Cape Town, South Africa, 7500
- Research Site
-
Johannesburg, South Africa, 2193
- Research Site
-
Johannesburg, South Africa, 2188
- Research Site
-
Stellenbosch, South Africa, 7600
- Research Site
-
-
-
-
-
Barcelona, Spain, 08035
- Research Site
-
Getafe, Spain, 28905
- Research Site
-
Las Palmas de Gran Canaria, Spain, 35010
- Research Site
-
Madrid, Spain, 28046
- Research Site
-
Madrid, Spain, 28702
- Research Site
-
Mérida, Spain, 06800
- Research Site
-
Santiago de Compostela, Spain, 15706
- Research Site
-
Servilla, Spain, 41014
- Research Site
-
Vigo, Spain, 36200
- Research Site
-
-
-
-
California
-
Covina, California, United States, 91723
- Research Site
-
Hemet, California, United States, 92543-4403
- Research Site
-
Los Angeles, California, United States, 90095
- Research Site
-
San Leandro, California, United States, 94578
- Research Site
-
Torrance, California, United States, 90509
- Research Site
-
Upland, California, United States, 91786
- Research Site
-
-
Colorado
-
Denver, Colorado, United States, 80230
- Research Site
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06606
- Research Site
-
Bridgeport, Connecticut, United States, 6606
- Research Site
-
-
Florida
-
Brandon, Florida, United States, 33511
- Research Site
-
Orlando, Florida, United States, 32804
- Research Site
-
Palm Harbor, Florida, United States, 34684
- Research Site
-
Tamarac, Florida, United States, 33321
- Research Site
-
Tampa, Florida, United States, 33614
- Research Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Research Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Research Site
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Research Site
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68516
- Research Site
-
-
New Mexico
-
Las Cruces, New Mexico, United States, 88011
- Research Site
-
-
New York
-
Brooklyn, New York, United States, 11201
- Research Site
-
New York, New York, United States, 10016
- Research Site
-
New York, New York, United States, 10021
- Research Site
-
New York, New York, United States, 10032
- Research Site
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- Research Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Research Site
-
-
Pennsylvania
-
Duncansville, Pennsylvania, United States, 16635
- Research Site
-
Pittsburgh, Pennsylvania, United States, 15213
- Research Site
-
-
Tennessee
-
Memphis, Tennessee, United States, 38163
- Research Site
-
-
Texas
-
Dallas, Texas, United States, 75231
- Research Site
-
Houston, Texas, United States, 77034
- Research Site
-
Houston, Texas, United States, 77004
- Research Site
-
Stafford, Texas, United States, 77477
- Research Site
-
-
Virginia
-
Arlington, Virginia, United States, 22205
- Research Site
-
-
Washington
-
Seattle, Washington, United States, 98122
- Research Site
-
Spokane, Washington, United States, 99204
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 through 70 years at the time of screening
- Diagnosis of paediatric or adult SLE with a diagnosis of SLE according to the ACR 1982 revised criteria ≥24 weeks prior to signing the Informed Consent form (ICF)
Currently receiving at least 1 of the following:
- Where prednisone is the single standard of care medication (ie, the subject is not concurrently receiving any medication listed in inclusion criterion 3(c)), a dose of oral prednisone ≥7.5 mg/day but ≤40 mg/day (or prednisone equivalent) for a minimum of 8 weeks prior to Day 1. In addition, the dose of oral prednisone or prednisone equivalent the subject is taking must be stable for a minimum of 2 weeks prior to randomisation
- Where prednisone is not the single standard of care medication (ie, the subject is concurrently receiving at least one medication listed in inclusion criterion 3(c), a dose of oral prednisone (≤40 mg/day) (or prednisone equivalent) for a minimum of 2 weeks prior to signing of the ICF. In addition, the dose of oral prednisone or prednisone equivalent the subject is taking must be stable for a minimum of 2 weeks prior to randomisation.
- Any of the following medications administered for a minimum of 12 weeks prior to signing the informed consent, and at a stable dose for a minimum of 8 weeks prior to signing the informed consent and through Day 1:
(i) Azathioprine ≤200 mg/day (ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day
Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for SLE, at least 1 of which must be:
- Positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at the central laboratory with titre ≥1:80; OR
- Anti-dsDNA antibodies at screening elevated to above normal (including indeterminate), as per the central laboratory; OR
- Anti-Smith (anti-Sm) antibody at screening elevated to above normal as per the central laboratory
At Screening, Disease Activity Adjudication Group confirmation of:
SLEDAI-2K Criteria: SLEDAI-2K score ≥6 points and "Clinical" SLEDAI-2K score ≥4 points. The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures.
