Active Systemic Lupus ErythematosusPhase 3TULIP SLE LTENCT02794285
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
A Phase 3 study testing Anifrolumab in people with Active Systemic Lupus Erythematosus, run by AstraZeneca at 175 sites in 24 countries.
Trial summary
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 559 participants
- Where
- 175 sitesin 24 countries
- Study dates
- 30 Jun 2016to 21 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
- Adequate peripheral venous access
- Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
- Meets the following TB criteria:
- Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR
- Newly positive QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must start on prophylaxis within 30 days of randomisation but prior to the second dose of investigational product (Visit 2/Week 4); OR
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- Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005. The subject must have been diagnosed with latent TB and must have documentation confirming initiation of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)
- Newly indeterminate (confirmed on retest unless prior positive QFT G was documented, along with completed treatment for latent TB) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan
- In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
Who cannot join
- Receipt of any of the following within the last 60 days:
- Azathioprine >200 mg/day
- Mycophenolate mofetil >2.0 g/day /mycophenolic acid >1.44 g/day
- Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
- Mizoribine >150 mg/day
- Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
Show all 13Show fewer
- Receipt of any of the following:
- Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry)
- Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1
- Active severe SLE-driven renal or neuropsychiatric disease
- Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
- Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
- Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
Trial locations and contacts
175 sites in 24 countries.
175 sites in 24 countries
United States62 sites
Research Site
Amarillo, Texas, 79124
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80045
Research Site
Austin, Texas, 78726
Research Site
Austin, Texas, 78745
Research Site
Birmingham, Alabama, 35294-3280
Research Site
Boise, Idaho, 83702
Research Site
Brandon, Florida, 33511
Research Site
Bridgeport, Connecticut, 06606
Research Site
Brooklyn, New York, 11201
Research Site
Charlotte, North Carolina, 28210
Research Site
Charlotte, North Carolina, 28277
Research Site
Cumberland, Maryland, 21502
Research Site
Dallas, Texas, 75231
Research Site
DeBary, Florida, 32713
Research Site
Decatur, Georgia, 30033
Research Site
Denver, Colorado, 80230
Research Site
El Cajon, California, 92020
Research Site
Freehold, New Jersey, 07728
Research Site
Grand Rapids, Michigan, 49546
Research Site
Great Neck, New York, 11021
Research Site
Greenville, North Carolina, 27834
Research Site
Hagerstown, Maryland, 21740
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Hemet, California, 92543
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Houston, Texas, 77004
Research Site
Houston, Texas, 77034
Research Site
Houston, Texas, 77074
Research Site
Idaho Falls, Idaho, 83404
Research Site
La Jolla, California, 92037
Research Site
Las Cruces, New Mexico, 88011
Research Site
Lawrenceville, Georgia, 30046
Research Site
Los Alamitos, California, 90720
Research Site
Los Angeles, California, 90024
Research Site
Marietta, Georgia, 30060
Research Site
Memphis, Tennessee, 38104
Research Site
Memphis, Tennessee, 38119
Research Site
Mesquite, Texas, 75150
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Miami, Florida, 33136
Research Site
Miami, Florida, 33180
Research Site
Middleburg Heights, Ohio, 44130
Research Site
Milwaukee, Wisconsin, 53217
Research Site
Minneapolis, Minnesota, 55455-0341
Research Site
Nashua, New Hampshire, 03060
Research Site
New Hyde Park, New York, 11042
Research Site
New York, New York, 10016
Research Site
New York, New York, 10021
Research Site
New York, New York, 10032
Research Site
North Charleston, South Carolina, 29406
Research Site
Oklahoma City, Oklahoma, 73102
Research Site
Oklahoma City, Oklahoma, 73104
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Ormond Beach, Florida, 32174
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Philadelphia, Pennsylvania, 19140
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Pittsburgh, Pennsylvania, 15213
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Raleigh, North Carolina, 27617
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Reading, Pennsylvania, 19610
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San Leandro, California, 94578
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Spokane, Washington, 99204
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Stafford, Texas, 77477
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Tampa, Florida, 33614
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Thousand Oaks, California, 91360
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Upland, California, 91786
Research Site
Vero Beach, Florida, 32960
Japan15 sites
Research Site
Chiba, 260-8712
Research Site
Chūōku, 104-8560
Research Site
Fukuoka, 810-0065
Research Site
Fukuoka, 810-8539
Research Site
Hiroshima, 730-8619
Research Site
Kitakyushu-shi, 807-8556
Research Site
Kurashiki-shi, 710-8522
Research Site
Meguro-ku, 152-8902
Research Site
Meguro-ku, 153-8515
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Nagasaki, 852-8501
Research Site
Omura-shi, 856-8562
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Sapporo, 060-8648
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Sasebo-shi, 857-1195
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Sendai, 980-8574
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Shinjuku-ku, 160-8582
Poland10 sites
Research Site
Bialystok, 15-297
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Bydgoszcz, 85 168
