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

April 15, 2024 updated by: AstraZeneca

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

Recruiting

Conditions

Systemic Lupus Erythematosus

Intervention / Treatment

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 (Estimated)

360

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Ciudad de Buenos Aires, Argentina, C1431FWO
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5016KEH
    - Withdrawn
    - Research Site
  - La Plata, Argentina, 1900
    - Active, not recruiting
    - Research Site
  - Mendoza, Argentina, 5500
    - Recruiting
    - Research Site
  - Pergamino, Argentina, B2700CPM
    - Active, not recruiting
    - Research Site
  - Quilmes, Argentina, B1878GEG
    - Recruiting
    - Research Site
  - Rosario, Argentina, S2000PBJ
    - Recruiting
    - Research Site
  - Salta, Argentina, A4400ANW
    - Recruiting
    - Research Site
  - San Isidro, Argentina, 1643
    - Recruiting
    - Research Site
  - San Juan, Argentina, 5400
    - Recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, T4000AXL
    - Recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, T4000ICL
    - Recruiting
    - Research Site
Bulgaria
- - Kardzhali, Bulgaria, 6600
    - Recruiting
    - Research Site
  - Pleven, Bulgaria, 5800
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4003
    - Active, not recruiting
    - Research Site
  - Sevlievo, Bulgaria, 5400
    - Active, not recruiting
    - Research Site
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1431
    - Active, not recruiting
    - Research Site
  - Sofia, Bulgaria, 1797
    - Active, not recruiting
    - Research Site
  - Sofia, Bulgaria, 1606
    - Completed
    - Research Site
  - Sofia, Bulgaria, 1784
    - Active, not recruiting
    - Research Site
Chile
- - Osorno, Chile, 5290000
    - Completed
    - Research Site
  - Santiago, Chile, 7500010
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500571
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500710
    - Recruiting
    - Research Site
  - Santiago, Chile, 7501126
    - Recruiting
    - Research Site
  - Santiago, Chile, 8320000
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500588
    - Completed
    - Research Site
  - Valdivia, Chile, 5090000
    - Completed
    - Research Site
Colombia
- - Barranquilla, Colombia, 080020
    - Recruiting
    - Research Site
  - Barranquilla, Colombia, 080002
    - Recruiting
    - Research Site
  - Bogota, Colombia, 110221
    - Recruiting
    - Research Site
  - Bucaramanga, Colombia, 680003
    - Withdrawn
    - Research Site
  - Bucaramanga, Colombia, 680003
    - Recruiting
    - Research Site
  - Chia, Colombia, 250001
    - Recruiting
    - Research Site
  - Medellin, Colombia, 050034
    - Withdrawn
    - Research Site
  - Monteria, Colombia, 230002
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 10117
    - Recruiting
    - Research Site
  - Berlin, Germany, D-10117
    - Recruiting
    - Research Site
  - Dresden, Germany, 01067
    - Recruiting
    - Research Site
  - Kirchheim, Germany, 73230
    - Withdrawn
    - Research Site
  - Köln, Germany, 50937
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
  - Tuebingen, Germany, 72076
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1036
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1027
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1097
    - Recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Recruiting
    - Research Site
  - Szekesfehervar, Hungary, 8000
    - Recruiting
    - Research Site
  - Veszprem, Hungary, 8200
    - Completed
    - Research Site
Japan
- - Chiba-shi, Japan, 260-8712
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 104-8560
    - Recruiting
    - Research Site
  - Hamamatsu-shi, Japan, 430-0906
    - Recruiting
    - Research Site
  - Hamamatsu-shi, Japan, 431-3192
    - Recruiting
    - Research Site
  - Hiroshima-shi, Japan, 734-8551
    - Recruiting
    - Research Site
  - Itabashi-ku, Japan, 173-8610
    - Recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Recruiting
    - Research Site
  - Kitakyushu-shi, Japan, 807-8555
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 152-8902
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 153-8515
    - Recruiting
    - Research Site
  - Nagasaki-shi, Japan, 852-8501
    - Recruiting
    - Research Site
  - Nagoya, Japan, 457-8510
    - Recruiting
    - Research Site
  - Nagoya-shi, Japan, 460-0001
    - Recruiting
    - Research Site
  - Okayama-shi, Japan, 700-8558
    - Recruiting
    - Research Site
  - Okayama-shi, Japan, 700-8607
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Recruiting
    - Research Site
  - Sapporo-shi, Japan, 060-8543
    - Recruiting
    - Research Site
  - Sasebo-shi, Japan, 857-1195
    - Recruiting
    - Research Site
  - Sendai-shi, Japan, 980-8574
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Recruiting
    - Research Site
  - Takatsuki-shi, Japan, 569-8686
    - Recruiting
    - Research Site
  - Tsu-shi, Japan, 514-8507
    - Recruiting
    - Research Site
  - Tsukuba-shi, Japan, 305-8576
    - Recruiting
    - Research Site
Mexico
- - Chihuahua, Mexico, 31000
    - Recruiting
    - Research Site
  - Culiacan, Mexico, 80000
    - Recruiting
    - Research Site
  - Durango, Mexico, 43080
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44130
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44650
    - Active, not recruiting
    - Research Site
  - Guadalajara, Mexico, 44950
    - Recruiting
    - Research Site
  - Merida, Mexico, 97000
    - Recruiting
    - Research Site
  - Merida, Mexico, 97070
    - Active, not recruiting
    - Research Site
  - Mexicali, Mexico, 21200
    - Recruiting
    - Research Site
  - Mexico, Mexico, 03100
    - Recruiting
    - Research Site
  - Mexico, Mexico, 03720
    - Recruiting
    - Research Site
  - Mexico, Mexico, 06700
    - Recruiting
    - Research Site
Peru
- - Lima, Peru, LIMA 41
    - Withdrawn
    - Research Site
  - Lima, Peru, 15023
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 11
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 29
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 32
    - Withdrawn
    - Research Site
Poland
- - Katowice, Poland, 40-081
    - Recruiting
    - Research Site
  - Koscian, Poland, 64-000
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-033
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-363
    - Recruiting
    - Research Site
  - Kraków, Poland, 30-510
    - Active, not recruiting
    - Research Site
  - Lublin, Poland, 20-607
    - Recruiting
    - Research Site
  - Nowa Sól, Poland, 67-100
    - Recruiting
    - Research Site
  - Ustron, Poland, 43-450
    - Recruiting
    - Research Site
  - Warszawa, Poland, 00-874
    - Recruiting
    - Research Site
