Fibrosis, Idiopathic Interstitial Pneumonias, Idiopathic Pulmonary Fibrosis, Lung Diseases, Lung Diseases, Interstitial, Pathologic Processes, Respiratory Tract Diseases
Conditions
Keywords
Idiopathic Pulmonary Fibrosis (IPF), Pulmonary Fibrosis, CC-90001, Safety, Efficacy, IPF, idiopathic pulmonary fibrosis
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.
Detailed description
Approximately 165 adult male and female subjects with a confirmed diagnosis of Idiopathic pulmonary fibrosis (IPF) (according to the most recent IPF guideline for diagnosis and management) will be randomized 1:1:1 (55 subjects per arm) to treatment with oral CC-90001or matching placebo for an initial 24 weeks. The randomization will be stratified based on the concurrent administration of SOC (Yes/No). Subjects completing the 24-week Double-blind Treatment Phase will continue onto the 80-week Active Treatment Extension Phase. At Week 24, all subjects originally randomized to receive placebo will be re-randomized 1:1 to blinded CC-90001 (200 mg or 400 mg PO QD). During the 80-week Active Treatment Extension Phase, all subjects not on concurrent SOC therapy will have the opportunity, if deemed appropriate by the Investigator, to receive allowed standard of care (SOC). The exploratory Progressive Pulmonary Fibrosis (PPF) sub study will evaluate the efficacy, safety, PK, quality of life and exploratory PD of one PO treatment dose regimen of CC-90001, compared with placebo, for an initial 24 weeks of treatment, in subjects with PPF and long-term safety in the 80-week Active Treatment Extension Phase when all PPF subjects will receive CC-90001. Approximately 45 non-SOC subjects will be randomized in this sub study. All subjects who complete the study treatment phases and those subjects who discontinue investigational product (IP) prior to the completion of the study will participate in the 4-week Post-treatment Observational Follow-up Phase. The study will be conducted in compliance with the International Council Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. An external DMC, comprised of independent physician experts and a statistician who are not affiliated with the Sponsor and for whom there is no identified conflict of interest will be responsible for safeguarding study participants' interests and for monitoring the overall conduct of the study.
Interventions
DRUGCC-90001
CC-90001 is a potent, selective inhibitor of JNK.
OTHERPlacebo
Placebo
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | from baseline to week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | From baseline up to week 104 | 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. |
| Mean Change From Baseline in Dyspnea Rating on Borg Scale | From baseline up to week 104 | 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. |
| Percentage of Participants Who Had Disease Progression | From Baseline up to week 24 | 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. |
| Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | From Baseline up to week 24 | 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. |
| Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) | From Baseline up to week 24 | 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. |
| Number of Participants With Adverse Events at the End of the Active Treatment Phase | From re-randomization to end of treatment (approximately 84 weeks) | Number of participants with Adverse events at the end of the active treatment phase |
| Number of Participants With Adverse Events in the Placebo Controlled Period | from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort) | Number of participants with Adverse events |
| Mean Change From Baseline in Absolute Forced Vital Capacity (FVC). | from baseline to week 24 | 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. |
| Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort) | Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets. |
| Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | From re-randomization to end of treatment (approximately 84 weeks) | Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells |
| Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort) | Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells |
| Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks) | Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval |
| Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | from baseline to week 24 | Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval |
| Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks) | Number of participants with worst increase from baseline in systolic and diastolic blood pressure. |
| Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort) | Number of participants with worst increase from baseline in systolic and diastolic blood pressure. |
| Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | From re-randomization to end of treatment (approximately 84 weeks) | Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets. |
Countries
Australia, Brazil, Canada, Colombia, Germany, Greece, Romania, Russia, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Pre-assignment 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.
