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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01890265
Registration number
NCT01890265
Ethics application status
Date submitted
24/06/2013
Date registered
1/07/2013
Date last updated
4/09/2020
Titles & IDs
Public title
Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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FGCL-3019-067
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pamrevlumab
Treatment: Drugs - Placebo
Treatment: Drugs - Sub-Study: Pirfenidone
Treatment: Drugs - Sub-Study: Nintedanib
Experimental: Pamrevlumab - Participants will receive pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Placebo Comparator: Placebo - Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Active Comparator: Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib - Participants will receive pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg.
Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician.
Placebo Comparator: Sub-Study: Placebo+Pirfenidone or Nintedanib - Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg.
Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician.
Treatment: Drugs: Pamrevlumab
Solution for infusion
Treatment: Drugs: Placebo
Solution for infusion
Treatment: Drugs: Sub-Study: Pirfenidone
Pirfenidone concomitant therapy will not be provided by the Sponsor.
Treatment: Drugs: Sub-Study: Nintedanib
Nintedanib concomitant therapy will not be provided by the Sponsor.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48
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Assessment method [1]
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FVC in liters was measured during the spirometry assessments at screening and during the randomized treatment period at Day 1 and every 12 weeks. The FVC (% predicted) was calculated for the corresponding gender-race-age group. The least squares (LS) mean change from Baseline to Week 48 (end of the randomized treatment period) in FVC (% predicted) is presented. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Other statistical analysis data is reported in the statistical analysis section. Observed data from all visits were included in the model.
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Timepoint [1]
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Baseline (Screening and Day 1), Week 48
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Secondary outcome [1]
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Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48
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Assessment method [1]
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The extent of pulmonary fibrosis was measured by HRCT scans of the chest at screening and at Weeks 24 and 48, to determine the HRCT QLF score. Each lung was divided into 5 lobes (right upper, right middle, right lower, left upper, left lower). For the quantitative HRCT analyses, a computer read the images and quantified the percent (%) and volume (mL) of fibrosis for the whole lung by averaging the scores from each of 5 lung lobes. Baseline was defined as the Screening evaluation. Missing data were imputed using the multiple imputation (MI) method to handle missing values.
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Timepoint [1]
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Baseline (Screening), Week 24 and Week 48
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Secondary outcome [2]
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Number of Participants With IPF Progression Events up to Week 48
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Assessment method [2]
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IPF progression events included death from any cause or absolute decline in FVC (% predicted) value of =10%, confirmed by repeat spirometry. Classification of FVC (% predicted) declined =10% was based on observed and imputed data. Missing data in FVC (% predicted) were imputed using the predicted values from the random coefficient module with treatment, visit, visit-by-treatment interaction, and Baseline FVC (% predicted) as fixed effects and linear slope as random effect.
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Timepoint [2]
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Baseline (Screening and Day 1) up to Week 48
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Secondary outcome [3]
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Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48
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Assessment method [3]
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HRQoL was assessed by the SGRQ to measure health impairment, and includes 17 questions in 3 domains: Symptoms, Activity and Impacts. The domain and total scores range from 0 to 100, with 0 indicating the best and 100 indicating the worst possible health status. Missing data at post-baseline visits were imputed as the predicted values from the random coefficient model which included treatment, visit, visit-by-treatment interaction, and Baseline SGRQ score as fixed effects and linear slope of visit as random effect.
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Timepoint [3]
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Baseline (Day 1), Week 24 and Week 48
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Secondary outcome [4]
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Number of Participants With a Respiratory-Related Hospitalization
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Assessment method [4]
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Respiratory-related hospitalizations were reported by participants and recorded by the Investigators.
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Timepoint [4]
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Week 55
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Secondary outcome [5]
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Number of Participants With a Respiratory-Related Death
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Assessment method [5]
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Investigators determined whether a death was respiratory-related.
