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 - DAISY

Ageishi Yuji0 sites32 target enrollmentNovember 11, 2023

ConditionsSystemic Sclerosis, Scleroderma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Systemic Sclerosis, Scleroderma
Sponsor: Ageishi Yuji
Enrollment: 32
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 11, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Ageishi Yuji

Eligibility Criteria

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
•5\. Either HAQ\-DI score 0\.25 points or more or PtGA score 3 points or more
•6\. mRSS \> 10 with early disease or rapid progression as defined by the protocol
•7\. mRSS 15 or more with disease duration 18 months or more and active disease as defined by the protocol
•8\. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolic sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
•9\. Women of childbearing potential with a negative urine pregnancy test
•10\. Uninvolved skin at injection sites

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)
•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