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Evaluating the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

Evaluating the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

This Phase 2b study is designed to evaluate the treatment effect (change in forced vital capacity [FVC]) of a single dose of BG00011 (56 mg) administered subcutaneously (SC) once weekly for 52 weeks in subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who may or may not be receiving protocol-defined background therapies (i.e., nintedanib or pirfenidone).

Study duration for an individual subject is approximately 65 weeks, including a Screening Visit
up to 5 weeks prior to the first dose of study treatment, a Placebo-Controlled Treatment Period of
52 weeks, and a Safety Follow-Up Visit 8 weeks after the end of the Treatment Period.

Participant Eligibility

Aged ≥40 years

IPF diagnosed within 3 years of Screening

DLco (corrected for Hgb): 30%-79% of predicted

FVC ≥50% of predicted

Oxygen saturation ≥90% at rest

On a stable dose for nintedanib or pirfenidone at least 8 weeks prior to randomization

Contact

Mory Mehrtash
(206) 502-5265

Additional Study Details

Full Study Title
A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

Study ID: 20180027
Start Date: 08/09/2018
End Date: 11/30/2020

Investigator(s)
Dr. Bridget Collins 206.598.3300

Accepts Healthy Volunteers?
No

Study Site(s)

1959 NE Pacific St.
Seattle, Washington 98195



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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