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

Primary Purpose

Active Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Anifrolumab
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Systemic Lupus Erythematosus

Eligibility Criteria

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

Key inclusion criteria:

  1. Aged 18 to 70 years.
  2. Body weight ≥ 40 kg.
  3. Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
  4. Must be receiving at least one of the following SOC regimens at screening:

    1. oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for > 2 weeks;
    2. Immunosuppressant(s) with or without OCS: antimalarials, AZA, MMF, MTX, mizoribine permitted; stable for ≥ 8 weeks; maximum dose required;
    3. Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
  5. At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
  6. SLEDAI-2K score ≥ 6 points at screening and "Clinical" SLEDAI-2K score ≥4 points at both screening and Day1(randomisation), and BILAG with at least 1 level A organ system or 2 level B organ system, and PGA score ≥ 1.0 at screening.
  7. Chest imaging shows no clinically significant abnormalities (unless due to SLE).
  8. No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist.
  9. All participants should use effective contraception methods as protocol requests.
  10. Any negative SARS-CoV-2 RT-PCR test result at screening and no known or suspected COVID-19 infection or exposure within 2 weeks prior to screening and between screening and randomisation visits.

Key exclusion criteria:

  1. History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
  2. History or evidence of suicidal ideation or suicidal behavior.
  3. History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
  4. History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
  5. History of immunodeficient condition, HIV positive included.
  6. Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable, or hepatitis C antibody positive.
  7. History of severe case of herpes zoster.
  8. Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.
  9. Acute COVID-19 infection or history of severe COVID-19.
  10. History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ.
  11. Women participants with abnormal pap smear results.
  12. Prior receipt of anifrolumab ,or any commercially available biologic agent, or protein kinase inhibitor or any investigational product within 5 half-lives, including B cell-depleting therapy, belimumab, JAK or BTK inhibitor.
  13. Known history of allergy to any component of the IP formulation or protein related products.
  14. Receipt of any of the following:

    1. Intramuscular or IV glucocorticosteroids within 6 weeks;
    2. Any live or attenuated vaccine within 8 weeks;
    3. Any restricted medication listed in protocol;
    4. Blood transfusion within 4 weeks. 15 Regular use of > 1 NSAID within 2 weeks or receipt of fluctuating doses of a NSAID within 2 weeks.

16. Certain laboratory test results requirements. 17. Concurrent enrolment in another clinical study. 18. History or current alcohol, drug or chemical abuse within 1 year. 19. Major surgery within 8 weeks or planned elective major surgery.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

anifrolumab

Arm Description

Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.

Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.

Outcomes

Primary Outcome Measures

Difference in proportion of participants who are responders between anifrolumab and placebo
Composite endpoint (BICLA),a composite binary endpoint defined by meeting all of the following criteria: 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 participants' lupus disease activity, where worsening is defined as an increase of ≥0.30 points on a 3-point PGA visual analogue scale (VAS) No discontinuation of investigational product No use of restricted medications beyond the protocol allowed threshold a before assessment

Secondary Outcome Measures

The proportion of participants who achieve Systemic Lupus Erythematosus Responder Index of ≥4 (SRI(4)) response
SRI(4) response 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; No worsening from baseline in the participants' lupus disease activity defined by 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 a before assessment
The proportion of participants who achieve an oral corticosteroid (OCS) dose ≤7.5 mg/day at Week 40, which is maintained through Week 52 in the subgroup of those with baseline OCS ≥10 mg/day
Maintained OCS reduction 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 a before assessment
The proportion of participants with a ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score at Week 12 in the sub-group of those with baseline CLASI activity score ≥10
50% reduction in CLASI activity score compared to baseline defined by meeting all of the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product No use of restricted medications beyond the protocol allowed threshold a before assessment
Annualized flare rate
Annualised flare rate with flare defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit

Full Information

First Posted
April 29, 2021
Last Updated
July 27, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04931563
Brief Title
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
Official Title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
April 25, 2025 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).
Detailed Description
This is a Phase III, multicenter, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg anifrolumab versus placebo in participants with moderate to severe, autoantibody positive SLE while receiving SOC treatment. The study will be performed in participants aged 18 to 70 years of age. Participants with a confirmed diagnosis of moderate to severe active SLE and are currently receiving SOC comprising of oral corticosteroids (OCSs) and/or antimalarial, and/or immunosuppressants, either alone or any combination of them, for a required duration of treatment at a stable dose, as described in the inclusion criteria shall be included. Participants must have eligible scores for SLEDAI-2K, BILAG-2004, and PGA as confirmed by the DACRT. Eligible participants will be randomised in a 1:1 ratio to receive either a fixed intravenous dose of 300 mg anifrolumab plus SOC or placebo plus SOC every 4 weeks (Q4W) for a total of 13 doses (Week 0 to Week 48), with the primary endpoint evaluated at the Week 52 visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Arm Title
anifrolumab
Arm Type
Active Comparator
Arm Description
Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Intervention Type
Biological
Intervention Name(s)
Anifrolumab
Intervention Description
Intravenous infusion (IV)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Intravenous infusion (IV)
Primary Outcome Measure Information:
Title
Difference in proportion of participants who are responders between anifrolumab and placebo
Description
Composite endpoint (BICLA),a composite binary endpoint defined by meeting all of the following criteria: 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 participants' lupus disease activity, where worsening is defined as an increase of ≥0.30 points on a 3-point PGA visual analogue scale (VAS) No discontinuation of investigational product No use of restricted medications beyond the protocol allowed threshold a before assessment
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
The proportion of participants who achieve Systemic Lupus Erythematosus Responder Index of ≥4 (SRI(4)) response
Description
SRI(4) response 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; No worsening from baseline in the participants' lupus disease activity defined by 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 a before assessment
Time Frame
Week 52
Title
The proportion of participants who achieve an oral corticosteroid (OCS) dose ≤7.5 mg/day at Week 40, which is maintained through Week 52 in the subgroup of those with baseline OCS ≥10 mg/day
Description
Maintained OCS reduction 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 a before assessment
Time Frame
Week 52
Title
The proportion of participants with a ≥50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score at Week 12 in the sub-group of those with baseline CLASI activity score ≥10
Description
50% reduction in CLASI activity score compared to baseline defined by meeting all of the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product No use of restricted medications beyond the protocol allowed threshold a before assessment
Time Frame
Week 12
Title
Annualized flare rate
Description
Annualised flare rate with flare defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria: Aged 18 to 70 years. Body weight ≥ 40 kg. Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks. Must be receiving at least one of the following SOC regimens at screening: oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for > 2 weeks; Immunosuppressant(s) with or without OCS: antimalarials, AZA, MMF, MTX, mizoribine permitted; stable for ≥ 8 weeks; maximum dose required; Oral prednisone plus immunosuppressant: start date, stability and maximum dose required. At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith. SLEDAI-2K score ≥ 6 points at screening and "Clinical" SLEDAI-2K score ≥4 points at both screening and Day1(randomisation), and BILAG with at least 1 level A organ system or 2 level B organ system, and PGA score ≥ 1.0 at screening. Chest imaging shows no clinically significant abnormalities (unless due to SLE). No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist. All participants should use effective contraception methods as protocol requests. Any negative SARS-CoV-2 RT-PCR test result at screening and no known or suspected COVID-19 infection or exposure within 2 weeks prior to screening and between screening and randomisation visits. Key exclusion criteria: History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid. History or evidence of suicidal ideation or suicidal behavior. History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE. History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment. History of immunodeficient condition, HIV positive included. Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable, or hepatitis C antibody positive. History of severe case of herpes zoster. Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening. Acute COVID-19 infection or history of severe COVID-19. History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ. Women participants with abnormal pap smear results. Prior receipt of anifrolumab ,or any commercially available biologic agent, or protein kinase inhibitor or any investigational product within 5 half-lives, including B cell-depleting therapy, belimumab, JAK or BTK inhibitor. Known history of allergy to any component of the IP formulation or protein related products. Receipt of any of the following: Intramuscular or IV glucocorticosteroids within 6 weeks; Any live or attenuated vaccine within 8 weeks; Any restricted medication listed in protocol; Blood transfusion within 4 weeks. 15 Regular use of > 1 NSAID within 2 weeks or receipt of fluctuating doses of a NSAID within 2 weeks. 16. Certain laboratory test results requirements. 17. Concurrent enrolment in another clinical study. 18. History or current alcohol, drug or chemical abuse within 1 year. 19. Major surgery within 8 weeks or planned elective major surgery.
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
Baoding
ZIP/Postal Code
071000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baotou
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100144
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bengbu
ZIP/Postal Code
233060
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Binzhou
ZIP/Postal Code
256603
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130033
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Changchun
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
430033
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changzhi
ZIP/Postal Code
46000
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chuangchun
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guilin
ZIP/Postal Code
541001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hengyang
ZIP/Postal Code
50012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jieyang
ZIP/Postal Code
522000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jining
ZIP/Postal Code
272011
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linyi
ZIP/Postal Code
276003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Luoyang
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nan Chong
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Terminated
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanyang
ZIP/Postal Code
473005
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shengyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shijiazhuang
ZIP/Postal Code
050001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Urumqi
ZIP/Postal Code
831118
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xinxiang
ZIP/Postal Code
453002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaozhuang City
ZIP/Postal Code
277102
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shatin
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jung-gu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Davao City
ZIP/Postal Code
PH-8000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 deidentified 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

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

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