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.
Inclusion Criteria:
1. Participant is 18 years of age inclusive, or older at the time of signing the informed
consent.
2. Documented diagnosis of SSc as defined by the American College of Rheumatology /
European League Against Rheumatism 2013 SSc classification criteria.
3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at
least one skin area proximal to elbows and/or knees in addition to distal areas
involvement on Day 1.
4. Total mRSS ≥15 on Day 1.
5. Evidence of interstitial lung disease on centrally read screening HRCT.
6. Anticentromere antibody negative on central test at screening.
7. Evidence for active or progressive disease
8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of
the investigator, would allow SC injection at the abdomen or the front, middle region
of the thigh.
9. Participant is capable and willing to self-administer the study medication or has a
caregiver who is capable and willing to administer the study medication throughout the
study.
10. A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies:
Is a Woman of Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing
Potential (WOCBP) and using a contraceptive method that is highly effective.
11. Capable of giving signed informed consent.
Exclusion Criteria:
1. Systemic sclerosis-like illness, including but not limited to localized scleroderma
(morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro
mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that
are associated with environmental chemical and drug exposure (e.g., toxic rapeseed
oil, vinyl chloride, bleomycin, gadolinium-based contrast agents [nephrogenic systemic
fibrosis], or due to metabolic disease).
2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but
not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis,
dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or
mixed connective tissue disease, as determined by the investigator.
3. FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or
requiring supplemental oxygen at screening.
4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to
first day of dosing (Day 1).
5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
endocrine, hematologic, or neurological disorders capable of significantly altering
the absorption, metabolism, or elimination of drugs; constituting a risk when taking
the study intervention or interfering with the interpretation of data.
7. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC <0.7).
8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone
marrow transplant (e.g., autologous stem cell transplant).
10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal
antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is
longer) prior to dosing.
11. Treatment with rituximab within 6 months prior to Day 1.
12. Treatment with non-biologic systemic immunosuppressive medication, other than
mycophenolate, methotrexate or azathioprine (including, but not limited to
cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK)
inhibitors) within 3 months prior to Day 1.
13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.
14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or
tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4
weeks prior to Day 1.
15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents
within 6 months of Day 1.
16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/27/23. Questions regarding updates should be directed to the study team contact.