Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis

Phase 1

• Conditions: mild to moderate Idiopathic Pulmonary Fibrosis; MedDRA version: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-003158-18-ES
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-05
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 290

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:
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
rest).
- 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
scans.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified