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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2016-003473-17
    Trial protocol
    		 GB   GR  
    Global end of trial date
    24 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2023
    First version publication date
    07 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CC-90001-IPF-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of CC-90001, 200 mg and 400 mg, when orally administered (PO) once daily (QD), compared with placebo, on percent of predicted forced vital capacity (FVC) after 24 weeks of treatment in subjects with idiopathic pulmonary fibrosis (IPF).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Turkey: 5
    Country: Number of subjects enrolled
    Ukraine: 23
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    United States: 20
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Colombia: 2
    Worldwide total number of subjects
    135
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    36
    From 65 to 84 years
    98
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants in the placebo arm during treatment period were re-randomized during the active treatment period to receive either CC-90001 200mg or CC-90001 400mg. 1 participant in the active treatment period did not have the end of study form filled out and therefore was listed in the missing row.

    Period 1
    Period 1 title
    Placebo Controlled Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CC-90001 200mg (IPF Study)
    Arm description
    		 CC-90001 200mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg PO QD (One 200mg tablet)

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one placebo tablet PO QD

    Arm title
    		 CC-90001 400mg (IPF Study)
    Arm description
    		 CC-90001 400mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg PO QD (Two 200mg tablet)

    Arm title
    		 Placebo (IPF Study)
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    two placebo tablets PO QD

    Arm title
    		 CC-90001 400mg (PPF Sub-Study)
    Arm description
    		 CC-90001 400mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg PO QD (Two 200mg tablet)

    Arm title
    		 Placebo (PPF Sub-Study)
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    two placebo tablets PO QD

    Number of subjects in period 1
    		CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Started
    39
    37
    36
    15
    8
    Completed
    32
    28
    31
    15
    7
    Not completed
    7
    9
    5
    0
    1
         Adverse event, serious fatal
    -
    1
    1
    -
    -
         Adverse event, non-fatal
    4
    5
    1
    -
    -
         Other Reasons
    1
    -
    -
    -
    -
         Progressive Disease
    1
    -
    1
    -
    -
         Withdrawal by participant
    1
    3
    2
    -
    1
    Period 2
    Period 2 title
    Active Treatment Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CC-90001 200mg (IPF Study)
    Arm description
    		 CC-90001 200mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-90001 and placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg of CC-90001 (One 200mg Tablet PO QD) and One placebo tablet

    Arm title
    		 CC-90001 400mg (IPF Study)
    Arm description
    		 CC-90001 400mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg (Two 200mg Tablet PO QD)

    Arm title
    		 Placebo (IPF Study)
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg (two 200mg Tablet PO QD)

    Investigational medicinal product name
    CC-90001 and placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg of CC-90001 (One 200mg Tablet PO QD) and One placebo tablet

    Arm title
    		 CC-90001 400mg (PPF Sub-Study)
    Arm description
    		 CC-90001 400mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg (Two 200mg Tablet PO QD)

    Arm title
    		 Placebo (PPF Sub-Study)
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    CC-90001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg (Two 200mg Tablet PO QD)

    Investigational medicinal product name
    CC-90001 and placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg of CC-90001 (One 200mg Tablet PO QD) and One placebo tablet

    Number of subjects in period 2 [1]
    		CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Started
    31
    27
    30
    15
    6
    CC-90001 200mg
    0 [2]
    0 [3]
    15
    0 [4]
    3
    CC-90001 400mg
    0 [5]
    0 [6]
    15
    0 [7]
    3
    Completed
    5
    13
    15
    3
    0
    Not completed
    26
    14
    15
    12
    6
         Adverse event, serious fatal
    2
    1
    1
    1
    -
         Physician decision
    2
    -
    -
    -
    -
         Adverse event, non-fatal
    6
    5
    4
    1
    -
         Other Reasons
    3
    3
    3
    8
    3
         Progressive Disease
    10
    5
    4
    1
    2
         Withdrawal by participant
    2
    -
    3
    1
    1
         Unknown, participant missing
    1
    -
    -
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Re-randomization occurred after placebo treatment phase going into active treatment extension treatment phase

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CC-90001 200mg (IPF Study)
    Reporting group description
    		 CC-90001 200mg PO QD

    Reporting group title
    CC-90001 400mg (IPF Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (IPF Study)
    Reporting group description
    		 Placebo

