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

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Medi-546
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion CriteriaErythematosus

  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).

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anifrolumab

Placebo

Arm Description

Solution for injection in aPFS

Solution for injection in aPFS

Outcomes

Primary Outcome Measures

British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
The primary endpoint is response in BICLA, 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. No discontinuation of investigational product. No use of restricted medications beyond the protocol-allowed threshold.

Secondary Outcome Measures

Time to first BICLA response sustained through Week 52
Time from first dose to first BICLA response that is consecutively maintained through 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.
BICLA response
Same definition as primary outcome measure.
Time to flare
Flare defined as either 1 or more BILAG 2004 A or 2 or more BILAG 2004 B compared to previous visit
≥ 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score in the sub-group of patients with baseline CLASI activity score ≥ 10
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
Change in the number of swollen and tender joints compared to baseline among patients with ≥ 6 swollen and ≥ 6 tender joints at baseline.
Achieving a change in number of swollen and tender joints is defined by meeting all of the following criteria: ≥ 50% change in the number of swollen and ≥ 50% change in the number of tender joints No discontinuation of IP No use of restricted medications beyond the protocol allowed threshold before assessment
Annualized flare rate
Flare defined as either 1 or more BILAG 2004 or 2 or more BILAG2004 B compared to previous visit
Systemic Lupus Erythematosus Responder Index of ≥ 4 (SRI[4]) response
Response is 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 No discontinuation of IP No use of restricted medications beyond the protocol allowed threshold before assessment
Chronic Illness Therapy-FATIGUE (FACIT-F) score

Full Information

First Posted
May 4, 2021
Last Updated
June 16, 2023
Sponsor
AstraZeneca
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04877691
Brief Title
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Acronym
Tulip SC
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
August 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Double Blind (Participant, Care Provider and Investigator)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anifrolumab
Arm Type
Experimental
Arm Description
Solution for injection in aPFS
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Solution for injection in aPFS
Intervention Type
Drug
Intervention Name(s)
Medi-546
Intervention Description
Patients will have IP administered or will self-administer IP under supervision by site staff at Weeks 0, 1, and 2. 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, as follows: - W0 and W1 - 1 kit to be administered at clinic - W2 - 3 kits (1 to be administered at clinic, 2 to be taken home) - W4 - W48 (every 4 weeks) - 5 kits (1 to be administered at clinic, 4 to be taken home) Patients will have approximately 65 kits (including back-up kits) dispensed to them over the course of the 52-week treatment period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for injection in aPFS
Primary Outcome Measure Information:
Title
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Description
The primary endpoint is response in BICLA, 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. No discontinuation of investigational product. No use of restricted medications beyond the protocol-allowed threshold.
Time Frame
At week 52
Secondary Outcome Measure Information:
Title
Time to first BICLA response sustained through Week 52
Description
Time from first dose to first BICLA response that is consecutively maintained through Week 52
Time Frame
Baseline through to Week 52
Title
BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)
Description
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.
Time Frame
At week 52
Title
BICLA response
Description
Same definition as primary outcome measure.
Time Frame
At week 16
Title
Time to flare
Description
Flare defined as either 1 or more BILAG 2004 A or 2 or more BILAG 2004 B compared to previous visit
Time Frame
Baseline through to Week 52
Title
≥ 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score in the sub-group of patients with baseline CLASI activity score ≥ 10
Time Frame
At week 12
Title
Maintained oral corticosteroid (OCS) reduction among patients with baseline OCS ≥10 mg/day.
Description
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
Time Frame
At week 52
Title
Change in the number of swollen and tender joints compared to baseline among patients with ≥ 6 swollen and ≥ 6 tender joints at baseline.
Description
Achieving a change in number of swollen and tender joints is defined by meeting all of the following criteria: ≥ 50% change in the number of swollen and ≥ 50% change in the number of tender joints No discontinuation of IP No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame
At week 52
Title
Annualized flare rate
Description
Flare defined as either 1 or more BILAG 2004 or 2 or more BILAG2004 B compared to previous visit
Time Frame
Baseline through to Week 52
Title
Systemic Lupus Erythematosus Responder Index of ≥ 4 (SRI[4]) response
Description
Response is 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 No discontinuation of IP No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame
At week 52
Title
Chronic Illness Therapy-FATIGUE (FACIT-F) score
Time Frame
At week 52
Other Pre-specified Outcome Measures:
Title
Adverse Event Overview
Description
Overview of AEs, SAEs and AESIs
Time Frame
Baseline through Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion CriteriaErythematosus 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. 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: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92553
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quilmes
ZIP/Postal Code
B1878GEG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000PBJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salta
ZIP/Postal Code
A4400ANW
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Isidro
ZIP/Postal Code
1643
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
T4000ICL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Osorno
ZIP/Postal Code
5290000
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500010
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500571
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7501126
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080002
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kirchheim
ZIP/Postal Code
73230
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8712
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamamatsu-shi
ZIP/Postal Code
430-0906
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
807-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Meguro-ku
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Meguro-ku
ZIP/Postal Code
153-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sagamihara-shi
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sasebo-shi
ZIP/Postal Code
857-1195
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsukuba-shi
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Culiacan
ZIP/Postal Code
80000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Durango
ZIP/Postal Code
43080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexicali
ZIP/Postal Code
21200
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
03720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15023
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 32
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 41
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ustron
ZIP/Postal Code
43-450
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-244
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Smolensk
ZIP/Postal Code
214015
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kryvyi Rih
ZIP/Postal Code
50031
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79014
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leytonstone
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wigan
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

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