Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: Medi-546

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 Type: Interventional
• Enrollment (Actual): 367
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad de Buenos Aires, Argentina, C1431FWO
    • Research Site
  • La Plata, Argentina, 1900
    • Research Site
  • Mendoza, Argentina, 5500
    • Research Site
  • Pergamino, Argentina, B2700CPM
    • Research Site
  • Quilmes, Argentina, B1878GEG
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  • Rosario, Argentina, S2000PBJ
    • Research Site
  • Salta, Argentina, A4400ANW
    • Research Site
  • San Isidro, Argentina, 1643
    • Research Site
  • San Juan, Argentina, 5400
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  • San Miguel de Tucumán, Argentina, 4000
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  • San Miguel de Tucumán, Argentina, T4000AXL
    • Research Site
  • San Miguel de Tucumán, Argentina, T4000ICL
    • Research Site
• Bulgaria
  • Kardzhali, Bulgaria, 6600
    • Research Site
  • Pleven, Bulgaria, 5800
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  • Plovdiv, Bulgaria, 4003
    • Research Site
  • Sevlievo, Bulgaria, 5400
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  • Sofia, Bulgaria, 1431
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  • Sofia, Bulgaria, 1784
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  • Sofia, Bulgaria, 1407
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  • Sofia, Bulgaria, 1606
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  • Sofia, Bulgaria, 1797
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• Chile
  • Osorno, Chile, 5290000
    • Research Site
  • Santiago, Chile, 8320000
    • Research Site
  • Santiago, Chile, 7500710
    • Research Site
  • Santiago, Chile, 7501126
    • Research Site
  • Santiago, Chile, 7500010
    • Research Site
  • Santiago, Chile, 7500588
    • Research Site
  • Santiago, Chile, 7500571
    • Research Site
  • Valdivia, Chile, 5090000
    • Research Site
• Colombia
  • Barranquilla, Colombia, 080020
    • Research Site
  • Barranquilla, Colombia, 080002
    • Research Site
  • Bogotá, Colombia, 110221
    • Research Site
  • Bucaramanga, Colombia, 680003
    • Research Site
  • Chía, Colombia, 250001
    • Research Site
  • Montería, Colombia, 230002
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Research Site
  • Cologne, Germany, 50937
    • Research Site
  • Leipzig, Germany, 04103
    • Research Site
  • Tübingen, Germany, 72076
    • Research Site
• Hungary
  • Budapest, Hungary, 1027
    • Research Site
  • Budapest, Hungary, 1097
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  • Gyula, Hungary, 5700
    • Research Site
  • Székesfehérvár, Hungary, 8000
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  • Veszprém, Hungary, 8200
    • Research Site
• Japan
  • Chiba, Japan, 260-8712
    • Research Site
  • Chūōku, Japan, 104-8560
    • Research Site
  • Hamamatsu, Japan, 431-3192
    • Research Site
  • Hiroshima, Japan, 734-8551
    • Research Site
  • Itabashi-ku, Japan, 173-8610
    • Research Site
  • Kita-gun, Japan, 761-0793
    • Research Site
  • Kitakyushu-shi, Japan, 807-8555
    • Research Site
  • Meguro-ku, Japan, 152-8902
    • Research Site
  • Meguro-ku, Japan, 153-8515
    • Research Site
  • Nagasaki, Japan, 852-8501
    • Research Site
  • Nagoya, Japan, 460-0001
    • Research Site
  • Nagoya, Japan, 457-8510
    • Research Site
  • Okayama, Japan, 700-8607
    • Research Site
  • Sagamihara-shi, Japan, 252-0375
    • Research Site
  • Sasebo-shi, Japan, 857-1195
    • Research Site
  • Sendai, Japan, 980-8574
    • Research Site
  • Shinjuku-ku, Japan, 160-8582
    • Research Site
• Mexico
  • Chihuahua City, Mexico, 31000
    • Research Site
  • Culiacán, Mexico, 80000
    • Research Site
  • Durango, Mexico, 43080
    • Research Site
  • Guadalajara, Mexico, 44130
    • Research Site
  • Guadalajara, Mexico, 44650
    • Research Site
  • Guadalajara, Mexico, 44950
    • Research Site
  • Mexicali, Mexico, 21200
    • Research Site
  • Mérida, Mexico, 97070
    • Research Site
  • Mérida, Mexico, 97000
    • Research Site
  • México, Mexico, 03100
    • Research Site
  • México, Mexico, 03720
    • Research Site
  • México, Mexico, 06700
    • Research Site
• Philippines
  • Quezon City, Philippines, 1118
    • Research Site
• Poland
  • Katowice, Poland, 40-081
    • Research Site
  • Kościan, Poland, 64-000
    • Research Site
  • Krakow, Poland, 30-510
    • Research Site
  • Krakow, Poland, 30-033
    • Research Site
  • Krakow, Poland, 30-363
    • Research Site
  • Lodz, Poland, 90-368
    • Research Site
  • Lublin, Poland, 20-607
    • Research Site
  • Nowa Sól, Poland, 67-100
    • Research Site
  • Ustroń, Poland, 43-450
    • Research Site
  • Warsaw, Poland, 00-874
    • Research Site
  • Warsaw, Poland, 02-118
    • Research Site
  • Warsaw, Poland, 02-691