    Reporting group title
    CC-90001 400mg (PPF Sub-Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (PPF Sub-Study)
    Reporting group description
    		 Placebo

    Reporting group values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study) Total
    Number of subjects
    		 39 37 36 15 8 135
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0 0 0 0
        Between 18 and 65 years
    		 11 7 5 8 5 36
        >=65 years
    		 28 30 31 7 3 99
    Sex: Female, Male
    Units: Participants
        Female
    		 11 8 6 6 4 35
        Male
    		 28 29 30 9 4 100
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 1 1 1 0 0 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0
        White
    		 38 35 35 15 8 131
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 1 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 4 3 0 0 11
        Not Hispanic or Latino
    		 35 33 32 15 8 123
        Unknown or Not Reported
    		 0 0 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    CC-90001 200mg (IPF Study)
    Reporting group description
    		 CC-90001 200mg PO QD

    Reporting group title
    CC-90001 400mg (IPF Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (IPF Study)
    Reporting group description
    		 Placebo

    Reporting group title
    CC-90001 400mg (PPF Sub-Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (PPF Sub-Study)
    Reporting group description
    		 Placebo
    Reporting group title
    CC-90001 200mg (IPF Study)
    Reporting group description
    		 CC-90001 200mg PO QD

    Reporting group title
    CC-90001 400mg (IPF Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (IPF Study)
    Reporting group description
    		 Placebo

    Reporting group title
    CC-90001 400mg (PPF Sub-Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (PPF Sub-Study)
    Reporting group description
    		 Placebo

    Subject analysis set title
    Placebo/CC-90001 200mg (IPF Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase

    Subject analysis set title
    Placebo/CC-90001 400mg (IPF Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase

    Subject analysis set title
    Placebo/CC-90001 200mg (PPF Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase

    Subject analysis set title
    Placebo/CC-90001 400mg (PPF Sub-Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase

    Subject analysis set title
    Placebo/CC-90001 200mg (IPF Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase

    Subject analysis set title
    Placebo/CC-90001 400mg (PPF Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase

    Subject analysis set title
    Placebo/CC-90001 200mg (PPF Sub-Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase

    Primary: Percentage point difference in % predicted forced vital capacity (FVC).

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    End point title
    		 Percentage point difference in % predicted forced vital capacity (FVC). [1] [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    from baseline to week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis done for this endpoint
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study)
    Number of subjects analysed
    39
    37
    36
    Units: Percentage Point
    arithmetic mean (standard deviation)
        Week 1
    0.5 ± 3.04
    0.6 ± 2.87
    -0.9 ± 3.51
        Week 4
    0.3 ± 4.65
    1.7 ± 3.90
    -1.4 ± 3.75
        Week 8
    0.5 ± 5.70
    2.4 ± 3.98
    -1.7 ± 3.75
        Week 12
    -0.6 ± 4.83
    2.0 ± 3.70
    -2.5 ± 4.57
        Week 16
    -1.7 ± 5.55
    1.0 ± 5.27
    -2.0 ± 4.43
        Week 20
    -1.2 ± 3.92
    0.6 ± 4.55
    -2.7 ± 6.60
        Week 24
    -2.3 ± 4.96
    -0.5 ± 4.77
    -2.5 ± 4.85
    No statistical analyses for this end point

    Secondary: Mean change from baseline in absolute forced vital capacity (FVC).

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    End point title
    		 Mean change from baseline in absolute forced vital capacity (FVC). [3]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    from baseline to week 24
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study)
    Number of subjects analysed
    32
    29
    30
    Units: mL
        arithmetic mean (standard deviation)
    -74.9 ± 162.58
    -6.8 ± 170.39
    -88.3 ± 176.80
    No statistical analyses for this end point

