Resumen

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Descripción detallada

This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.

Elegibilidad

Sexo: ALL

Criterios de inclusión

For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.

Criterios de exclusión

Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
History of smoking within 3 months prior to the first visit in the OLE.
History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
History of severe allergic reaction or anaphylactic reaction to PRM-151.
Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
Prolonged corrected QT interval \> 450 ms (for men) or \> 470 ms (for women) based on the Fridericia correction formula.
Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Intervenciones

drug

PRM-151 (Zinpentraxin Alfa)

Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks. Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo.

Ubicaciones

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Fundacion Respirar (Centro Medico Dra. De Salvo)

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

Córdoba, Argentina

Hospital Universitario Austral

Derqui-Pilar, Argentina

Centro Medico de Enfermedades Respiratorias (CEMER)

Florida, Buenos Aires, Argentina

Centro de estudios respiratorios

Mar del Plata, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

INSARES

Mendoza, Mendoza City, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)