Participants by arm
| Arm | Count |
|---|---|
| CC-90001 200mg (IPF Study) CC-90001 200mg PO QD | 39 |
| CC-90001 400mg (IPF Study) CC-90001 400mg PO QD | 37 |
| Placebo (IPF Study) Placebo | 36 |
| CC-90001 400mg (PPF Sub-Study) CC-90001 400mg PO QD | 15 |
| Placebo (PPF Sub-Study) Placebo | 8 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Active Treatment Extension Period | Adverse Event | 6 | 5 | 4 | 1 | 0 |
| Active Treatment Extension Period | Death | 2 | 1 | 1 | 1 | 0 |
| Active Treatment Extension Period | Other Reasons | 3 | 3 | 3 | 8 | 3 |
| Active Treatment Extension Period | Physician Decision | 2 | 0 | 0 | 0 | 0 |
| Active Treatment Extension Period | Progressive Disease | 10 | 5 | 4 | 1 | 2 |
| Active Treatment Extension Period | Unknown, participant missing | 1 | 0 | 0 | 0 | 0 |
| Active Treatment Extension Period | Withdrawal by participant | 2 | 0 | 3 | 1 | 1 |
| Placebo Controlled Period | Adverse Event | 4 | 5 | 1 | 0 | 0 |
| Placebo Controlled Period | Death | 0 | 1 | 1 | 0 | 0 |
| Placebo Controlled Period | Other Reasons | 1 | 0 | 0 | 0 | 0 |
| Placebo Controlled Period | Progressive Disease | 1 | 0 | 1 | 0 | 0 |
| Placebo Controlled Period | Withdrawal by participant | 1 | 3 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | CC-90001 200mg (IPF Study) | CC-90001 400mg (IPF Study) | Placebo (IPF Study) | CC-90001 400mg (PPF Sub-Study) | Placebo (PPF Sub-Study) | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 30 Participants | 31 Participants | 7 Participants | 3 Participants | 99 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 7 Participants | 5 Participants | 8 Participants | 5 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 33 Participants | 32 Participants | 15 Participants | 8 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 38 Participants | 35 Participants | 35 Participants | 15 Participants | 8 Participants | 131 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 6 Participants | 6 Participants | 4 Participants | 35 Participants |
| Sex: Female, Male Male | 28 Participants | 29 Participants | 30 Participants | 9 Participants | 4 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 39 | 5 / 37 | 2 / 36 | 2 / 15 | 2 / 15 | 1 / 15 | 0 / 8 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 32 / 39 | 33 / 37 | 31 / 36 | 10 / 15 | 13 / 15 | 12 / 15 | 1 / 8 | 2 / 3 | 3 / 3 |
| serious Total, serious adverse events | 16 / 39 | 9 / 37 | 2 / 36 | 3 / 15 | 4 / 15 | 3 / 15 | 0 / 8 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC).
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.
Time frame: from baseline to week 24
Population: Full Analysis Set in IPF Cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 4 | 0.3 Percentage Point | Standard Deviation 4.65 |
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 16 | -1.7 Percentage Point | Standard Deviation 5.55 |
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 12 | -0.6 Percentage Point | Standard Deviation 4.83 |
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 1 | 0.5 Percentage Point | Standard Deviation 3.04 |
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 24 | -2.3 Percentage Point | Standard Deviation 4.96 |
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 20 | -1.2 Percentage Point | Standard Deviation 3.92 |
| CC-90001 200mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 8 | 0.5 Percentage Point | Standard Deviation 5.7 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 12 | 2.0 Percentage Point | Standard Deviation 3.7 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 1 | 0.6 Percentage Point | Standard Deviation 2.87 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 4 | 1.7 Percentage Point | Standard Deviation 3.9 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 8 | 2.4 Percentage Point | Standard Deviation 3.98 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 16 | 1.0 Percentage Point | Standard Deviation 5.27 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 20 | 0.6 Percentage Point | Standard Deviation 4.55 |
| CC-90001 400mg (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 24 | -0.5 Percentage Point | Standard Deviation 4.77 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 16 | -2.0 Percentage Point | Standard Deviation 4.43 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 4 | -1.4 Percentage Point | Standard Deviation 3.75 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 24 | -2.5 Percentage Point | Standard Deviation 4.85 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 20 | -2.7 Percentage Point | Standard Deviation 6.6 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 12 | -2.5 Percentage Point | Standard Deviation 4.57 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 8 | -1.7 Percentage Point | Standard Deviation 3.75 |
| Placebo (IPF Study) | Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). | Week 1 | -0.9 Percentage Point | Standard Deviation 3.51 |
Secondary
Mean Change From Baseline in Absolute Forced Vital Capacity (FVC).
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.