    Secondary: Mean change from baseline in dyspnea rating on Borg Scale

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    End point title
    		 Mean change from baseline in dyspnea rating on Borg Scale [4]
    End point description
    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. Time points to be measured From baseline to Week 24, extension week 52, extension week 76, extension week 104, week 24 to extension week 52 and Week 24 to extension week 104 here "9999" signifies NA
    End point type
    Secondary
    End point timeframe
    From baseline to Week 108
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (IPF Study)
    Number of subjects analysed
    39
    37
    36
    15
    15
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 24
    0.4 ± 1.38
    0.1 ± 1.39
    0.0 ± 1.55
    9999 ± 9999
    9999 ± 9999
        Extension Week 52
    0.9 ± 1.32
    1.3 ± 1.48
    9999 ± 9999
    0.1 ± 0.68
    1.0 ± 1.93
        Extension Week 76
    -0.2 ± 1.53
    1.2 ± 1.30
    9999 ± 9999
    -0.7 ± 1.30
    -0.5 ± 1.52
        Extension Week 104
    1.0 ± 3.50
    0.6 ± 1.15
    9999 ± 9999
    1.3 ± 0.88
    -0.5 ± 1.52
        Week 24 to ext Week 52
    0.7 ± 1.71
    1.1 ± 1.53
    9999 ± 9999
    -0.1 ± 0.64
    1.5 ± 2.25
        Week 24 to ext Week 104
    1.8 ± 2.57
    -0.1 ± 1.02
    9999 ± 9999
    0.3 ± 0.52
    0.2 ± 2.25
    No statistical analyses for this end point

    Secondary: Percentage of participants who had disease progression

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    End point title
    		 Percentage of participants who had disease progression [5]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    From Baseline up to week 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study)
    Number of subjects analysed
    39
    37
    36
    Units: Percentage of participants
        number (not applicable)
    23.1
    27.0
    25.0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in total score and domains on the Saint George’s Respiratory Questionnaire (SGRQ)

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    End point title
    		 Mean change from baseline in total score and domains on the Saint George’s Respiratory Questionnaire (SGRQ) [6]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    From Baseline up to week 24
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study)
    Number of subjects analysed
    28
    23
    27
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Activity
    2.1 ± 16.95
    -6.5 ± 12.72
    -4.5 ± 13.04
        Impact of disease on daily life
    -1.9 ± 19.31
    -8.6 ± 19.17
    -1.2 ± 20.59
        Symptoms
    2.0 ± 21.10
    -11.8 ± 17.57
    -8.3 ± 20.63
        Total
    -0.3 ± 16.84
    -8.6 ± 15.44
    -3.7 ± 15.99
    No statistical analyses for this end point

    Secondary: Mean change from baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)

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    End point title
    		 Mean change from baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) [7]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    From Baseline up to week 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study)
    Number of subjects analysed
    26
    23
    27
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    1.1 ± 17.28
    -3.3 ± 16.69
    -1.4 ± 16.19
    No statistical analyses for this end point

    Secondary: Mean change in distance walked in the 6-minute Walk Test (6MWT)

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    End point title
    		 Mean change in distance walked in the 6-minute Walk Test (6MWT) [8]
    End point description
    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 week 52 and Week 24 to extension 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. Here "9999" signifies NA
    End point type
    Secondary
    End point timeframe
    From baseline up to week 104
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (IPF Study)
    Number of subjects analysed
    39
    37
    36
    15
    15
    Units: meters
    arithmetic mean (standard deviation)
        Week 24
    6.9 ± 73.42
    -21.1 ± 45.80
    -8.1 ± 49.89
    9999 ± 9999
    9999 ± 9999
        Extension Week 52
    -21.9 ± 82.57
    -15.9 ± 46.42
    9999 ± 9999
    -30.0 ± 56.69
    -29.1 ± 94.95
        Extension Week 76
    -9.7 ± 58.90
    3.7 ± 46.31
    9999 ± 9999
    14.4 ± 25.00
    -42.7 ± 92.46
        Extension Week 104
    -15.3 ± 95.13
    -25.4 ± 58.73
    9999 ± 9999
    -18.6 ± 56.24
    -38.7 ± 87.80
        Week 24 to ext Week 52
    0.2 ± 1.02
    0.7 ± 1.25
    9999 ± 9999
    -0.9 ± 0.88
    0.7 ± 1.59
        Week 24 to ext Week 104
    0.0 ± 1.00
    -0.3 ± 0.42
    9999 ± 9999
    0.6 ± 1.24
    -0.1 ± 1.66
    No statistical analyses for this end point

    Secondary: Number of participants with Adverse events at the end of the active treatment phase