  - Warszawa, Poland, 02-118
    - Recruiting
    - Research Site
  - Warszawa, Poland, 02-691
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 50-244
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 50-088
    - Active, not recruiting
    - Research Site
  - Łódź, Poland, 90-368
    - Recruiting
    - Research Site
Russian Federation
- - Moscow, Russian Federation, 115522
    - Withdrawn
    - Research Site
  - Moscow, Russian Federation, 119021
    - Withdrawn
    - Research Site
  - Ryazan, Russian Federation, 390026
    - Withdrawn
    - Research Site
  - Saint-Petersburg, Russian Federation, 190068
    - Withdrawn
    - Research Site
  - Saratov, Russian Federation, 410054
    - Withdrawn
    - Research Site
  - Smolensk, Russian Federation, 214015
    - Withdrawn
    - Research Site
Spain
- - Barcelona, Spain, 8003
    - Recruiting
    - Research Site
  - Barcelona, Spain, 8035
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Active, not recruiting
    - Research Site
  - Madrid, Spain, 28050
    - Recruiting
    - Research Site
  - Madrid, Spain, 28702
    - Recruiting
    - Research Site
  - Santiago de Compostela, Spain, 15706
    - Active, not recruiting
    - Research Site
  - Sevilla, Spain, 41010
    - Recruiting
    - Research Site
  - Valencia, Spain, 46026
    - Recruiting
    - Research Site
Ukraine
- - Cherkasy, Ukraine, 18009
    - Suspended
    - Research Site
  - Kryvyi Rih, Ukraine, 50031
    - Suspended
    - Research Site
  - Kyiv, Ukraine, 01023
    - Withdrawn
    - Research Site
  - Kyiv, Ukraine, 04050
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 01601
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 02091
    - Recruiting
    - Research Site
  - Lviv, Ukraine, 79000
    - Not yet recruiting
    - Research Site
  - Lviv, Ukraine, 79014
    - Suspended
    - Research Site
  - Odesa, Ukraine, 65025
    - Suspended
    - Research Site
  - Odesa, Ukraine, 65026
    - Not yet recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21001
    - Recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - Research Site
  - Zaporizhzhia, Ukraine, 69600
    - Suspended
    - Research Site
United Kingdom
- - Coventry, United Kingdom, CV2 2DX
    - Recruiting
    - Research Site
  - Doncaster, United Kingdom, DN2 5LT
    - Recruiting
    - Research Site
  - Edinburgh, United Kingdom, EH4 2XU
    - Recruiting
    - Research Site
  - Harlow, United Kingdom, CM20 1QX
    - Recruiting
    - Research Site
  - Leeds, United Kingdom, LS7 4SA
    - Recruiting
    - Research Site
  - Leytonstone, United Kingdom, E11 1NR
    - Withdrawn
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Research Site
  - London, United Kingdom, SE5 9NU
    - Recruiting
    - Research Site
  - Wigan, United Kingdom, WN6 9EP
    - Recruiting
    - Research Site
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Withdrawn
    - Research Site
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - Research Site
- Arizona
  - Paradise Valley, Arizona, United States, 85253
    - Recruiting
    - Research Site
  - Phoenix, Arizona, United States, 85032
    - Recruiting
    - Research Site
- California
  - El Cajon, California, United States, 92020
    - Recruiting
    - Research Site
  - Hemet, California, United States, 92543
    - Recruiting
    - Research Site
  - La Mesa, California, United States, 91942
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90095
    - Recruiting
    - Research Site
  - Menifee, California, United States, 92586
    - Recruiting
    - Research Site
  - Moreno Valley, California, United States, 92553
    - Recruiting
    - Research Site
  - Upland, California, United States, 91786
    - Recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Research Site
  - Denver, Colorado, United States, 80230
    - Recruiting
    - Research Site
- Florida
  - Boynton Beach, Florida, United States, 33472
    - Recruiting
    - Research Site
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33759
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Active, not recruiting
    - Research Site
  - Hialeah, Florida, United States, 33016
    - Withdrawn
    - Research Site
  - Miami, Florida, United States, 33180
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33613
    - Withdrawn
    - Research Site
  - Tampa, Florida, United States, 33614
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33606
    - Not yet recruiting
    - Research Site
  - Tampa, Florida, United States, 33613
    - Completed
    - Research Site
- Georgia
  - Decatur, Georgia, United States, 30033
    - Recruiting
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Not yet recruiting
    - Research Site
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Completed
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
- Michigan
  - Flint, Michigan, United States, 48504
    - Recruiting
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63119
    - Recruiting
    - Research Site
- New Jersey
  - Newark, New Jersey, United States, 07103
    - Recruiting
    - Research Site
  - Voorhees, New Jersey, United States, 08043
    - Recruiting
    - Research Site
- New Mexico
  - Las Cruces, New Mexico, United States, 88011
    - Recruiting
    - Research Site
- New York
  - Bronx, New York, United States, 10461
    - Not yet recruiting
    - Research Site
  - Brooklyn, New York, United States, 11201
    - Recruiting
    - Research Site
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Research Site
  - New Hyde Park, New York, United States, 11042
    - Recruiting
    - Research Site
  - New York, New York, United States, 10032
    - Recruiting
    - Research Site
  - Potsdam, New York, United States, 13676
    - Recruiting
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Research Site
  - Charlotte, North Carolina, United States, 28203
    - Recruiting
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15224
    - Recruiting
    - Research Site
  - Reading, Pennsylvania, United States, 19610
    - Completed
    - Research Site
- Tennessee
  - Memphis, Tennessee, United States, 38119
    - Recruiting
    - Research Site
- Texas
  - Austin, Texas, United States, 78745
    - Withdrawn
    - Research Site
  - El Paso, Texas, United States, 79902
    - Not yet recruiting
    - Research Site
  - Grapevine, Texas, United States, 76051
    - Completed
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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:
1. BILAG2004 level A disease in ≥ 1 organ system
2. 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.
Exclusion Criteria:
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
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:
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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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

