PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease

Overview

Información sobre este estudio

The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

Elegibilidad para la participación

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:

- Confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.

- Diffuse cutaneous scleroderma

- Systemic sclerosis related interstitial lung disease confirmed by HRCT

- FVC ≥ 45% of predicted normal

- Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal

- Stable dosing of nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) or
azathioprine, as well corticosteroids

- Able to provide written informed consent and understand and comply with the
requirements of the study

Exclusion Criteria:

- WOCBP and men with female partners of childbearing potential who are unwilling or
unable to use two highly effective methods of contraception to avoid pregnancy for the
entire study period and for up to 12 weeks after the last dose of study drug

- Airway obstruction per pulmonary function test (PFT) or clinically significant
pulmonary arterial hypertension

- Current clinical diagnosis of another inflammatory connective tissue disease

- Any active infections, a serious infection within the past 3 months, or chronic
bacterial infection

- Current smoker or smoking within 6 months of screening

- Subjects in the opinion of the investigator that are an an unacceptable risk for
participation in the study

- Subjects who meet the protocol criteria for important laboratory exclusion criteria

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/7/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Vivek Nagaraja, M.B.B.S., M.D.

Abierto para la inscripción

Contact information:

Shan Luc-Kenney R.N.

(480) 301-9769

Luc-Kenney.Shan@mayo.edu

More information

Publicaciones

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