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    End point title
    		 Number of participants with Adverse events at the end of the active treatment phase [9]
    End point description
    Number of participants with Adverse events at the end of the active treatment phase TEAE = Treatment emergent adverse event tx = treatment
    End point type
    Secondary
    End point timeframe
    From re-randomization to end of treatment (approximately 84 weeks)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (IPF Study) Placebo/CC-90001 200mg (PPF Sub-study) Placebo/CC-90001 400mg (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    15
    15
    15
    3
    3
    Units: Participants
        TEAE
    25
    23
    11
    11
    13
    2
    3
        TEAE related to study treatment
    7
    13
    1
    2
    8
    1
    0
        Serious TEAE
    10
    6
    2
    3
    4
    0
    0
        Serious TEAE related to study Drug
    0
    0
    0
    0
    0
    0
    0
        Severe TEAE
    8
    7
    2
    2
    4
    0
    0
        TEAE leading to Death
    5
    4
    1
    2
    2
    0
    0
        TEA leading to study treatment interruption
    2
    6
    1
    1
    2
    0
    0
        TEAE leading to permanent tx discontinuation
    6
    4
    1
    0
    3
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with Adverse events in the placebo controlled period

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    End point title
    		 Number of participants with Adverse events in the placebo controlled period
    End point description
    Number of participants with Adverse events in the placebo controlled period. TEAE = Treatment emergent adverse event tx = treatment
    End point type
    Secondary
    End point timeframe
    from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    36
    15
    8
    Units: Participants
        TEAE
    30
    34
    31
    8
    5
        TEAE related to study treatment
    14
    21
    14
    3
    1
        Serious TEAE
    6
    4
    2
    1
    0
        Serious TEAE related to study Drug
    1
    1
    0
    0
    0
        Severe TEAE
    4
    8
    3
    0
    0
        TEAE leading to Death
    0
    1
    2
    0
    0
        TEA leading to study treatment interruption
    6
    3
    5
    0
    2
        TEAE leading to permanent study tx discontinuation
    5
    7
    2
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with worst changes in hematology laboratory parameters during the active treatment extension period

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    End point title
    		 Number of participants with worst changes in hematology laboratory parameters during the active treatment extension period [10]
    End point description
    Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.
    End point type
    Secondary
    End point timeframe
    From re-randomization to end of treatment (approximately 84 weeks)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo/CC-90001 400mg (IPF Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (PPF Sub-study) Placebo/CC-90001 200mg (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    15
    15
    14
    3
    3
    Units: Participants
        Basophils - Normal to low
    0
    0
    0
    0
    0
    0
    0
        Basophils - Normal to high
    5
    3
    0
    1
    1
    0
    0
        Hemoglobin - Normal to low
    2
    2
    1
    0
    1
    0
    0
        Hemoglobin - Normal to high
    3
    4
    0
    1
    2
    0
    0
        Lymphocytes - Normal to low
    2
    2
    1
    1
    0
    0
    0
        Lymphocytes - Normal to high
    3
    5
    0
    1
    2
    1
    1
        Neutrophils - Normal to low
    1
    1
    0
    0
    0
    0
    0
        Neutrophils - Normal to high
    14
    11
    1
    6
    11
    0
    0
        Platelets - Normal to low
    0
    1
    0
    2
    0
    0
    0
        Platelets - Normal to high
    0
    1
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with worst changes in hematology laboratory parameters during the in the placebo controlled period

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    End point title
    		 Number of participants with worst changes in hematology laboratory parameters during the in the placebo controlled period
    End point description
    Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets. in the placebo controlled period
    End point type
    Secondary
    End point timeframe
    from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    36
    15
    8
    Units: Participants
        Basophils - Normal to low
    0
    0
    0
    0
    0
        Basophils - Normal to high
    3
    0
    1
    3
    2
        Hemoglobin - Normal to low
    4
    2
    1
    0
    0
        Hemoglobin - Normal to high
    2
    2
    3
    0
    0
        Lymphocytes - Normal to low
    1
    2
    2
    3
    0
        Lymphocytes - Normal to high
    4
    4
    2
    3
    1
        Neutrophils - Normal to low
    1
    0
    0
    1
    1
        Neutrophils - Normal to high
    6
    10
    7
    3
    2
        Platelets - Normal to low
    0
    1
    2
    0
    0
        Platelets - Normal to high
    4
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with a worst change from worst post-baseline in urinalysis laboratory analysis in the active treatment extension period

