Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.
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, 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.
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).
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. Severe cardiopulmonary disease.
13. 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/22/23. Questions regarding updates should be directed to the study team contact.