Systemic Lupus ErythematosusPhase 3Tulip SCNCT04877691
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
A Phase 3 study testing Medi-546 in people with Systemic Lupus Erythematosus, run by AstraZeneca at 140 sites in 15 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Medi-546
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 140 sitesin 15 countries
- Study dates
- 8 Jun 2021to 6 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
- To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
- BILAG2004 with at least 1 of the following:
- BILAG2004 level A disease in ≥ 1 organ system
- BILAG2004 level B disease in ≥ 2 organ systems
- Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
- Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
- Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.
Who cannot join
- Active severe or unstable neuropsychiatric SLE
- Active severe SLE-driven renal disease
- History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
- History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
- At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
Show all 11Show fewer
- Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
- Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
- History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
- Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).
Trial locations and contacts
140 sites in 15 countries.
140 sites in 15 countries
United States33 sites
Research Site
Aurora, Colorado, 80045
Research Site
Birmingham, Alabama, 35233
Research Site
Brandon, Florida, 33511
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Brooklyn, New York, 11201
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Charlotte, North Carolina, 28203
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Charlotte, North Carolina, 28204
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Clearwater, Florida, 33759
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Clearwater, Florida, 33765
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El Cajon, California, 92020
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Flint, Michigan, 48504
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Fullerton, California, 92835
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Grapevine, Texas, 76051
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Hemet, California, 92543
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Idaho Falls, Idaho, 83404
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La Mesa, California, 91942
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Lansing, Michigan, 48911
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Las Cruces, New Mexico, 88011
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Los Angeles, California, 90095
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Manhasset, New York, 11030
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Memphis, Tennessee, 38119
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Menifee, California, 92586
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Miami, Florida, 33180
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New York, New York, 10032
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Newark, New Jersey, 07103
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Oklahoma City, Oklahoma, 73104
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Paradise Valley, Arizona, 85253
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Phoenix, Arizona, 85032
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Pittsburgh, Pennsylvania, 15224
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Potsdam, New York, 13676
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Reading, Pennsylvania, 19610
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Tampa, Florida, 33613
Research Site
Tampa, Florida, 33614
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Upland, California, 91786
Japan17 sites
Research Site
Chiba, 260-8712
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Chūōku, 104-8560
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Hamamatsu, 431-3192
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Hiroshima, 734-8551
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Kita-gun, 761-0793
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Kitakyushu-shi, 807-8555
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Meguro-ku, 152-8902
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Meguro-ku, 153-8515
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Nagasaki, 852-8501
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Nagoya, 457-8510
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Nagoya, 460-0001
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Okayama, 700-8607
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Sagamihara-shi, 252-0375
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Sasebo-shi, 857-1195
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Sendai, 980-8574
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Shinjuku-ku, 160-8582
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tabashi City, 173-8610
Poland14 sites
Research Site
Katowice, 40-081
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Kościan, 64-000
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Krakow, 30-033
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Krakow, 30-363
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Krakow, 30-510
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Lodz, 90-368
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Lublin, 20-607
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Nowa Sól, 67-100
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Ustroń, 43-450
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Warsaw, 00-874
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Warsaw, 02-118
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Warsaw, 02-691
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Wroclaw, 50-088
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Wroclaw, 50-244
Argentina12 sites
Research Site
Ciudad de Buenos Aires, C1431FWO
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La Plata, 1900
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Mendoza, 5500
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Pergamino, B2700CPM
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Quilmes, B1878GEG
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Rosario, S2000PBJ
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Salta, A4400ANW
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San Isidro, 1643
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San Juan, 5400
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San Miguel de Tucumán, 4000
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San Miguel de Tucumán, T4000AXL
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San Miguel de Tucumán, T4000ICL
Mexico12 sites
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Chihuahua City, 31000
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Culiacán, 80000
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Durango, 43080
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Guadalajara, 44130
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Guadalajara, 44650
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Guadalajara, 44950
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Mérida, 97000
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Mérida, 97070
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Mexicali, 21200
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México, 03100
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México, 03720
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México, 06700
Bulgaria9 sites
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Kardzhali, 6600
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Pleven, 5800
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Plovdiv, 4003
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Sevlievo, 5400
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Sofia, 1407
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Sofia, 1431
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Sofia, 1606
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Sofia, 1784
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Sofia, 1797
Chile8 sites
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Osorno, 5290000
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Santiago, 7500010
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Santiago, 7500571
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Santiago, 7500588
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Santiago, 7500710
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Santiago, 7501126
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Santiago, 8320000
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Valdivia, 5090000
Spain7 sites
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Barcelona, 08036
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Barcelona, 8003
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Barcelona, 8035
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Madrid, 28702
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Santiago de Compostela, 15706
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Seville, 41010
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Valencia, 46026
Ukraine7 sites
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Kyiv, 01601
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Kyiv, 02091
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Kyiv, 04050
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Odesa, 65025
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Vinnytsia, 21001
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Vinnytsia, 21029
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Zaporizhzhya, 69600
Colombia6 sites
Research Site
Barranquilla, 080002
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Barranquilla, 080020
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Bogotá, 110221
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Bucaramanga, 680003
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Chía, 250001
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Montería, 230002
Hungary5 sites
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Budapest, 1027
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Budapest, 1097
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Gyula, 5700
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Székesfehérvár, 8000
Research Site
Veszprém, 8200
Germany4 sites
Research Site
Berlin, 10117
Research Site
Cologne, 50937
Research Site
Leipzig, 04103
Research Site
Tübingen, 72076
United Kingdom3 sites
Research Site
Doncaster, DN2 5LT
Research Site
Leeds, LS7 4SA
Research Site
London, SE1 9RT
About this study
Official title: A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
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
Read the detailed description
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).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Medi-546, Placebo
- Keywords
- Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medi-546Drug
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.