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    End point title
    		 Number of participants with a worst change from worst post-baseline in urinalysis laboratory analysis in the active treatment extension period [11]
    End point description
    Number of subjects with worst change from baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells Here "9999" signifies NA
    End point type
    Secondary
    End point timeframe
    From re-randomization to end of treatment (approximately 84 weeks)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (IPF Study) Placebo/CC-90001 400mg (PPF Sub-study) Placebo/CC-90001 200mg (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    15
    15
    15
    3
    3
    Units: Participants
        Erythrocytes - Normal to abnormal
    0
    0
    0
    0
    0
    1
    0
        Leukocytes - Normal to abnormal
    2
    1
    2
    0
    0
    1
    0
        Tubular Epithelial Cells - Normal abnormal
    9999
    9999
    9999
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Secondary: Number of participants with a worst change from worst post-baseline in urinalysis laboratory analysis in the placebo controlled period

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    End point title
    		 Number of participants with a worst change from worst post-baseline in urinalysis laboratory analysis in the placebo controlled period
    End point description
    Number of subjects with worst change from baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells Here "9999" signifies NA
    End point type
    Secondary
    End point timeframe
    from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    36
    15
    8
    Units: Participants
        Erythrocytes - Normal to Abnormal
    3
    0
    0
    1
    0
        Leukocytes - Normal to Abnormal
    4
    1
    2
    2
    0
        Tubular Epithelial Cells - Normal to Abnormal
    9999
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Electrocardiogram measurements in the active treatment extension period

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    End point title
    		 Mean change from baseline in Electrocardiogram measurements in the active treatment extension period [12]
    End point description
    Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
    End point type
    Secondary
    End point timeframe
    From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (IPF Study) Placebo/CC-90001 200mg (PPF Sub-study) Placebo/CC-90001 400mg (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    15
    15
    15
    3
    3
    Units: msec
    arithmetic mean (standard deviation)
        QT Interval
    -14.3 ± 29.70
    0.2 ± 23.85
    -3.0 ± 21.29
    -7.7 ± 22.23
    -10.9 ± 22.53
    9.0 ± 28.28
    25.0 ± 26.87
        QTcF Interval
    -3.9 ± 21.13
    2.2 ± 18.75
    5.6 ± 26.09
    -3.4 ± 15.02
    -1.9 ± 4.94
    14.0 ± 11.31
    23.5 ± 4.95
        QTcB Interval
    1.3 ± 21.06
    3.5 ± 25.53
    10.0 ± 37.36
    -0.7 ± 19.04
    2.9 ± 13.46
    17.5 ± 31.82
    22.5 ± 6.36
        PR Interval
    -9.2 ± 17.07
    9.2 ± 18.63
    0.6 ± 16.27
    -12.8 ± 6.55
    3.3 ± 15.27
    14.5 ± 28.99
    2.0 ± 7.07
        QRS Duration
    -1.8 ± 7.11
    5.1 ± 14.46
    2.1 ± 7.24
    1.0 ± 7.25
    -3.8 ± 5.60
    2.5 ± 2.12
    14.5 ± 13.44
        RR Interval
    -75.4 ± 129.46
    -14.0 ± 148.45
    -51.4 ± 167.76
    -25.7 ± 136.36
    -77.9 ± 181.66
    -28.0 ± 272.94
    15.5 ± 135.06
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Electrocardiogram measurements in the placebo controlled period

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    End point title
    		 Mean change from baseline in Electrocardiogram measurements in the placebo controlled period
    End point description
    Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
    End point type
    Secondary
    End point timeframe
    from baseline to week 24
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    36
    15
    8
    Units: msec
    arithmetic mean (standard deviation)
        QT Interval
    -2.9 ± 22.37
    0.2 ± 22.76
    -1.8 ± 26.23
    -9.6 ± 30.52
    -15.0 ± 15.56
        QTcF Interval
    -0.3 ± 15.12
    -0.9 ± 13.23
    -2.2 ± 16.80
    1.5 ± 16.83
    6.0 ± 1.41
        QTcB Interval
    0.5 ± 19.57
    -1.2 ± 16.57
    -2.4 ± 18.20
    7.6 ± 23.51
    19.0 ± 11.31
        PR Interval
    -5.1 ± 13.89
    -0.3 ± 10.84
    -0.8 ± 12.02
    -5.3 ± 12.23
    20.5 ± 20.51
        QRS Duration
    2.0 ± 8.86
    2.1 ± 9.65
    -0.5 ± 8.44
    -0.9 ± 6.74
    -3.0 ± 4.24
        RR Interval
    -20.9 ± 127.25
    6.5 ± 127.19
    13.0 ± 129.92
    -68.4 ± 173.55
    -110.5 ± 78.49
    No statistical analyses for this end point

