Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
DAISY
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
2 other identifiers
interventional
314
23 countries
151
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2023
Typical duration for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 5, 2028
April 20, 2026
April 1, 2026
3.2 years
June 2, 2023
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
at Week 52
Secondary Outcomes (16)
Change from baseline in mRSS
at Week 52
Number of patients with improvement in individual revised Composite Response Index in Systemic Sclerosis (CRISS-25)
at Week 52
Change from baseline in chest computed tomography imaging
at Week 52
Change from baseline in Scleroderma Skin Patient Reported Outcome
at Week 52
Change from baseline in FVC
at Week 52
- +11 more secondary outcomes
Study Arms (2)
Anifrolumab (subcutaneous weekly injection)
EXPERIMENTALAnifrolumab subcutaneous injection once weekly
matched placebo control (subcutaneous weekly injection)
PLACEBO COMPARATORmatched placebo control subcutaneous injection once weekly
Interventions
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
matched placebo delivered subcutaneously, once weekly for 52 weeks
At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
Eligibility Criteria
You may qualify if:
- 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 at the time of signing the ICF
- 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, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
- Women of childbearing potential with a negative urine pregnancy test
- Uninvolved skin at injection sites
You may not qualify if:
- 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/1.73m2)
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (151)
Research Site
Scottsdale, Arizona, 85259, United States
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Chula Vista, California, 91910, United States
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Los Angeles, California, 90095, United States
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Orange, California, 92868, United States
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Aurora, Colorado, 80045, United States
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New Haven, Connecticut, 06519, United States
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Washington D.C., District of Columbia, 20007, United States
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Boca Raton, Florida, 33486, United States
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Fort Lauderdale, Florida, 33309, United States
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Gainesville, Florida, 32603, United States
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Jacksonville, Florida, 32216, United States
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Margate, Florida, 33063, United States
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South Miami, Florida, 33143, United States
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Tamarac, Florida, 33321, United States
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Chicago, Illinois, 60611, United States
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Kansas City, Kansas, 66160, United States
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New Orleans, Louisiana, 70121, United States
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Baltimore, Maryland, 21224, United States
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Ann Arbor, Michigan, 48109, United States
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Rochester, Minnesota, 55905, United States
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Babylon, New York, 11702, United States
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New York, New York, 10032, United States
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Cincinnati, Ohio, 45219, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Allen, Texas, 75013, United States
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Houston, Texas, 77030, United States
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Ghent, B-9000, Belgium
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Leuven, 3000, Belgium
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Calgary, Alberta, T2N 4Z6, Canada
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Toronto, Ontario, M5T 3L9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, G1V 3M7, Canada
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Beijing, 100191, China
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Beijing, CN-100730, China
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Guangzhou, 510100, China
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Guangzhou, 510530, China
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Hangzhou, 310014, China
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Lanzhou, 730000, China
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Shanghai, 200032, China
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Shanghai, 201210, China
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Tianjin, 300050, China
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Bordeaux, 33076, France
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Brest, 29609, France
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Paris, 75020, France
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Paris, 75679, France
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Rennes, 35033, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Freiburg im Breisgau, 79106, Germany
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Mainz, 55131, Germany
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Minden, 32429, Germany
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Münster, 48149, Germany
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Tübingen, 72076, Germany
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Budapest, 1023, Hungary
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Budapest, 1027, Hungary
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Budapest, 1138, Hungary
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Debrecen, 4032, Hungary
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Pécs, 7632, Hungary
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Szeged, 6725, Hungary
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Ahmedabad, 380006, India
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Delhi, 110060, India
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Gurugram, 122001, India
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Hyderabad, 500082, India
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Kolkata, 700020, India
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Mumbai, 400053, India
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Mysuru, 570004, India
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New Delhi, 11029, India
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Pune, 411001, India
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Secunderabad, 500003, India
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Afula, 18101, Israel
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Haifa, 31048, Israel
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Haifa, 31096, Israel
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Jerusalem, 00000, Israel
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Kfar Saba, 4428164, Israel
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Ramat Gan, 52621, Israel
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Ancona, 60126, Italy
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Brescia, 25123, Italy
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Cona, 44124, Italy
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Milan, 20122, Italy
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Padova, 35128, Italy
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Roma, 00128, Italy
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Roma, 00168, Italy
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Roma, 161, Italy
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Bunkyō City, 113-8603, Japan
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Fukuoka, 812-8582, Japan
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Iruma-Gun, 350-0495, Japan
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Kanazawa, 920-8641, Japan
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Maebashi, 371-8511, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 457-0866, Japan
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Sapporo, 060-8638, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-8582, Japan
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Shinjuku-ku, 162-8666, Japan
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Suita-shi, 565-0871, Japan
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Takatsuki-shi, 569-8686, Japan
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Toyoake-shi, 470-1192, Japan
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Yokohama, 236-0004, Japan
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Seremban, 70300, Malaysia
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Chihuahua City, 31000, Mexico
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Guadalajara, 44158, Mexico
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Guadalajara, 44650, Mexico
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Mexico City, 06700, Mexico
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San Luis Potosí City, 78213, Mexico
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San Luis Potosí City, 78250, Mexico
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Groningen, 9713 GZ, Netherlands
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Bydgoszcz, 85-168, Poland
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Krakow, 30-002, Poland
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Krakow, 30-721, Poland
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Lodz, 90-549, Poland
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Sosnowiec, 41-200, Poland
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Warsaw, 00-874, Poland
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Bucharest, 011172, Romania
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Bucharest, 020475, Romania
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Cluj-Napoca, 400006, Romania
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Iași, 700661, Romania
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Parktown, 2193, South Africa
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Pretoria, South Africa
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Busan, 49241, South Korea
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Seoul, 03080, South Korea
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Seoul, 04401, South Korea
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Seoul, 04763, South Korea
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Seoul, 137-701, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08003, Spain
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Barcelona, 08041, Spain
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Madrid, 28041, Spain
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Málaga, 29009, Spain
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Valencia, 46017, Spain
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Valencia, 46026, Spain
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Center, 23200, Turkey (Türkiye)
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Kazımkarabekir, 01230, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Cannock, WS11 2XY, United Kingdom
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Leeds, LS7 4SA, United Kingdom
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London, NW3 2QG, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh, 70000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2023
First Posted
June 29, 2023
Study Start
November 8, 2023
Primary Completion (Estimated)
January 6, 2027
Study Completion (Estimated)
April 5, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.