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Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) (DAISY)

Primary Purpose

Systemic Sclerosis, Scleroderma

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Anifrolumab (blinded)
Placebo (blinded)
Anifrolumab (unblinded, open label)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic Sclerosis (SSc), Scleroderma, Anifrolumab, Limited, Diffuse, Cutaneous, Interstitial lung disease (ILD), Autoimmune diseases, Immune system diseases, Immunosuppressants, Systemic Sclerosis interstitial lung disease (SSc- ILD)

Eligibility Criteria

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

Key Inclusion Criteria: Adult patients from 18 to 70 years of age inclusive Systemic sclerosis according to 2013 ACR/EULAR classification criteria Limited or diffuse cutaneous subsets Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points mRSS > 10 with early disease or rapid progression as defined by the protocol mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolic sodium, mycophenolic acid, oral glucocorticoids or tacrolimus Women of childbearing potential with a negative urine pregnancy test Uninvolved skin at injection sites Key Exclusion Criteria: Anticentromere antibody seropositivity on central laboratory Severe cardiopulmonary disease as defined by the protocol History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min) Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis) History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator Hematopoietic stem cell transplantation or solid organ/limb transplantation Any severe case of Herpes Zoster infection as defined by the protocol Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix Major surgery within 8 weeks prior to and/or during study enrollment Known active current or history of recurrent infections Severe cardiopulmonary disease Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anifrolumab (subcutaneous weekly injection)

matched placebo control (subcutaneous weekly injection)

Arm Description

Anifrolumab subcutaneous injection once weekly

matched placebo control subcutaneous injection once weekly

Outcomes

Primary Outcome Measures

Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Number of participants meeting all the criteria: Improvement in at least 2 components (≥5% increase for percent predicted Forced Vital Capacity (FVC) and/or≥25% decrease for Modified Rodnan Skin Score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PtGA), Clinician Global Assessment (CGA) Worsening in no more than one component (≥5% decrease percent predicted FVC and/or≥25% increase for mRSS, HAQ-DI, PtGA, CGA) No significant SSc-related event as defined by: New scleroderma renal crisis New decline in percent predicted FVC≥15% in established interstitial lung disease or new percent predicted FVC below 80% predicted New onset of left ventricular failure requiring treatment New onset of pulmonary arterial hypertension requiring treatment Gastrointestinal dysmotility requiring enteral or parenteral nutrition Digital ischemia with gangrene, amputation, or hospitalization requiring treatment -Otherwise, a participant is a non-responder

Secondary Outcome Measures

Change from baseline in mRSS
Change from baseline in mRSS score. The mRSS scoring ranges from 0 (normal) to 51 (severe).
Number of patients with improvement in individual revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Number of participants who have improvements in the following improvement components, evaluated separately: ≥ 5% increase in percent predicted Forced Vital Capacity (FVC) ≥ 25% decrease in mRSS ≥ 25% decrease in HAQ-DI ≥25% decrease in PtGA ≥25% decrease in CGA
Change from baseline in chest computed tomography imaging
Change from baseline in quantitative interstitial lung disease score
Change from baseline in Scleroderma Skin Patient Reported Outcome
Change from baseline in the Scleroderma Skin Patient Reported Outcome scores
Change from baseline in FVC
Change from baseline in FVC (ml) in patients with interstitial lung disease Change from baseline in FVC (ml) in all patients
Change from baseline in percent predicted FVC
Change from baseline in percent predicted FVC in patients with interstitial lung disease Change from baseline in percent predicted FVC in all patient
Anifrolumab pharmacokinetic parameters in serum
Anifrolumab serum concentrations will be summarised using descriptive statistics at each visit. Due to sparse pharmacokinetic sampling, the pharmacokinetic assessment will be primarily based on observed serum trough concentrations (Ctrough)
Anifrolumab pharmacodynamics via changes in type I IFN 21-gene signature generated from blood
Type I Interferon inducible gene signature will be assessed by a 21-gene assay in whole blood. The suppression of the type I IFN 21-gene signature will be showed as a percent of baseline through study completion, during both the double-blind treatment and open label periods.
Prevalence of anti-drug antibodies to Anifrolumab
Anti-drug antibodies and titer determination in anti-drug antibody positive participants. The presence of neutralizing anti-drug antibodies will also be tested in all anti-drug positive samples.
Incidence of adverse events
Adverse events (non-serious, serious, and adverse event of special interest (AESI)) are assessed as variables of safety and tolerability of anifrolumab. The AESIs are non-opportunistic serious infections, opportunistic infections, malignancy, herpes zoster, Tuberculosis (TB) (including latent TB), injection site reactions, and major adverse cardiac events.
Incidence of abnormal vital signs
Change from baseline of pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment-emergent changes.
Incidence of abnormal laboratory parameters
Changes from baseline in haematology, clinical chemistry and lipid variables will be assessed by visit and treatment including participants with treatment-emergent changes.
Incidence of abnormal ECG findings
Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarised by visit and treatment group including participants with clinically significant abnormal results.
Incidence of abnormal physical exam findings
Changes from baseline in weight (kilograms) will be assessed by visit and treatment and medically significant changes from the screening physical examination will be recorded as adverse events.
Number of subjects with suicidal ideation and behavior and suicide attempts via Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is used to assess suicidal ideation, behavior, and suicide on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior.
Total score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
PHQ-8 is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQD-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms.