    Secondary: Number of participants with worst increase from baseline in Blood Pressure in the active extension period

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    End point title
    		 Number of participants with worst increase from baseline in Blood Pressure in the active extension period [13]
    End point description
    Number of participants with an increase from baseline in systolic and diastolic blood pressure. Sys = systolic Dys = dyastolic inc = increase
    End point type
    Secondary
    End point timeframe
    From re-randomization to end of treatment (approximately 84 weeks)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Different reporting arms for different periods.
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo/CC-90001 200mg (IPF Study) Placebo/CC-90001 400mg (IPF Study) Placebo/CC-90001 200mg (PPF Sub-study) Placebo/CC-90001 400mg (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    15
    15
    15
    3
    3
    Units: Participants
        Sys inc from baseline > 10 but ≤ 15 (mild)
    5
    4
    1
    3
    1
    0
    0
        Sys inc from baseline > 15 but ≤ 20 (moderate)
    1
    4
    0
    2
    3
    0
    0
        Sys inc from baseline > 20 (severe)
    4
    8
    0
    4
    4
    0
    1
        Dys inc from baseline > 5 but ≤ 10 (mild)
    6
    6
    4
    7
    3
    1
    2
        Dys inc from baseline > 10 but ≤ 15 (moderate)
    5
    3
    1
    2
    4
    0
    0
        Dys inc from baseline > 15 (severe)
    5
    6
    0
    5
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with worst increase from baseline in Blood Pressure in the placebo-controlled period

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    End point title
    		 Number of participants with worst increase from baseline in Blood Pressure in the placebo-controlled period
    End point description
    Number of participants with worst increase from baseline in systolic and diastolic blood pressure. Sys = systolic Dys = dyastolic inc = increase
    End point type
    Secondary
    End point timeframe
    from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
    End point values
    		 CC-90001 200mg (IPF Study) CC-90001 400mg (IPF Study) Placebo (IPF Study) CC-90001 400mg (PPF Sub-Study) Placebo (PPF Sub-Study)
    Number of subjects analysed
    39
    37
    36
    0 [14]
    0 [15]
    Units: Participants
        Sys inc from baseline > 10 but ≤ 15 (mild)
    2
    0
    2
        Sys inc from baseline > 15 but ≤ 20 (moderate)
    3
    2
    3
        Sys inc from baseline > 20 (severe)
    0
    3
    0
        Sys inc from baseline > 5 but ≤ 10 (mild)
    4
    2
    1
        Dys inc from baseline > 10 but ≤ 15 (moderate)
    3
    2
    1
        Dys inc from baseline > 15 (severe)
    2
    2
    2
    Notes
    [14] - Not analyzed
    [15] - Not Analyzed
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events, Serious Adverse events and all cause mortality: approximately 108 weeks.
    Adverse event reporting additional description
    AEs, SAEs and All cause mortality are calculated from first dose, to 4 weeks after last treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    CC-90001 400 mg PO QD (IPF Study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    CC-90001 200 mg PO QD (IPF Study)
    Reporting group description
    		 CC-90001 200mg PO QD

    Reporting group title
    CC-90001 400 mg PO QD (PPF Sub-study)
    Reporting group description
    		 CC-90001 400mg PO QD

    Reporting group title
    Placebo (PPF Sub-study)
    Reporting group description
    		 Placebo

    Reporting group title
    Placebo (IPF Study)
    Reporting group description
    		 Placebo