Time frame: from baseline to week 24
Population: Full Analysis Set participants with evaluable measures in IPF cohort at week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Absolute Forced Vital Capacity (FVC). | -74.9 mL | Standard Deviation 162.58 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Absolute Forced Vital Capacity (FVC). | -6.8 mL | Standard Deviation 170.39 |
| Placebo (IPF Study) | Mean Change From Baseline in Absolute Forced Vital Capacity (FVC). | -88.3 mL | Standard Deviation 176.8 |
Secondary
Mean Change From Baseline in Dyspnea Rating on Borg Scale
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.
Time frame: From baseline up to week 104
Population: Full Analysis Set in the IPF cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 104 | 1.0 Score on a Scale | Standard Deviation 3.5 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 52 | 0.9 Score on a Scale | Standard Deviation 1.32 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 | 0.4 Score on a Scale | Standard Deviation 1.38 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 52 | 0.7 Score on a Scale | Standard Deviation 1.71 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 76 | -0.2 Score on a Scale | Standard Deviation 1.53 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 104 | 1.8 Score on a Scale | Standard Deviation 2.57 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 52 | 1.1 Score on a Scale | Standard Deviation 1.53 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 | 0.1 Score on a Scale | Standard Deviation 1.39 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 52 | 1.3 Score on a Scale | Standard Deviation 1.48 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 104 | 0.6 Score on a Scale | Standard Deviation 1.15 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 104 | -0.1 Score on a Scale | Standard Deviation 1.02 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 76 | 1.2 Score on a Scale | Standard Deviation 1.3 |
| Placebo (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 | 0.0 Score on a Scale | Standard Deviation 1.55 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 76 | -0.7 Score on a Scale | Standard Deviation 1.3 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 52 | -0.1 Score on a Scale | Standard Deviation 0.64 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 104 | 0.3 Score on a Scale | Standard Deviation 0.52 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 52 | 0.1 Score on a Scale | Standard Deviation 0.68 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 104 | 1.3 Score on a Scale | Standard Deviation 0.88 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 52 | 1.5 Score on a Scale | Standard Deviation 2.25 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 52 | 1.0 Score on a Scale | Standard Deviation 1.93 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 76 | -0.5 Score on a Scale | Standard Deviation 1.52 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Extension Week 104 | -0.5 Score on a Scale | Standard Deviation 1.52 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Dyspnea Rating on Borg Scale | Week 24 to Ext Week 104 | 0.2 Score on a Scale | Standard Deviation 2.25 |
Secondary
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period
Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
Time frame: From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
Population: Re-Randomized Safety Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | 1.3 msec | Standard Deviation 21.06 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | -3.9 msec | Standard Deviation 21.13 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | -1.8 msec | Standard Deviation 7.11 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | -9.2 msec | Standard Deviation 17.07 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | -14.3 msec | Standard Deviation 29.7 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | -75.4 msec | Standard Deviation 129.46 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | -14.0 msec | Standard Deviation 148.45 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | 3.5 msec | Standard Deviation 25.53 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | 5.1 msec | Standard Deviation 14.46 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | 0.2 msec | Standard Deviation 23.85 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | 2.2 msec | Standard Deviation 18.75 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | 9.2 msec | Standard Deviation 18.63 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | -12.8 msec | Standard Deviation 6.55 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | -7.7 msec | Standard Deviation 22.23 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | -0.7 msec | Standard Deviation 19.04 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | -25.7 msec | Standard Deviation 136.36 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | -3.4 msec | Standard Deviation 15.02 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | 1.0 msec | Standard Deviation 7.25 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | -1.9 msec | Standard Deviation 4.94 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | -10.9 msec | Standard Deviation 22.53 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | 3.3 msec | Standard Deviation 15.27 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | -3.8 msec | Standard Deviation 5.6 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | -77.9 msec | Standard Deviation 181.66 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | 2.9 msec | Standard Deviation 13.46 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | 0.6 msec | Standard Deviation 16.27 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | -51.4 msec | Standard Deviation 167.76 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | 10.0 msec | Standard Deviation 37.36 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | 5.6 msec | Standard Deviation 26.09 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | -3.0 msec | Standard Deviation 21.29 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | 2.1 msec | Standard Deviation 7.24 |