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  • Wroclaw, Poland, 50-088
    • Research Site
  • Wroclaw, Poland, 50-244
    • Research Site
• Spain
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 8035
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Madrid, Spain, 28702
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Seville, Spain, 41010
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
• Thailand
  • Muang, Thailand, 50200
    • Research Site
  • Rachathewi, Thailand, 10400
    • Research Site
• Ukraine
  • Kyiv, Ukraine, 01601
    • Research Site
  • Kyiv, Ukraine, 04050
    • Research Site
  • Kyiv, Ukraine, 02091
    • Research Site
  • Odesa, Ukraine, 65025
    • Research Site
  • Vinnytsia, Ukraine, 21029
    • Research Site
  • Vinnytsia, Ukraine, 21001
    • Research Site
  • Zaporizhzhia, Ukraine, 69600
    • Research Site
• United Kingdom
  • Doncaster, United Kingdom, DN2 5LT
    • Research Site
  • Leeds, United Kingdom, LS7 4SA
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Research Site
  • Arizona
    • Paradise Valley, Arizona, United States, 85253
      • Research Site
    • Phoenix, Arizona, United States, 85032
      • Research Site
  • California
    • El Cajon, California, United States, 92020
      • Research Site
    • Fullerton, California, United States, 92835
      • Research Site
    • Hemet, California, United States, 92543
      • Research Site
    • La Mesa, California, United States, 91942
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Menifee, California, United States, 92586
      • Research Site
    • Upland, California, United States, 91786
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
  • Florida
    • Brandon, Florida, United States, 33511
      • Research Site
    • Clearwater, Florida, United States, 33765
      • Research Site
    • Clearwater, Florida, United States, 33759
      • Research Site
    • Miami, Florida, United States, 33180
      • Research Site
    • Tampa, Florida, United States, 33613
      • Research Site
    • Tampa, Florida, United States, 33614
      • Research Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Research Site
  • Michigan
    • Flint, Michigan, United States, 48504
      • Research Site
    • Lansing, Michigan, United States, 48911
      • Research Site
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Research Site
  • New Mexico
    • Las Cruces, New Mexico, United States, 88011
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11201
      • Research Site
    • Manhasset, New York, United States, 11030
      • Research Site
    • New York, New York, United States, 10032
      • Research Site
    • Potsdam, New York, United States, 13676
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Charlotte, North Carolina, United States, 28203
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Research Site
    • Reading, Pennsylvania, United States, 19610
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Site
  • Texas
    • Grapevine, Texas, United States, 76051
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening

3. BILAG2004 with at least 1 of the following:

   1. BILAG2004 level A disease in ≥ 1 organ system
   2. BILAG2004 level B disease in ≥ 2 organ systems
4. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,

6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

   Exclusion Criteria:

7. Active severe or unstable neuropsychiatric SLE
8. Active severe SLE-driven renal disease
9. 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.
10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
11. 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.
12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.

15. History of cancer, apart from:

    1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
    2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anifrolumab; 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.
Placebo Comparator: Placebo; Solution for injection in aPFS	Drug: Placebo; Solution for injection in aPFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first BICLA response sustained through Week 52	Time from first dose to first BICLA response that is consecutively maintained through Week 52	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.	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	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	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	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.	At week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Overview	Overview of AEs, SAEs and AESIs	Up to 2 years 4 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: IQVIA Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): August 22, 2025
• Study Completion (Estimated): November 6, 2026

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Substandard Drugs; Pharmaceutical Preparations; anifrolumab
• Other Study ID Numbers: D3465C00001; SZA64400; 2020-004529-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No