Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal

Criteria

Key Inclusion Criteria:

1. Adult patients from 18 to 70 years of age inclusive

2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria

3. Limited or diffuse cutaneous subsets

4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF

5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points

6. mRSS > 10 with early disease or rapid progression as defined by the protocol

7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol

8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus

9. Women of childbearing potential with a negative urine pregnancy test

10. Uninvolved skin at injection sites

Key Exclusion Criteria:

1. Anticentromere antibody seropositivity on central laboratory

2. Severe cardiopulmonary disease as defined by the protocol

3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min/1.73m2)

4. 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)

5. 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

6. 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

7. Hematopoietic stem cell transplantation or solid organ/limb transplantation

8. Any severe case of Herpes Zoster infection as defined by the protocol

9. 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

10. Major surgery within 8 weeks prior to and/or during study enrollment

11. Known active current or history of recurrent infections

12. 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