Full Information

First Posted
June 2, 2023
Last Updated
June 22, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05925803
Brief Title
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
Acronym
DAISY
Official Title
A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 13, 2023 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (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
Yes
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 treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in the treatment of adult participants with Systemic Sclerosis (SSc) who may be taking one or a combination of protocol-specified standard therapies. The use of one of the following standard immunosuppressant therapies is permitted at a stable dose, but not mandated: hydroxychloroquine, mycophenolate mofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids. MMF or MPA, azathioprine, and methotrexate may be used in combination with hydroxychloroquine and/or low-dose oral glucocorticoids [≤ 10 mg/day]. Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either 120 mg anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors: Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1); MMF or MPA use (yes ,no) at Week 0 (Day 1); and Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (<18 months, ≥ 18 months) at Week 0 (Day 1) Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home. The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below: Screening Period: This may involve one or more visits to the study site. Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo. Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8*, 16, 24, 36, 48 and 52. *The visit at Week 8 may be either by telephone or in person. Open Label Treatment Period: At Week 52, all participants will be given anifrolumab 120 mg (subcutaneous) once weekly for 52 weeks (last dose at Week 103). Participation will involve in-clinic study visits at Weeks 52, 56, 64, 76. 88 and 104. Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit. This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Scleroderma
Keywords
Systemic Sclerosis (SSc), Scleroderma, Anifrolumab, Limited, Diffuse, Cutaneous, Interstitial lung disease (ILD), Autoimmune diseases, Immune system diseases, Immunosuppressants, Systemic Sclerosis interstitial lung disease (SSc- ILD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in a 1:1 ratio to either anifrolumab or matching placebo for 52 weeks (double blind treatment period). At Week 52, all patients will be treated with 120 mg Anifrolumab for 52 weeks (open label treatment period).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind period- masking -everyone will be masked to the treatment allocation during the first 52 weeks Open label period - no masking- beginning at week 52, all participants will receive Anifrolumab for 52 weeks. During the open label period, there is no masking of study treatment, however, the treatment that participants received in the double blind period (first 52 weeks) will remain masked until the end of the study.
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anifrolumab (subcutaneous weekly injection)
Arm Type
Experimental
Arm Description
Anifrolumab subcutaneous injection once weekly
Arm Title
matched placebo control (subcutaneous weekly injection)
Arm Type
Placebo Comparator
Arm Description
matched placebo control subcutaneous injection once weekly
Intervention Type
Biological
Intervention Name(s)
Anifrolumab (blinded)
Other Intervention Name(s)
Treatment arm (blinded)
Intervention Description
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (blinded)
Other Intervention Name(s)
Placebo arm (blinded)
Intervention Description
matched placebo delivered subcutaneously, once weekly for 52 weeks
Intervention Type
Biological
Intervention Name(s)
Anifrolumab (unblinded, open label)
Other Intervention Name(s)
Treatment arm (not blinded)
Intervention Description
At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
Primary Outcome Measure Information:
Title
Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Description
Number of participants meeting all the criteria: Improvement in at least 2 components (≥5% increase for percent predicted Forced Vital Capacity (FVC) and/or≥25% decrease for Modified Rodnan Skin Score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PtGA), Clinician Global Assessment (CGA) Worsening in no more than one component (≥5% decrease percent predicted FVC and/or≥25% increase for mRSS, HAQ-DI, PtGA, CGA) No significant SSc-related event as defined by: New scleroderma renal crisis New decline in percent predicted FVC≥15% in established interstitial lung disease or new percent predicted FVC below 80% predicted New onset of left ventricular failure requiring treatment New onset of pulmonary arterial hypertension requiring treatment Gastrointestinal dysmotility requiring enteral or parenteral nutrition Digital ischemia with gangrene, amputation, or hospitalization requiring treatment -Otherwise, a participant is a non-responder
Time Frame
at Week 52
Secondary Outcome Measure Information:
Title
Change from baseline in mRSS
Description
Change from baseline in mRSS score. The mRSS scoring ranges from 0 (normal) to 51 (severe).
Time Frame
at Week 52
Title
Number of patients with improvement in individual revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Description
Number of participants who have improvements in the following improvement components, evaluated separately: ≥ 5% increase in percent predicted Forced Vital Capacity (FVC) ≥ 25% decrease in mRSS ≥ 25% decrease in HAQ-DI ≥25% decrease in PtGA ≥25% decrease in CGA
Time Frame
at Week 52
Title
Change from baseline in chest computed tomography imaging
Description
Change from baseline in quantitative interstitial lung disease score
Time Frame
at Week 52
Title
Change from baseline in Scleroderma Skin Patient Reported Outcome
Description
Change from baseline in the Scleroderma Skin Patient Reported Outcome scores
Time Frame
at Week 52
Title
Change from baseline in FVC
Description
Change from baseline in FVC (ml) in patients with interstitial lung disease Change from baseline in FVC (ml) in all patients
Time Frame
at Week 52
Title
Change from baseline in percent predicted FVC
Description
Change from baseline in percent predicted FVC in patients with interstitial lung disease Change from baseline in percent predicted FVC in all patient
Time Frame
at Week 52
Title
Anifrolumab pharmacokinetic parameters in serum
Description
Anifrolumab serum concentrations will be summarised using descriptive statistics at each visit. Due to sparse pharmacokinetic sampling, the pharmacokinetic assessment will be primarily based on observed serum trough concentrations (Ctrough)
Time Frame
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
Title
Anifrolumab pharmacodynamics via changes in type I IFN 21-gene signature generated from blood
Description
Type I Interferon inducible gene signature will be assessed by a 21-gene assay in whole blood. The suppression of the type I IFN 21-gene signature will be showed as a percent of baseline through study completion, during both the double-blind treatment and open label periods.
Time Frame
Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104
Title
Prevalence of anti-drug antibodies to Anifrolumab
Description
Anti-drug antibodies and titer determination in anti-drug antibody positive participants. The presence of neutralizing anti-drug antibodies will also be tested in all anti-drug positive samples.
Time Frame
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
Title
Incidence of adverse events
Description
Adverse events (non-serious, serious, and adverse event of special interest (AESI)) are assessed as variables of safety and tolerability of anifrolumab. The AESIs are non-opportunistic serious infections, opportunistic infections, malignancy, herpes zoster, Tuberculosis (TB) (including latent TB), injection site reactions, and major adverse cardiac events.
Time Frame
From screening to follow-up (max 126 weeks)
Title
Incidence of abnormal vital signs
Description
Change from baseline of pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment-emergent changes.
Time Frame
From screening to follow-up (max 126 weeks)
Title
Incidence of abnormal laboratory parameters
Description
Changes from baseline in haematology, clinical chemistry and lipid variables will be assessed by visit and treatment including participants with treatment-emergent changes.
Time Frame
From screening to follow-up (max 126 weeks)
Title
Incidence of abnormal ECG findings
Description
Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarised by visit and treatment group including participants with clinically significant abnormal results.
Time Frame
From screening to end of treatment visit (max 110 weeks)
Title
Incidence of abnormal physical exam findings
Description
Changes from baseline in weight (kilograms) will be assessed by visit and treatment and medically significant changes from the screening physical examination will be recorded as adverse events.
Time Frame
From screening to follow-up (max 126 weeks)
Title
Number of subjects with suicidal ideation and behavior and suicide attempts via Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is used to assess suicidal ideation, behavior, and suicide on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior.
Time Frame
From screening to follow-up (max 126 weeks)
Title
Total score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Description
PHQ-8 is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQD-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms.
Time Frame
From screening to follow-up (max 126 weeks)