| Placebo/CC-90001 200mg (PPF Sub-study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | 14.5 msec | Standard Deviation 28.99 |
| Placebo/CC-90001 200mg (PPF Sub-study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | 17.5 msec | Standard Deviation 31.82 |
| Placebo/CC-90001 200mg (PPF Sub-study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | 9.0 msec | Standard Deviation 28.28 |
| Placebo/CC-90001 200mg (PPF Sub-study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | 2.5 msec | Standard Deviation 2.12 |
| Placebo/CC-90001 200mg (PPF Sub-study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | 14.0 msec | Standard Deviation 11.31 |
| Placebo/CC-90001 200mg (PPF Sub-study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | -28.0 msec | Standard Deviation 272.94 |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QRS Duration | 14.5 msec | Standard Deviation 13.44 |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | PR Interval | 2.0 msec | Standard Deviation 7.07 |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcB Interval | 22.5 msec | Standard Deviation 6.36 |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | RR Interval | 15.5 msec | Standard Deviation 135.06 |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QTcF Interval | 23.5 msec | Standard Deviation 4.95 |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period | QT Interval | 25.0 msec | Standard Deviation 26.87 |
Secondary
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period
Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
Time frame: from baseline to week 24
Population: Safety Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QT Interval | -2.9 msec | Standard Deviation 22.37 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcF Interval | -0.3 msec | Standard Deviation 15.12 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcB Interval | 0.5 msec | Standard Deviation 19.57 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | PR Interval | -5.1 msec | Standard Deviation 13.89 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QRS Duration | 2.0 msec | Standard Deviation 8.86 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | RR Interval | -20.9 msec | Standard Deviation 127.25 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | PR Interval | -0.3 msec | Standard Deviation 10.84 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QT Interval | 0.2 msec | Standard Deviation 22.76 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | RR Interval | 6.5 msec | Standard Deviation 127.19 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcF Interval | -0.9 msec | Standard Deviation 13.23 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcB Interval | -1.2 msec | Standard Deviation 16.57 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QRS Duration | 2.1 msec | Standard Deviation 9.65 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QRS Duration | -0.5 msec | Standard Deviation 8.44 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | PR Interval | -0.8 msec | Standard Deviation 12.02 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcB Interval | -2.4 msec | Standard Deviation 18.2 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcF Interval | -2.2 msec | Standard Deviation 16.8 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | RR Interval | 13.0 msec | Standard Deviation 129.92 |
| Placebo (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QT Interval | -1.8 msec | Standard Deviation 26.23 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QRS Duration | -0.9 msec | Standard Deviation 6.74 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | RR Interval | -68.4 msec | Standard Deviation 173.55 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | PR Interval | -5.3 msec | Standard Deviation 12.23 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QT Interval | -9.6 msec | Standard Deviation 30.52 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcB Interval | 7.6 msec | Standard Deviation 23.51 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcF Interval | 1.5 msec | Standard Deviation 16.83 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | PR Interval | 20.5 msec | Standard Deviation 20.51 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | RR Interval | -110.5 msec | Standard Deviation 78.49 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QT Interval | -15.0 msec | Standard Deviation 15.56 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcF Interval | 6.0 msec | Standard Deviation 1.41 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QRS Duration | -3.0 msec | Standard Deviation 4.24 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period | QTcB Interval | 19.0 msec | Standard Deviation 11.31 |
Secondary
Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)
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.
Time frame: From Baseline up to week 24
Population: Full analysis set with evaluable UCSD-SOBQ measures in IPF Cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) | 1.1 Score on a Scale | Standard Deviation 17.28 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) | -3.3 Score on a Scale | Standard Deviation 16.69 |
| Placebo (IPF Study) | Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) | -1.4 Score on a Scale | Standard Deviation 16.19 |
Secondary
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ)
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.