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 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.	At week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first BICLA response sustained through Week 52 Time Frame: Baseline through to 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) Time Frame: At week 52	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 Time Frame: Baseline through to Week 52	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. Time Frame: At week 52	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 Time Frame: Baseline through to Week 52	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 Time Frame: At week 52	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 Time Frame: Up to 2 years 4 months	Overview of AEs, SAEs and AESIs	Up to 2 years 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Estimated)

August 11, 2025

Study Completion (Estimated)

November 16, 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)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

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Clinical Trials on Systemic Lupus Erythematosus

Sanofi

Completed

Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Japan
Kyowa Kirin Co., Ltd.

Recruiting

A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

Healthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)

Japan
Second Xiangya Hospital of Central South University
National Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaborators

Active, not recruiting

Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus

Cutaneous Lupus Erythematosus | Systemic Lupus Erythematosus Rash

China
University Hospital, Brest

Recruiting

3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 (3TR-SLE2)

Systemic Lupus Erythematosus (SLE)

France
Beijing InnoCare Pharma Tech Co., Ltd.

Recruiting

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus, SLE

China
TJ Biopharma Co., Ltd.

Terminated

A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

China
AstraZeneca

Active, not recruiting

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Active Systemic Lupus Erythematosus

Thailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
Novartis Pharmaceuticals

Active, not recruiting

Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

Systemic Lupus Erythematosus (SLE)

Hungary, Spain, Germany, Israel, Thailand, France, Russian Federation, China, Japan, Taiwan, Korea, Republic of, Poland, Australia, Argentina, Czechia
AstraZeneca
PRA Health Sciences

Completed

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

United States, France, Germany, Spain, Belgium, Russian Federation, Japan, Korea, Republic of, Argentina, Bulgaria, South Africa, Mexico, Canada, Brazil, Lithuania
Novartis Pharmaceuticals

Not yet recruiting

An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus, SLE

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Italfarmaco

Completed

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

Becker Muscular Dystrophy

Netherlands, Italy
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
West Penn Allegheny Health System

Completed

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma | Allergic Rhinitis

United States

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

Study Overview

Status

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Accepts Healthy Volunteers

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on Placebo

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