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: Adult patients from 18 to 70 years of age inclusive Systemic sclerosis according to 2013 ACR/EULAR classification criteria Limited or diffuse cutaneous subsets Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points mRSS > 10 with early disease or rapid progression as defined by the protocol mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolic sodium, mycophenolic acid, oral glucocorticoids or tacrolimus Women of childbearing potential with a negative urine pregnancy test Uninvolved skin at injection sites Key Exclusion Criteria: Anticentromere antibody seropositivity on central laboratory Severe cardiopulmonary disease as defined by the protocol History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min) Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis) History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator Hematopoietic stem cell transplantation or solid organ/limb transplantation Any severe case of Herpes Zoster infection as defined by the protocol Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix Major surgery within 8 weeks prior to and/or during study enrollment Known active current or history of recurrent infections Severe cardiopulmonary disease Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Site
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Research Site
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
CN-100730
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510100
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510530
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
201210
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Research Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Research Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Research Site
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Research Site
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Research Site
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1138
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Research Site
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Monserrato
ZIP/Postal Code
09042
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Research Site
City
Iruma-Gun
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
060-8638
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Research Site
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Cdmx
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Research Site
City
Ciudad de Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44158
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
ZIP/Postal Code
78290
Country
Mexico
Facility Name
Research Site
City
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Research Site
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-721
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Research Site
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Vigo
ZIP/Postal Code
36214
Country
Spain
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Research Site
City
Merkez
ZIP/Postal Code
23200
Country
Turkey
Facility Name
Research Site
City
Cannock
ZIP/Postal Code
WS11 2XY
Country
United Kingdom
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

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 AstraZeneca disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AstraZeneca group of companies sponsored clinical trials 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. The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymisation and sharing of the requested data or documents. For details of our timelines, please refer 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

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

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