EUCTR2017-003158-18-GBActive, not recruitingPhase 1
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - 203PF203
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Biogen Idec Research Limited
- Enrollment
- 290
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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).
- •- Combination of high-resolution computed tomography
- •(HRCT) pattern and, if one has been obtained, surgical
- •lung biopsy pattern, consistent with diagnosis of IPF.
- •- Carbon monoxide diffusion capacity (DLco) (corrected
- •for hemoglobin): 30% to 79% predicted of normal at
- •Screening, with no clinically significant deterioration
- •between the Screening Visit and randomization, as
- •determined by the Investigator.
- •- Forced (expiratory) vital capacity (FVC) =50%
- •predicted of normal at Screening, with no clinically
- •significant deterioration between the Screening Visit and
- •randomization, as determined by the Investigator.
- •- If a subject is taking nintedanib or pirfenidone, they
- •must be on a stable dose for at least 8 weeks prior to
- •randomization.
- •NOTE: Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 203
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.
- •- End-stage fibrotic disease likely requiring organ
- •transplantation within 12 months, or if the subject has
- •initiated active evaluation for organ transplantation.
- •- The extent of emphysema in the lungs exceeds
- •fibrosis, based on central review of HRCT
- •- Body weight <60 kg at Screening.
- •- History of or ongoing malignant disease, including solid
- •tumors and hematologic malignancies, with the
- •exception of basal cell carcinomas, squamous cell
- •carcinomas, and carcinoma in situ of the cervix that
- •have been completely excised and considered cured >2
- •years prior to Screening.
- •- Significant cardiac disease (e.g., New York Heart
- •Association Class 3 or 4; myocardial
- •infarction within the past 6 months; unstable angina;
- •coronary angioplasty or coronary artery bypass graft
- •within the past 6 months; uncontrolled atrial or
- •ventricular cardiac arrhythmias; or pulmonary
- •hypertension requiring pharmacologic treatment).
- •- Clinical diagnosis of any connective tissue disease
- •(including but not limited to scleroderma,
- •polymyositis/dermatomyositis, systemic lupus
- •erythematosus, and rheumatoid arthritis) or a diagnosis
- •of interstitial pneumonia with autoimmune features as
- •determined by the Investigator.
- •- Other disease that may interfere with testing
- •procedures or, in the judgment of the Investigator, may
- •interfere with study participation or may put the patient
- •at risk when participating in this study.
- •- Other unspecified reasons that, in the opinion of the
- •Investigator or Biogen, make the subject unsuitable for
- •enrollment.
- •NOTE: Other protocol defined exclusion criteria may apply.
Investigators
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