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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/NCT03142191
Registration number
NCT03142191
Ethics application status
Date submitted
24/04/2017
Date registered
5/05/2017
Date last updated
28/06/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
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Scientific title
A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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2016-003473-17
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Secondary ID [2]
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CC-90001-IPF-001
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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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Fibrosis
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Idiopathic Interstitial Pneumonias
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Pathologic Processes
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Lung Diseases, Interstitial
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Lung Diseases
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Respiratory Tract Diseases
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Condition category
Condition code
Respiratory
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0
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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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0
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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 - CC-90001
Other interventions - Placebo
Experimental: CC-90001 400 mg PO QD - 55 subjects will be randomized to CC-90001 400mg
Experimental: CC-90001 200 mg PO QD - 55 subjects will be randomized to CC-90001 200mg
Placebo Comparator: Placebo PO QD - 55 subjects will be randomized to placebo
Experimental: CC-90001 400 mg PO QD- Sub-Study - 30 subjects will be randomized to CC-90001 400mg
Placebo Comparator: Placebo PO QD- Sub-Study - 15 subjects will be randomized to placebo
Treatment: Drugs: CC-90001
CC-90001 is a potent, selective inhibitor of JNK.
Other interventions: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Percentage Point Difference in % Predicted Forced Vital Capacity (FVC).
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Assessment method [1]
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Mean change from baseline in percentage point difference in % predicted forced vital capacity (FVC)
FAS population is defined as all randomized participants who received at least one dose of the investigational product.
Baseline is defined as day 1 of treatment.
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Timepoint [1]
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from baseline to week 24
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Secondary outcome [1]
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Mean Change From Baseline in Absolute Forced Vital Capacity (FVC).
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Assessment method [1]
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Mean change from baseline in absolute FVC in the full analysis set (FAS) population.
FAS population is defined as all randomized participants who received at least one dose of the investigational product.
Baseline is defined as day 1 of treatment.
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Timepoint [1]
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from baseline to week 24
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Secondary outcome [2]
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Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
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Assessment method [2]
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Mean change in distance walked in the 6-minute Walk Test (6MWT)
The 6MWT measures the distance a participant is able to walk on a hard, flat surface, over a total of six minutes.
The time points which will be measured are from baseline to Week 24, Extension Week 52, Extension Week 76, Extension Week 104, Week 24 to extension (Ext) Week 52 and Week 24 to Ext Week 104
FAS population is defined as all randomized participants who received at least one dose of the investigational product.
Baseline is defined as day 1 of treatment. Week 24 is the start of baseline of the active treatment extension period.
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Timepoint [2]
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From baseline up to week 104
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Secondary outcome [3]
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Mean Change From Baseline in Dyspnea Rating on Borg Scale
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Assessment method [3]
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Mean change from baseline in dyspnea rating on Borg Scale after the 6MWT.
The Borg scale ranges from 0 to 10. Where 0 is no dyspnea and a 10 is extremely strong dyspnea. The lower the number the better.
The time points which will be measured are from baseline to Week 24, Extension Week 52, Extension Week 76, Extension Week 104, Week 24 to extension (Ext) Week 52 and Week 24 to Ext Week 104
FAS population is defined as all randomized participants who received at least one dose of the investigational product.
Baseline is defined as day 1 of treatment. Week 24 is the start of baseline of the active treatment extension period.
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Timepoint [3]
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From baseline up to week 104
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Secondary outcome [4]
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Percentage of Participants Who Had Disease Progression
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Assessment method [4]
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Disease progression is defined as one or more of the following:
Death from respiratory failure,
Absolute decrease of = 10% from baseline in % predicted FVC at two consecutive evaluations at a minimum of 4 weeks between evaluations
Decrease from baseline of = 50 meters in 6MWT distance (in the absence of a readily explainable cause, such as injury or trauma).
Unexplained worsening hypoxemia (an absolute decrease from baseline of 4% or more in arterial oxygen saturation by pulse oximetry [SpO2]).
FAS population is defined as all randomized participants who received at least one dose of the investigational product.
Baseline is defined as day 1 of treatment.
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Timepoint [4]
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0
From Baseline up to week 24
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Secondary outcome [5]
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Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ)
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Assessment method [5]
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The SGRQ is a quality of life health questionnaire that has been validated in IPF. It consists of 76 items in three domains:
Symptoms
Activity
Impact of disease on daily life
A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment). In addition to the total score, there is also a score for each domain: symptoms, activity, and impact which are scored 0-100. Each component score is derived by dividing the summed weights, unique for all questions, by the maximum possible weight.
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Timepoint [5]
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From Baseline up to week 24
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Secondary outcome [6]
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Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)
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Assessment method [6]
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The UCSD-SOBQ is a 24-item dyspnea questionnaire that asks participants to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness") in two areas: 1) how short of breath they are while performing various activities (21 items); and 2) how much shortness of breath, fear of hurting themselves by overexerting, and fear of shortness of breath limit them in their daily lives (3 items). If the subject does not routinely perform the activity, they are asked to estimate the degree of shortness of breath anticipated. The UCSD-SOBQ is scored by summing responses across all 24 items to form a total score. Scores range from 0 to 120. The lower the score the better.
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Timepoint [6]
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From Baseline up to week 24
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Secondary outcome [7]
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Number of Participants With Adverse Events at the End of the Active Treatment Phase
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Assessment method [7]
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Number of participants with Adverse events at the end of the active treatment phase
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Timepoint [7]
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From re-randomization to end of treatment (approximately 84 weeks)
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Secondary outcome [8]
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Number of Participants With Adverse Events in the Placebo Controlled Period
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Assessment method [8]
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Number of participants with Adverse events
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Timepoint [8]
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from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
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Secondary outcome [9]
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Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period
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Assessment method [9]
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Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.
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Timepoint [9]
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From re-randomization to end of treatment (approximately 84 weeks)
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Secondary outcome [10]
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Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period
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Assessment method [10]
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Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.
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Timepoint [10]
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from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
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Secondary outcome [11]
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Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period
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Assessment method [11]
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Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures:
Erythrocytes, Leukocytes, Tubular Epithelial Cells
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Timepoint [11]
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From re-randomization to end of treatment (approximately 84 weeks)
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Secondary outcome [12]
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Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period
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Assessment method [12]
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Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures:
Erythrocytes, Leukocytes, Tubular Epithelial Cells
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Timepoint [12]
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from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
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Secondary outcome [13]
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Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period
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Assessment method [13]
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Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
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Timepoint [13]
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From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
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Secondary outcome [14]
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Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period
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Assessment method [14]
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Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
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Timepoint [14]
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from baseline to week 24
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Secondary outcome [15]
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Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period
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Assessment method [15]
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Number of participants with worst increase from baseline in systolic and diastolic blood pressure.
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Timepoint [15]
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From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
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Secondary outcome [16]
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Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period
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Assessment method [16]
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Number of participants with worst increase from baseline in systolic and diastolic blood pressure.
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Timepoint [16]
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from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
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Eligibility
Key inclusion criteria
Subject understands and has voluntarily signed and dated an informed consent form
1. Subject is male or female = 40 years of age
2. Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy
[SLB] or cryobiopsy) if available according to guidelines.
3. No features supporting an alternative diagnosis on transbronchial biopsy,
bronchoalveolar lavage (BAL), or SLB, if performed.
4. Percent predicted forced vital capacity (% FVC) = 45% and = 95% at Screening
5. Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) = 25% and
= 90% predicted at Screening.
6. Able to walk = 150 meters during the 6-minute walk test (6MWT) at Screening
7. Females of childbearing potential (FCBP) must commit to true abstinence or agree to
use two effective birth control methods.
8. Male subjects must practice true abstinence or use a barrier method of contraception.
9. Additional inclusion criteria apply.
Progressive Pulmonary Fibrosis (PPF) Sub-Study:
1. Met all inclusion criteria described for IPF subjects other than Inclusion Criterion
5.
2. Features of diffuse fibrosing lung disease of > 10% on HRCT by central reading.
3. Investigator-documented = 5% annualized relative decline in FVC in past 24 months from
Screening Visit 1
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Minimum age
40
Years
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Maximum age
No limit
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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
The presence of any of the following will exclude a subject from enrollment:
1. Subject has any significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study.
2. Subject with a QTcF > 450 msec.
3. Evidence of clinically relevant airways obstruction at Screening.
4. Subjects using therapy targeted to treat IPF.
5. History of latent or active TB, unless there is medical record documentation of
successful completion of a standard course of treatment
6. History of hepatitis B and/or hepatitis C, including those considered successfully
treated/cured
7. Pregnancy or lactation.
8. Additional exclusion criteria apply.
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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
Terminated
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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
26/07/2017
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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
24/12/2021
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Sample size
Target
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Accrual to date
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Final
138
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 608 - Camperdown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [4]
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Mater Medical Centre - South Brisbane
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Recruitment hospital [5]
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Local Institution - 601 - Adelaide
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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Local Institution - 605 - Parkville
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Recruitment hospital [9]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [10]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [11]
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Institute for Respiratory Health Inc - Nedlands
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Recruitment hospital [12]
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St Vincent Hospital - Sydney - Darlinghurst
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment postcode(s) [9]
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2010 - Darlinghurst
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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Texas
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Utah
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Vermont
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Brazil
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Goiás
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Brazil
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Rio Grande Do Sul
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Canada
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British Columbia
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Canada
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Ontario
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Cali
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Germany
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Berlin
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Germany
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Essen
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Germany
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Giessen
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Germany
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Heidelberg
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Germany
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Wangen Im Allgaeu
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Greece
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Alexandroupolis
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Haidari
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Heraklion
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Iraklio
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Romania
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Cluj-Napoca
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Romania
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Timisoara
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Russian Federation
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Ekaterinburg
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Russian Federation
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Izhevsk
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Russian Federation
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Kemerovo
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Krasnoyarsk
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Petrozavodsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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Taiwan
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Dalin
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taipei, Zhongzheng Dist.
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Turkey
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Bornova
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Turkey
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Bursa
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Turkey
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Istanbul
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Izmir
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Ukraine
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Dnipro
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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United Kingdom
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Birmingham
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Cottingham
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Huntingdon
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Leeds
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Leicester
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Liverpool (Walton Centre)
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United Kingdom
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Llandough
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United Kingdom
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London
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United Kingdom
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Newcastle
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United Kingdom
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Norwich
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United Kingdom
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Nottingham
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United Kingdom
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Salford
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United Kingdom
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Southhampton
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United Kingdom
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Westbury-on-Trym/ Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Summary
Brief summary
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled
study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory
pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with
placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis
(IPF). This study is designed to assess response to treatment by using measures of lung
function, disease progression, fibrosis on radiography, and patient-reported outcomes. It
will also assess dose response.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03142191
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03142191
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