PlaceboDrug
Solution for injection in aPFS
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | Solution for injection in aPFS Receives: Drug: Medi-546 |
| Placebo | Placebo comparator | Solution for injection in aPFS Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria:
- Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D and no BILAG-2004 worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG 2004 B.
- No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of > 0 points in SLEDAI-2K.
- No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point PGA VAS.
Measured: At week 52
Secondary outcomes (6)
Time to first BICLA response sustained through Week 52
Time from first dose to first BICLA response that is consecutively maintained through Week 52
Measured: Baseline through to Week 52
BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)
Response is defined by being a BICLA responder at Week 52 and having maintained low (or reduced) OCS use through Week 52. Maintained OCS use is defined as follows:
- If baseline OCS ≥ 10 mg/day an OCS dose of ≤ 7.5 mg/day prednisone or equivalent must be achieved by Week 40 and an OCS dose ≤ 7.5 mg/day prednisone or equivalent must be maintained from Week 40 to Week 52.
- If baseline OCS < 10 mg/day, OCS dose at Week 40 must be less than or equal to OCS dose at baseline, with no increase from Week 40 OCS dose between Week 40 and Week 52.
Measured: At week 52
Time to flare
Flare defined as either 1 or more BILAG 2004 A or 2 or more BILAG 2004 B compared to previous visit
Measured: Baseline through to Week 52
Maintained oral corticosteroid (OCS) reduction among patients with baseline OCS ≥10 mg/day.
Achieving maintained OCS reduction through Week 52 is defined by meeting all of the following criteria:
- Achieve an OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Week 40
- Maintain an OCS dose ≤ 7.5 mg/day prednisone or equivalent from Week 40 to Week 52
- No discontinuation of investigational product
- No use of restricted medications beyond the protocol allowed threshold before assessment
Measured: At week 52
Annualized flare rate
Flare defined as either 1 or more BILAG 2004 or 2 or more BILAG2004 B compared to previous visit
Measured: Baseline through to Week 52
SRI4
Proportion of patients achieving a SRI of ≥ 4 (SRI[4]) response at Week 52, defined by meeting all of the following criteria:
Reduction from baseline of ≥ 4 points in the SLEDAI-2K No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG 2004 B items compared to baseline using BILAG-2004 No worsening from baseline in the patients' lupus disease activity, where worsening is defined by an increase ≥ 0.30 points on a 3-point PGA VAS.
Measured: At week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start8 Jun 2021
- Primary completion22 Aug 2025
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877691
- Sponsor's protocol ID
- D3465C00001
- Other IDs
- SZA64400, 2020-004529-22
- Acronym
- Tulip SC
- Status last verified
- Jul 2026
- First submitted
- 4 May 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04877691
- Acronym / sponsor ID
- Tulip SC / D3465C00001
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 367 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
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 evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Experimental | Drug: Medi-546Solution for injection in aPFS |
| Placebo | Placebo comparator | Drug: PlaceboSolution for injection in aPFS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
- To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
- BILAG2004 with at least 1 of the following:
- Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
- Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
Key exclusion criteria (11 listed)
- Active severe or unstable neuropsychiatric SLE
- Active severe SLE-driven renal disease
- History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
- History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
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 |
|---|---|---|
| Medi-546Patients 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 | Anifrolumab |
| PlaceboSolution for injection in aPFS | Drug | Placebo |
Primary outcome
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Time frame: At week 52
BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria: * Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D and no BILAG-2004 worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG 2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of > 0 points in SLEDAI-2K. * No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point PGA VAS.
6 secondary outcomes
Time to first BICLA response sustained through Week 52
Time frame: Baseline through to Week 52
BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)
Time frame: At week 52
Time to flare
Time frame: Baseline through to Week 52
Maintained oral corticosteroid (OCS) reduction among patients with baseline OCS ≥10 mg/day.
Time frame: At week 52
Annualized flare rate
Time frame: Baseline through to Week 52
SRI4
Time frame: At week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
The record lists no contact. Use the official record to reach the sponsor.
140 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medi-546 in people with Systemic Lupus Erythematosus, run by AstraZeneca at 140 sites in 15 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 140 sites in United States, Japan, Poland, Argentina, Mexico and 10 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?
This study is still under way. Results are not available in the source record yet.
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?
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response (time frame: At week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.