- Must not have active or latent TB on either chest radiograph or by quantiferon gold test
- Day 1 "Clinical" SLEDAI-2K score ≥4 points
- OCS dose stable for at least 2 weeks prior to randomisation
- Stable SLE SOC treatment at the time of randomisation
- Women of child-bearing potential must have a negative serum β-hCG test at and negative urine pregnancy test at randomisation prior to administration of investigational product
Exclusion Criteria:
- Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater
Receipt of any of the following:
(a) Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks prior to Day 1
- History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome.
- Active severe or unstable neuropsychiatric SLE
- Active severe SLE-driven renal disease
- Diagnosis (within 1 year of signing the ICF) of mixed connective tissue disease or any history of overlap syndromes of SLE or SSc.
- History of, or current, inflammatory joint or skin disease other than SLE
- History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the last 24 weeks prior to signing the ICF
- 26.27. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation
- Confirmed positive test for hepatitis B or hepatitis C
- Any severe herpes infection at any time prior to Week 0 (Day 1)
- Opportunistic infection requiring hospitalisation or intravenous antimicrobial treatment within 3 years prior to randomization
History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin that has been successfully treated
- Cervical cancer in situ that has been successfully treated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anifrolumab
Anifrolumab 300 mg intravenous infusion (IV) administered every 4 weeks for a total of 13 doses.
|
Intravenous infusion (IV)
|
Placebo Comparator: Placebo
Placebo intravenous infusion (IV) administered every 4 weeks for a total of 13 doses.
|
Intravenous infusion (IV)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52
Time Frame: Baseline; Week 52
|
Composite endpoint BICLA was defined by meeting all of the following criteria:
|
Baseline; Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group
Time Frame: Baseline; Week 52
|
Defined by meeting all of the following criteria:
|
Baseline; Week 52
|
Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day
Time Frame: Week 40; Week 52
|
Maintained OCS reduction was defined by meeting all of the following criteria:
|
Week 40; Week 52
|
Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10
Time Frame: Baseline; Week 12
|
50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria:
|
Baseline; Week 12
|
Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline
Time Frame: Baseline; Week 52
|
50% reduction in the number of swollen and tender joints compared to baseline was defined by meeting all of the following criteria:
|
Baseline; Week 52
|
Annualised Flare Rate Through 52 Weeks
Time Frame: Baseline to Week 52
|
A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit.
The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52.
If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13.
The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year).
The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.
|
Baseline to Week 52
|
Number of Participants With One or More Adverse Events (AEs)
Time Frame: Baseline to end of study (Maximum of 60 weeks)
|
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
The reported value is inclusive of serious and non-serious AEs.
|
Baseline to end of study (Maximum of 60 weeks)
|
Number of Participants With One or More Adverse Events of Special Interest (AESIs)
Time Frame: Baseline to end of study (Maximum of 60 weeks)
|
An AESI is an adverse event (AE) of scientific and medical concern specific to understanding biologics. An AESI may be serious or non-serious. AESI are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, tuberculosis (TB) (including latent TB), influenza, vasculitis (non-systemic lupus erythematosus [SLE]), and major adverse cardiovascular events (MACE) (including stroke, myocardial infarction [MI], or cardiovascular death). AESIs were collected throughout the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). |
Baseline to end of study (Maximum of 60 weeks)
|
Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements
Time Frame: Baseline to end of study (Maximum of 60 weeks)
|
Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). |
Baseline to end of study (Maximum of 60 weeks)
|
Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests
Time Frame: Baseline to end of study (Maximum of 60 weeks)
|
Clinical laboratory tests were analyzed in a central clinical laboratory and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). |
Baseline to end of study (Maximum of 60 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lilia Pineda, MD, Medical Science Director
Publications and helpful links
General Publications
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Bruce IN, van Vollenhoven RF, Morand EF, Furie RA, Manzi S, White WB, Abreu G, Tummala R. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post-hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology (Oxford). 2022 Aug 26:keac491. doi: 10.1093/rheumatology/keac491. Online ahead of print.
- Bruce IN, Furie RA, Morand EF, Manzi S, Tanaka Y, Kalunian KC, Merrill JT, Puzio P, Maho E, Kleoudis C, Albulescu M, Hultquist M, Tummala R. Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials. Ann Rheum Dis. 2022 Jul;81(7):962-969. doi: 10.1136/annrheumdis-2021-221847. Epub 2022 May 17.