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Timepoint [5]
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Week 55
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Secondary outcome [6]
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Number of Participants With No Decline in FVC (% Predicted) at Week 48
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Assessment method [6]
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FVC in liters was measured during the spirometry assessments. The FVC (% predicted) was calculated for the corresponding gender-race-age group. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Classification of 'No decline' is based on observed and imputed data. Missing data in FVC (% predicted) are imputed using the predicted values from the random coefficient model with treatment, visit, visit-by-treatment interaction, and Baseline FVC (% predicted) as fixed effects and linear slope of visit as random effect.
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Timepoint [6]
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Baseline (Day 1) to Week 48.
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Eligibility
Key inclusion criteria
1. Age 40 to 80 years, inclusive.
2. Diagnosis of IPF as defined by current international guidelines. Each participant must
have 1 of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an
available high-resolution computed tomography (HRCT) scan; or (2) Possible UIP Pattern
on an available HRCT scan and surgical lung biopsy within 4 years of Screening showing
UIP Pattern.
3. History of IPF of =5 years duration with onset defined as the date of the first
diagnosis of IPF by HRCT or surgical lung biopsy.
4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of
=10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the
whole lung, as determined by the HRCT central reader.
5. FVC percent of predicted value =55% at Screening.
6. Female participants of childbearing potential (including those <1 year postmenopausal)
must be willing to use a medically acceptable method of contraception, for example, an
oral contraceptive, depot progesterone, or intrauterine device. Male participants with
female partners of childbearing potential who are not using birth control as described
above must use a barrier method of contraception (for example, condom) if not
surgically sterile (for example, vasectomy).
7. For sub-study only: Receiving treatment for IPF with a stable dose of pirfenidone or
with a stable dose of nintedanib for at least 3 months before Screening initiation and
willing to continue treatment with pirfenidone or with nintedanib according to the
corresponding approved label and the prescribing physician, including all listed
safety requirements (for example, liver function tests, avoidance of sunlight and
sunlamp exposure and wearing of sunscreen and protective clothing daily for
pirfenidone, and smoking cessation).
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Minimum age
40
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Women who are pregnant or nursing.
2. Infiltrative lung disease other than IPF, including any of the other types of
idiopathic interstitial pneumonias (Travis, 2013); lung diseases related to exposure
to fibrogenic agents or other environmental toxins or drugs; other types of
occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases;
systemic diseases, including vasculitis and connective tissue diseases.
3. HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by
the HRCT central reader.
4. Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as
determined by the local pathologist.
5. The Investigator judges that there has been sustained improvement in the severity of
IPF during the 12 months prior to Screening, based on changes in FVC, diffusing
capacity of the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest.
6. Clinically important abnormal laboratory tests.
7. Upper or lower respiratory tract infection of any type within 4 weeks of the first
Screening visit.
8. Acute exacerbation of IPF within 3 months of the first Screening visit.
9. Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal
antibodies were used, the last dose of the antibody must be at least 4 weeks before
Day 1 dosing. This applies to participants enrolled in Main Study only.
10. Use of any investigational drugs, including any investigational drugs for IPF, within
4 weeks prior to Day 1 dosing.
11. History of cancer diagnosis of any type in the 3 years preceding Screening, excluding
non-melanomatous skin cancer, localized bladder cancer, or in situ cancers.
12. Diffusing capacity (DLCO) less than 30% of predicted value.
13. History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine
monoclonal antibodies.
14. Previous treatment with FG-3019.
15. Body weight greater than 130 kilograms.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/11/2017
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Concord Repatriation - Concord
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Recruitment hospital [2]
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Daw Park Repatriation - Adelaide
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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5041 - Adelaide
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Recruitment outside Australia
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Alabama
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California
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Colorado
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Connecticut
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
FibroGen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the
efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the
progression of IPF in these participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01890265
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Trial related presentations / publications
Lipson KE, Wong C, Teng Y, Spong S. CTGF is a central mediator of tissue remodeling and fibrosis and its inhibition can reverse the process of fibrosis. Fibrogenesis Tissue Repair. 2012 Jun 6;5(Suppl 1):S24. doi: 10.1186/1755-1536-5-S1-S24. eCollection 2012.
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Public notes
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Contacts
Principal investigator
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Mark Wencel, M.D
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Address
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Via Christi Clinic, P.A., USA
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01890265
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