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

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2017-003158-18-ES
• Date of registration: 05/06/2018
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: 27/07/2018
• Target sample size: 290
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003158-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Biogen España
• Affiliation: Biogen Idec Research Limited

• Name: Biogen España
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Not yet assigned
Current Sponsor code: BG00011
Other descriptive name: BG00011
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 56-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To evaluate
-The efficacy of BG00011 compared with placebo in subjects with IPF as determined by change in percent predicted FVC
-The safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011
To assess in subjects who receive BG00011 compared with placebo:
-Progression-free survival.
-The occurrence of IPF exacerbation.
-The incidence of absolute decline in FVC =10% .
-The time to death or lung transplantation, and the transplant-free survival rate at Week 26 and Week 52.
-The time to nonselective hospitalizations.
-Additional PFT findings.
- Performance on the 6MWT.
Please refer to protocol for further secondary objectives

Timepoint(s) of evaluation of this end point: Various time point assessments throughout the study

Primary end point(s): Yearly Rate of Change in Forced (Expiratory) Vital Capacity (FVC)

Main Objective: To evaluate the efficacy of BG00011 compared with placebo in subjects with Idiopathic pulmonary fibrosis (IPF).

Secondary Outcome(s)

Secondary end point(s): - Percent Predicted Yearly Rate of Change in FVC
- Time to Progression
- Time to First Acute Exacerbation
- Percentage of Participants with at least 1 Acute Exacerbation
- Number of Exacerbations
- Number of Participants with Absolute Decline of 10% Predicted in FVC
- Time to Death or Lung Transplantation
- Time to All Non-Elective Hospitalizations
- Time to All Non-Elective Respiratory Hospitalizations
- Change from Baseline in Absolute Predicted FVC
- Change from Baseline in Percent Predicted FVC
- Change from Baseline in Absolute Predicted Carbon Monoxide Diffusion Capacity (DLco)
- Change from Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
- Change from Baseline in Absolute Predicted Total Lung Capacity
- Change from Baseline in Percent Predicted Total Lung Capacity
- Change from Baseline in 6 Minute Walk Test (6MWT) Parameters
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Percentage of Participants With Anti-BG00011 Antibodies in the Serum
- Concentration of BG00011 in the Serum

Timepoint(s) of evaluation of this end point: Change to baseline, weeks 26 and 52

Secondary ID(s)

203PF203

Source(s) of Monetary Support

Biogen Idec Research Limited