    Serious adverse events
    		 CC-90001 400 mg PO QD (IPF Study) CC-90001 200 mg PO QD (IPF Study) CC-90001 400 mg PO QD (PPF Sub-study) Placebo (PPF Sub-study) Placebo (IPF Study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 37 (24.32%)
    16 / 39 (41.03%)
    3 / 15 (20.00%)
    0 / 8 (0.00%)
    9 / 36 (25.00%)
         number of deaths (all causes)
    5
    5
    1
    0
    6
         number of deaths resulting from adverse events
    Investigations
    Troponin increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Interstitial lung disease
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suspected COVID-19
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CC-90001 400 mg PO QD (IPF Study) CC-90001 200 mg PO QD (IPF Study) CC-90001 400 mg PO QD (PPF Sub-study) Placebo (PPF Sub-study) Placebo (IPF Study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 37 (86.49%)
    32 / 39 (82.05%)
    12 / 15 (80.00%)
    6 / 8 (75.00%)
    32 / 36 (88.89%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 39 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 37 (8.11%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    3
    4
    0
    0
    3
    Oedema peripheral
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    1
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    0
    0
    2
    Social circumstances
    Dependence on oxygen therapy
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 37 (18.92%)
    12 / 39 (30.77%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    12 / 36 (33.33%)
         occurrences all number
    10
    13
    0
    0
    16
    Dyspnoea
         subjects affected / exposed
    6 / 37 (16.22%)
    7 / 39 (17.95%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    6 / 36 (16.67%)
         occurrences all number
    6
    8
    0
    0
    8
    Dyspnoea exertional
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    1
    0
    0
    2
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 37 (0.00%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    3 / 8 (37.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    3
    0
    4
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    2
    0
    0
    1
    Productive cough
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    0
    0
    1
    Pulmonary hypertension
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Sinus congestion
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    1 / 15 (6.67%)
    2 / 8 (25.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    15
    3
    2
    Insomnia
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    1
    0
    0
    2
    Depression
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    1
    0
    0
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    0
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    3
    0
    0
    2
    Blood glucose increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    3
    0
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    2 / 15 (13.33%)
    4 / 8 (50.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    5
    6
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    6
    0
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Low density lipoprotein decreased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    3
    0
    0
    0
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    2
    0
    0
    1
    Fall
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    1
    0
    0
    2
    Limb injury
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    1
    0
    0
    2
    Rib fracture
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    0
    0
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    Atrial flutter
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 37 (16.22%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    4 / 36 (11.11%)
         occurrences all number
    7
    5
    0
    1
    4
    Dysgeusia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    7 / 37 (18.92%)
    3 / 39 (7.69%)
    3 / 15 (20.00%)
    3 / 8 (37.50%)
    4 / 36 (11.11%)
         occurrences all number
    17
    3
    25
    42
    5
    Paraesthesia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Neutrophilia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    0
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    0
    0
    3
    Abdominal discomfort
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    1
    0
    0
    7
    Abdominal pain
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 39 (2.56%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    3
    0
    1
    5
    Constipation
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    1
    0
    0
    0
    3
    Diarrhoea
         subjects affected / exposed
    11 / 37 (29.73%)
    10 / 39 (25.64%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    10 / 36 (27.78%)
         occurrences all number
    19
    14
    0
    0
    17
    Dyspepsia
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    5 / 36 (13.89%)
         occurrences all number
    2
    2
    0
    0
    7
    Flatulence
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    4 / 36 (11.11%)
         occurrences all number
    2
    3
    0
    0
    4
    Nausea
         subjects affected / exposed
    16 / 37 (43.24%)
    12 / 39 (30.77%)
    4 / 15 (26.67%)
    1 / 8 (12.50%)
    11 / 36 (30.56%)
         occurrences all number
    26
    16
    22
    3
    19
    Toothache
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    0
    1
    Vomiting
         subjects affected / exposed
    7 / 37 (18.92%)
    6 / 39 (15.38%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    13
    8
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    4
    0
    0
    0
    2
    Rash
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    4 / 36 (11.11%)
         occurrences all number
    3
    1
    0
    0
    7
    Skin exfoliation
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    3
    Rash pruritic
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    Urticaria