Time frame: From Baseline up to week 24
Population: Full analysis set with evaluable SGRQ measures in IPF Cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Activity | 2.1 Score on a Scale | Standard Deviation 16.95 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Symptoms | 2.0 Score on a Scale | Standard Deviation 21.1 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Impact of disease on daily life | -1.9 Score on a Scale | Standard Deviation 19.31 |
| CC-90001 200mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Total | -0.3 Score on a Scale | Standard Deviation 16.84 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Symptoms | -11.8 Score on a Scale | Standard Deviation 17.57 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Activity | -6.5 Score on a Scale | Standard Deviation 12.72 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Total | -8.6 Score on a Scale | Standard Deviation 15.44 |
| CC-90001 400mg (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Impact of disease on daily life | -8.6 Score on a Scale | Standard Deviation 19.17 |
| Placebo (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Symptoms | -8.3 Score on a Scale | Standard Deviation 20.63 |
| Placebo (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Activity | -4.5 Score on a Scale | Standard Deviation 13.04 |
| Placebo (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Impact of disease on daily life | -1.2 Score on a Scale | Standard Deviation 20.59 |
| Placebo (IPF Study) | Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) | Total | -3.7 Score on a Scale | Standard Deviation 15.99 |
Secondary
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
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.
Time frame: From baseline up to week 104
Population: Full Analysis Set in the IPF cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 | 6.9 meters | Standard Deviation 73.42 |
| CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 52 | -21.9 meters | Standard Deviation 82.57 |
| CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 104 | 0.0 meters | Standard Deviation 1 |
| CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 76 | -9.7 meters | Standard Deviation 58.9 |
| CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 104 | -15.3 meters | Standard Deviation 95.13 |
| CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 52 | 0.2 meters | Standard Deviation 1.02 |
| CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 | -21.1 meters | Standard Deviation 45.8 |
| CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 104 | -25.4 meters | Standard Deviation 58.73 |
| CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 52 | 0.7 meters | Standard Deviation 1.25 |
| CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 104 | -0.3 meters | Standard Deviation 0.42 |
| CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 76 | 3.7 meters | Standard Deviation 46.31 |
| CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 52 | -15.9 meters | Standard Deviation 46.42 |
| Placebo (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 | -8.1 meters | Standard Deviation 49.89 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 104 | -18.6 meters | Standard Deviation 56.24 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 104 | 0.6 meters | Standard Deviation 1.24 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 76 | 14.4 meters | Standard Deviation 25 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 52 | -30.0 meters | Standard Deviation 56.69 |
| Placebo/CC-90001 200mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 52 | -0.9 meters | Standard Deviation 0.88 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 76 | -42.7 meters | Standard Deviation 92.46 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 52 | -29.1 meters | Standard Deviation 94.95 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 104 | -0.1 meters | Standard Deviation 1.66 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Week 24 to Ext Week 52 | 0.7 meters | Standard Deviation 1.59 |
| Placebo/CC-90001 400mg (IPF Study) | Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | Extension Week 104 | -38.7 meters | Standard Deviation 87.8 |
Secondary
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period
Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells
Time frame: From re-randomization to end of treatment (approximately 84 weeks)
Population: Re-Randomized Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 0 Participants |
| Placebo (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 0 Participants |
| Placebo (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 2 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Erythrocytes - Normal to abnormal | 1 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period | Leukocytes - Normal to abnormal | 1 Participants |
Secondary
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period
Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells
Time frame: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Erythrocytes - Normal to Abnormal | 3 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Leukocytes - Normal to Abnormal | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Leukocytes - Normal to Abnormal | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Erythrocytes - Normal to Abnormal | 0 Participants |
| Placebo (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Erythrocytes - Normal to Abnormal | 0 Participants |
| Placebo (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Leukocytes - Normal to Abnormal | 2 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Leukocytes - Normal to Abnormal | 2 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Erythrocytes - Normal to Abnormal | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Leukocytes - Normal to Abnormal | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period | Erythrocytes - Normal to Abnormal | 0 Participants |
Secondary
Number of Participants With Adverse Events at the End of the Active Treatment Phase
Number of participants with Adverse events at the end of the active treatment phase
Time frame: From re-randomization to end of treatment (approximately 84 weeks)
Population: Re-randomized safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 10 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 5 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 25 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 8 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 7 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 2 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 6 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 6 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 23 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 6 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 7 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 13 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 11 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 3 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 13 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 4 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 8 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 2 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 4 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 2 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 2 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 2 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 11 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 1 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 2 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 1 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Severe TEAE | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE related to study Drug | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEA leading to study treatment interruption | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to permanent study treatment discontinuation | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | Serious TEAE | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE leading to Death | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE | 3 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Adverse Events at the End of the Active Treatment Phase | TEAE related to study treatment | 0 Participants |
Secondary
Number of Participants With Adverse Events in the Placebo Controlled Period
Number of participants with Adverse events
Time frame: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to Death | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE related to study Drug | 1 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to permanent study treatment discontinuation | 5 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE | 6 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE | 30 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEA leading to study treatment interruption | 6 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Severe TEAE | 4 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE related to study treatment | 14 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE related to study Drug | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEA leading to study treatment interruption | 3 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Severe TEAE | 8 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE related to study treatment | 21 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to Death | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE | 34 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to permanent study treatment discontinuation | 7 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE related to study Drug | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE related to study treatment | 14 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to Death | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to permanent study treatment discontinuation | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEA leading to study treatment interruption | 5 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE | 31 Participants |