- Vital EM, Merrill JT, Morand EF, Furie RA, Bruce IN, Tanaka Y, Manzi S, Kalunian KC, Kalyani RN, Streicher K, Abreu G, Tummala R. Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials. Ann Rheum Dis. 2022 Jul;81(7):951-961. doi: 10.1136/annrheumdis-2021-221425. Epub 2022 Mar 25.
- Loncharich MF, Anderson CW. Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. ACR Open Rheumatol. 2022 Jun;4(6):486-491. doi: 10.1002/acr2.11414. Epub 2022 Feb 14.
- Chia YL, Zhang J, Tummala R, Rouse T, Furie RA, Morand EF. Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 May 5;61(5):1900-1910. doi: 10.1093/rheumatology/keab704.
- Furie R, Morand EF, Askanase AD, Vital EM, Merrill JT, Kalyani RN, Abreu G, Pineda L, Tummala R. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. doi: 10.1177/09612033211014267. Epub 2021 May 12.
- Furie R, Morand EF, Bruce IN, Isenberg D, van Vollenhoven R, Abreu G, Pineda L, Tummala R. What Does It Mean to Be a British Isles Lupus Assessment Group-Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials. Arthritis Rheumatol. 2021 Nov;73(11):2059-2068. doi: 10.1002/art.41778. Epub 2021 Sep 22.
- Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3461C00004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Active Systemic Lupus Erythematosus
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, France, Germany, Spain, Russian Federation, Peru, Taiwan, United Kingdom, Japan, Korea, Republic of, Argentina, Israel, Hungary, Bulgaria, Romania, Australia, Ukraine, Mexico, Canada, South Africa, Poland, Lithuania, ... and more
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, Italy, Korea, Republic of, Peru, Taiwan, New Zealand, Germany, Israel, Hungary, Australia, Poland, United Kingdom, Romania, Ukraine, Brazil, Argentina, Chile, Colombia
-
AmgenTerminatedActive Systemic Lupus ErythematosusKorea, Republic of, United States, Taiwan, Canada, Spain, Italy, Mexico, Japan, Turkey, Austria, Greece, Colombia, Switzerland, Poland, France, Bulgaria, Hong Kong, Russian Federation, Chile
-
AstraZenecaActive, not recruitingActive Systemic Lupus ErythematosusThailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
-
Nantes University HospitalTerminatedSerologically Active Adult Systemic Lupus ErythematosusFrance
-
BiogenCompletedSystemic Lupus Erythematosus | Active Cutaneous Lupus ErythematosusUnited States, Taiwan, Philippines, Argentina, Poland, Israel, Bulgaria, Serbia, Mexico, Colombia, Korea, Republic of, Thailand
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
Kyowa Kirin Co., Ltd.RecruitingHealthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)Japan
-
Second Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaboratorsActive, not recruitingCutaneous Lupus Erythematosus | Systemic Lupus Erythematosus RashChina
-
University Hospital, BrestRecruitingSystemic Lupus Erythematosus (SLE)France
Clinical Trials on Anifrolumab
-
AstraZenecaCompleted
-
AstraZenecaCompletedA Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy SubjectsHealthy Subjects | Pharmacokinetics | SafetyUnited States
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, France, Germany, Spain, Russian Federation, Peru, Taiwan, United Kingdom, Japan, Korea, Republic of, Argentina, Israel, Hungary, Bulgaria, Romania, Australia, Ukraine, Mexico, Canada, South Africa, Poland, Lithuania, ... and more
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, Italy, Korea, Republic of, Peru, Taiwan, New Zealand, Germany, Israel, Hungary, Australia, Poland, United Kingdom, Romania, Ukraine, Brazil, Argentina, Chile, Colombia
-
AstraZenecaParexelCompletedLupus NephritisUnited States, Italy, Spain, Taiwan, Peru, Belgium, France, Korea, Republic of, Mexico, Germany, Australia, Hungary, Serbia, Russian Federation, United Kingdom, Poland, Argentina
-
Josef Smolen, Univ. Prof. Dr.Unknown
-
AstraZenecaActive, not recruitingActive Systemic Lupus ErythematosusThailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
-
MedImmune LLCCompletedLupus Erythematosus, SystemicUnited States, Korea, Republic of, Mexico, Peru, Hungary, Ukraine, Czechia, Bulgaria, Colombia, Brazil, Poland, Romania, Taiwan
-
AstraZenecaClinigen, Inc.No longer availableSystemic Lupus Erythematosus
-
University Hospital, BordeauxAstraZenecaRecruiting