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Kościan, 64-000
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Krakow, 31-011
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Lublin, 20-607
Research Site
Nadarzyn, 05-830
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Starachowice, 27-200
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Szczecin, 71-252
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Ustroń, 43-450
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Warsaw, 02-118
South Korea7 sites
Research Site
Daejeon, 35015
Research Site
Gwangju, 61469
Research Site
Jeju City, 690-767
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Seoul, 05030
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Seoul, 06591
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Seoul, 07345
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Suwon, 16499
Ukraine7 sites
Research Site
Kyiv, 01601
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Kyiv, 03680
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Lviv, 79011
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Ternopil, 46001
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Uzhhorod, 88018
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Vinnytsia, 21018
Research Site
Zaporizhzhya, 69600
France6 sites
Research Site
Bordeaux, 33076
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Lille, 59037
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Montpellier, 34295
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Paris, 75014
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Paris, 75651
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Pessac, 33604
Germany6 sites
Research Site
Berlin, 10117
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Frankfurt am Main, 60528
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Hamburg, 20246
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Jena, 07747
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Kirchheim, 73230
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Mainz Am Rhein, 55131
Mexico6 sites
Research Site
Chihuahua City, 31000
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León, 37000
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Mérida, 97000
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México, 06700
Research Site
Mexico City, 014080
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San Luis Potosí City, 78213
Peru6 sites
Research Site
Arequipa, 04000
Research Site
Lima, 15023
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Lima, 15033
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Lima, 15046
Research Site
Lima, 15073
Research Site
Lima, 15102
Israel5 sites
Research Site
Haifa, 31048
Research Site
Haifa, 31096
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Jerusalem, 91120
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Kfar Saba, 49281
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Tel Aviv, 64239
Romania5 sites
Research Site
Brasov, 500283
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Bucharest, 011172
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Cluj-Napoca, 400006
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Galati, 800578
Research Site
Târgu Mureş, 540136
Spain5 sites
Research Site
Barcelona, 08035
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Getafe, 28905
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Mérida, 06800
Research Site
Servilla, 41014
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Vigo, 36200
Hungary4 sites
Research Site
Budapest, 1097
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Debrecen, 4032
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Szeged, 6725
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Zalaegerszeg, 8900
Russia4 sites
Research Site
Smolensk, 214015
Research Site
Tolyatti, 445039
Research Site
Vladimir, 600023
Research Site
Yaroslavl, 150003
United Kingdom4 sites
Research Site
Doncaster, DN2 5LT
Research Site
Leeds, LS7 4SA
Research Site
London, SE1 9RT
Research Site
Manchester, M13 9WL
Argentina3 sites
Research Site
Mendoza, 5500
Research Site
Quilmes, 1878
Research Site
San Miguel de Tucumán, T4000AXL
Chile3 sites
Research Site
Osorno, 5311092
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Santiago, 8320000
Research Site
Viña del Mar, 2520997
Colombia3 sites
Research Site
Armenia, 630004
Research Site
Barranquilla, 080002
Research Site
Medellín, 050021
South Africa3 sites
Research Site
Cape Town, 7500
Research Site
Johannesburg, 2021
Research Site
Stellenbosch, 7600
Taiwan3 sites
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40705
Research Site
Taipei, 10002
Canada2 sites
Research Site
Hamilton, Ontario, L8S 4K1
Research Site
Rimouski, Quebec, G5L 5T1
Lithuania2 sites
Research Site
Kaunas, LT-50009
Research Site
Klaipėda, LT-92288
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
Read the detailed description
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period.
- Conditions
- Active Systemic Lupus Erythematosus
- Being tested
- Anifrolumab, Placebo
- Keywords
- Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases
- Medical subject headings
- Connective Tissue Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabBiological
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
PlaceboDrug
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | Anifrolumab Receives: Biological: Anifrolumab |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs)
The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years.
The following AESIs were pre-defined:
- Non-opportunistic serious infections
- Opportunistic infections
- Anaphylaxis
- Malignancy
- Herpes zoster
- Tuberculosis (TB) (including latent TB)
- Influenza
- Vasculitis (non-systemic lupus erythematosus [SLE])
- Major cardiovascular events as according to the Cardiovascular Event Adjudication Committee.
Measured: Up to a maximum of 1114 days
EAIRs of Serious Adverse Events (SAEs)
EAIRs of SAEs are presented as event rate per 100 participant years.
