Resumen

Este estudio investiga la eficacia y seguridad de belimumab en comparación con placebo, además de la terapia estándar, para el tratamiento de participantes con esclerosis sistémica asociada a enfermedad pulmonar intersticial (ES-EPI). El estudio evaluará el efecto del tratamiento con belimumab sobre la función pulmonar, así como sobre las manifestaciones extrapulmonares de la enfermedad, incluyendo el engrosamiento cutáneo y los síntomas generales, como la fatiga, que afectan la calidad de vida (CdV).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participant is 18 years of age inclusive, or older at the time of signing the informed consent.
Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.
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.
Total mRSS ≥15 on Day 1.
Evidence of interstitial lung disease on centrally read screening HRCT.
Anticentromere antibody negative on central test at screening.
Evidence for active or progressive disease
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.
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.
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.
Capable of giving signed informed consent.

Criterios de exclusión

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).
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.
FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.
Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).
SSc renal crisis within 6 months prior to the first day of dosing (Day 1).
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.
Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC \<0.7).
Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).
Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).
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.
Treatment with rituximab within 6 months prior to Day 1.
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.
Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.
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.
Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.
Treatment with IM or IV corticosteroids within 1 month prior to Day 1.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

Estudio de fase 2/3, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de belimumab administrado por vía subcutánea en adultos con esclerosis sistémica asociada a enfermedad pulmonar intersticial (ES-EPI)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Belimumab

Placebo

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores

Contactos

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center