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    0
    0
    2
    Pollakiuria
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    0
    0
    0
    2
    Renal cyst
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal pain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 37 (13.51%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
    1 / 36 (2.78%)
         occurrences all number
    5
    0
    3
    5
    1
    Back pain
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 39 (2.56%)
    1 / 15 (6.67%)
    2 / 8 (25.00%)
    4 / 36 (11.11%)
         occurrences all number
    3
    1
    1
    22
    4
    Bursitis
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    4 / 37 (10.81%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    5
    1
    0
    0
    2
    Myalgia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    0
    0
    2
    Neck pain
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 39 (0.00%)
    2 / 15 (13.33%)
    2 / 8 (25.00%)
    2 / 36 (5.56%)
         occurrences all number
    4
    0
    3
    3
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 39 (0.00%)
    3 / 15 (20.00%)
    2 / 8 (25.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    3
    2
    1
    Bronchitis
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    3
    0
    0
    2
    Cystitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    2 / 8 (25.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Herpes zoster
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    0
    1
    1
    Influenza
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    0
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 37 (2.70%)
    4 / 39 (10.26%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    5 / 36 (13.89%)
         occurrences all number
    2
    10
    0
    0
    7
    Nasopharyngitis
         subjects affected / exposed
    5 / 37 (13.51%)
    3 / 39 (7.69%)
    1 / 15 (6.67%)
    3 / 8 (37.50%)
    5 / 36 (13.89%)
         occurrences all number
    6
    4
    1
    5
    5
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    2 / 15 (13.33%)
    1 / 8 (12.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    2
    1
    1
    Pyelonephritis acute
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    2
    2
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 37 (0.00%)
    3 / 39 (7.69%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    4
    0
    0
    2
    Rhinitis
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    0
    0
    2
    Sialoadenitis
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    Suspected COVID-19
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 37 (10.81%)
    5 / 39 (12.82%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    7
    9
    0
    0
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 37 (2.70%)
    4 / 39 (10.26%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    6
    0
    0
    3
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    5 / 36 (13.89%)
         occurrences all number
    1
    2
    0
    0
    5
    Gout
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 39 (2.56%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 39 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2017
    Added new inclusion criterion #4 regarding consideration of treatment options for idiopathic pulmonary fibrosis (IPF)  Revised inclusion criterion #6 regarding the diagnosis of IPF via high resolution computerized tomography (HRCT) Increased the time prior to randomization for acceptance of historical HRCT from  Revised inclusion criterion #11 and Protocol Summary regarding the lower limit for diffusion capacity of the lung for carbon monoxide (DLCO) In response to recommendations of investigators, the lower limit for hemoglobincorrected percent predicted DLCO was changed from ≥30% to ≥ 25%.  Revised exclusion criterion #9 regarding respiratory disorder Added to the term pulmonary arterial hypertension, requiring treatment to exclude those patients with more advanced disease.  Revised exclusion criterion #12 regarding IPF targeted therapies Mycophenolate mofetil was added to the list of excluded medications as it may be used off-label to treat IPF.  Included External Data Monitoring Committee (DMC) (Section 9.9.3 and Protocol Summary)  Revised Acute Exacerbation Criteria  Mandatory Discontinuation Due to Unsuccessful Treatment of Acute Exacerbation
    18 Jul 2018
    The rationale for the following changes is to allow idiopathic pulmonary fibrosis (IPF) subjects who were randomized to placebo the opportunity to receive CC-90001 (200 mg or 400 mg orally [PO] once a day [QD]) after 24 weeks of treatment. In the current study design, these subjects are not given the opportunity to receive CC-90001. It will also afford all subjects to receive active treatment for an additional 52 weeks (80-week Active Treatment Extension Phase).
    28 Aug 2019
    The primary purpose of this amendment is to allow subjects with idiopathic pulmonary fibrosis (IPF) receiving protocol-allowable standard of care (SOC) treatment to be enrolled in the study. Consequently, the number of subjects planned for enrollment was increased from 135 to 165 to obtain an adequate number of subjects receiving SOC. Another significant change incorporated into this amendment is the exclusion of nintedanib as an SOC treatment option, which was initially communicated to all sites as an Administrative Investigator Letter globally on 26 Sep 2018, based on results from a drug-drug interaction (DDI) study. A separate, exploratory substudy in subjects with progressive pulmonary fibrosis (PPF) will be initiated after a decision from an interim analysis allows continuation of the IPF study as planned. Approximately 45 qualifying PPF subjects would be enrolled into the substudy. As a result, the total number of randomized subjects into the entire study would increase from 165 to approximately 210 subjects.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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