EUCTR2017-003158-18-ES
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- mild to moderate Idiopathic Pulmonary Fibrosis
- Sponsor
- Biogen Idec Research Limited
- Enrollment
- 290
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Female subjects must be surgically sterile,
- •postmenopausal (minimum 1 year without menses), or
- •agree to use 1 or more forms of highly effective
- •contraception from the time of signing of the informed
- •consent form (ICF) until 3 months after the last injection
- •of study medication. Male subjects must also agree to
- •use 1 or more forms of highly effective contraception for
- •either themselves or their partners from signing of ICF
- •until 4 months after last injection of study medication.
- •\- Diagnosed with Idiopathic pulmonary fibrosis (IPF).
Exclusion Criteria
- •\- Unable to perform pulmonary functional tests (PFTs) or
- •undergo HRCT procedure.
- •\- Peripheral capillary oxygen saturation (SpO2\) \<90% at
- •rest (if on oxygen supplementation, must be \=2 L/min at
- •\- Airway obstruction (i.e., prebronchodilator FEV1/FVC
- •\<0\.7\) or evidence of a bronchodilator response as
- •defined by an absolute increase of \=12% and an
- •increase of \=200 milliliters (mL) in FEV1 or FVC, or both,
- •after bronchodilator use, compared with the values
- •before bronchodilator use at Screening.
Outcomes
Primary Outcomes
Not specified
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