NCT lookup

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

• Scottsdale, Arizona, United States
• Chula Vista, California, United States
• Los Angeles, California, United States
• Orange, California, United States
• Aurora, Colorado, United States
• New Haven, Connecticut, United States
• Washington D.C., District of Columbia, United States
• Boca Raton, Florida, United States
• Fort Lauderdale, Florida, United States
• Gainesville, Florida, United States
• Jacksonville, Florida, United States
• Margate, Florida, United States
• South Miami, Florida, United States
• Tamarac, Florida, United States
• Chicago, Illinois, United States
• Kansas City, Kansas, United States
• New Orleans, Louisiana, United States
• Baltimore, Maryland, United States
• Ann Arbor, Michigan, United States
• Rochester, Minnesota, United States
• Babylon, New York, United States
• New York, New York, United States
• Cincinnati, Ohio, United States
• Pittsburgh, Pennsylvania, United States
• Allen, Texas, United States
• Houston, Texas, United States
• Graz, Austria
• Innsbruck, Austria
• Vienna, Austria
• Ghent, Belgium
• + 120 more on CT.gov