An SAE was an AE occurring during any study phase that fulfils 1 or more of the following criteria:
- Results in death
- Is immediately life-threatening
- Requires in-patient hospitalisation or prolongation of existing hospitalisation
- Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions
- Is a congenital abnormality or birth defect
- Is an important medical event that may jeopardise the participant or may require medical intervention to prevent one of the outcomes listed above.
Measured: Up to a maximum of 1114 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start30 Jun 2016
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Active Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Kenneth Kalunian, MD, Principal investigator, University of California, San DiegoRaj Tummala, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794285
- Sponsor's protocol ID
- D3461C00009
- Acronym
- TULIP SLE LTE
- Status last verified
- Dec 2022
- First submitted
- 6 Jun 2016
- Last updated
- 13 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Strand V, Kalunian KC, Lee KW, Seo C, Abreu G, Tummala R, Al-Mossawi H, Duncan EA, Lindholm C. Long-term effect of anifrolumab on patient-reported outcomes in systemic lupus erythematosus (TULIP-LTE): a randomised, placebo-controlled, phase 3 long-term extension trial. Lancet Rheumatol. 2025 Jul;7(7):e485-e494. doi: 10.1016/S2665-9913(25)00022-0. Epub 2025 May 2.
PubMed 40324450Tanaka Y, Atsumi T, Okada M, Miyamura T, Ishii T, Nishiyama S, Matsumura R, Kawakami A, Hayashi N, Abreu G, Yavuz S, Lindholm C, Al-Mossawi H, Takeuchi T. The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis. Mod Rheumatol. 2024 Jul 6;34(4):720-731. doi: 10.1093/mr/road092.
PubMed 37706527Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11.
PubMed 36369793
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
- ClinicalTrials.gov ID
- NCT02794285
- Acronym / sponsor ID
- TULIP SLE LTE / D3461C00009
- Conditions
- Active Systemic Lupus Erythematosus
- Keywords
- Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 13 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
Detailed description
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Experimental | Biological: AnifrolumabAnifrolumab |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
- Adequate peripheral venous access
- Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
- Meets the following TB criteria:
- In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
Key exclusion criteria (13 listed)
- Receipt of any of the following within the last 60 days:
- Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
- Receipt of any of the following:
- Active severe SLE-driven renal or neuropsychiatric disease
- Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnifrolumabAnifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses | Biological | Anifrolumab |
| PlaceboPlacebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses | Drug | Placebo |
Primary outcome
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs)
Time frame: Up to a maximum of 1114 days
The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years. The following AESIs were pre-defined: * Non-opportunistic serious infections * Opportunistic infections * Anaphylaxis * Malignancy * Herpes zoster * Tuberculosis (TB) (including latent TB) * Influenza * Vasculitis (non-systemic lupus erythematosus [SLE]) * Major cardiovascular events as according to the Cardiovascular Event Adjudication Committee.
EAIRs of Serious Adverse Events (SAEs)
Time frame: Up to a maximum of 1114 days
EAIRs of SAEs are presented as event rate per 100 participant years. An SAE was an AE occurring during any study phase that fulfils 1 or more of the following criteria: * Results in death * Is immediately life-threatening * Requires in-patient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * Is a congenital abnormality or birth defect * Is an important medical event that may jeopardise the participant or may require medical intervention to prevent one of the outcomes listed above.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40324450Strand V, Kalunian KC, Lee KW, Seo C, Abreu G, Tummala R, Al-Mossawi H, Duncan EA, Lindholm C. Long-term effect of anifrolumab on patient-reported outcomes in systemic lupus erythematosus (TULIP-LTE): a randomised, placebo-controlled, phase 3 long-term extension trial. Lancet Rheumatol. 2025 Jul;7(7):e485-e494. doi: 10.1016/S2665-9913(25)00022-0. Epub 2025 May 2.
- Derived from this study: PubMed 37706527Tanaka Y, Atsumi T, Okada M, Miyamura T, Ishii T, Nishiyama S, Matsumura R, Kawakami A, Hayashi N, Abreu G, Yavuz S, Lindholm C, Al-Mossawi H, Takeuchi T. The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis. Mod Rheumatol. 2024 Jul 6;34(4):720-731. doi: 10.1093/mr/road092.
- Derived from this study: PubMed 36369793Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Kalunian, MD principal investigator
University of California, San Diego
Raj Tummala, MD study director
AstraZeneca
175 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anifrolumab in people with Active Systemic Lupus Erythematosus, run by AstraZeneca at 175 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 175 sites in United States, Japan, Poland, South Korea, Ukraine and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs) (time frame: Up to a maximum of 1114 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794285, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.