| Placebo (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Severe TEAE | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Severe TEAE | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to Death | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE | 8 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE related to study treatment | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE related to study Drug | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEA leading to study treatment interruption | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to permanent study treatment discontinuation | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to permanent study treatment discontinuation | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEA leading to study treatment interruption | 2 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE related to study treatment | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE | 5 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Severe TEAE | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | TEAE leading to Death | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Adverse Events in the Placebo Controlled Period | Serious TEAE related to study Drug | 0 Participants |
Secondary
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period
Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.
Time frame: From re-randomization to end of treatment (approximately 84 weeks)
Population: Re-randomized safety set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 5 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 14 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 3 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 3 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 1 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 2 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 3 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 5 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 11 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 6 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 2 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 2 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 6 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 1 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Neutrophils - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Hemoglobin - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Basophils - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period | Lymphocytes - Normal to high | 1 Participants |
Secondary
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period
Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.
Time frame: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to low | 1 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to high | 6 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to high | 3 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to high | 4 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to low | 1 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to low | 4 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to low | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to high | 4 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to low | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to high | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to high | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to high | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to low | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to low | 0 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to low | 1 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to high | 10 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to low | 0 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to high | 0 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to low | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to high | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to high | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to low | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to high | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to low | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to high | 3 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to low | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to low | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to high | 7 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to low | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to high | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to high | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to low | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to high | 0 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to high | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to low | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to low | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to high | 2 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to low | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Lymphocytes - Normal to high | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Neutrophils - Normal to high | 2 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Platelets - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to high | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Basophils - Normal to low | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period | Hemoglobin - Normal to low | 0 Participants |
Secondary
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period
Number of participants with worst increase from baseline in systolic and diastolic blood pressure.
Time frame: From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
Population: Re-Randomized Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 5 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 1 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 4 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 6 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 5 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 5 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 8 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 6 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 6 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 4 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 3 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 3 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 5 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 4 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 7 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 4 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 3 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 1 Participants |
| Placebo/CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 4 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 4 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 1 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 0 Participants |
| Placebo/CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 1 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 0 Participants |
| Placebo/CC-90001 200mg (PPF Sub-study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 1 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 15 (severe) | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | systolic increase from baseline > 20 (severe) | 1 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 0 Participants |
| Placebo/CC-90001 400mg (PPF Sub-Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 2 Participants |
Secondary
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period
Number of participants with worst increase from baseline in systolic and diastolic blood pressure.
Time frame: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 2 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 3 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 20 (severe) | 0 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 4 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 3 Participants |
| CC-90001 200mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 15 (severe) | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 15 (severe) | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 0 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 2 Participants |
| CC-90001 400mg (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 20 (severe) | 3 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 15 but ≤ 20 (moderate) | 3 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 20 (severe) | 0 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 5 but ≤ 10 (mild) | 1 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 15 (severe) | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | systolic increase from baseline > 10 but ≤ 15 (mild) | 2 Participants |
| Placebo (IPF Study) | Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period | diastolic increase from baseline > 10 but ≤ 15 (moderate) | 1 Participants |
Secondary
Percentage of Participants Who Had Disease Progression
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.
Time frame: From Baseline up to week 24
Population: Full analysis set in IPF Cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CC-90001 200mg (IPF Study) | Percentage of Participants Who Had Disease Progression | 23.1 Percentage of participants |
| CC-90001 400mg (IPF Study) | Percentage of Participants Who Had Disease Progression | 27.0 Percentage of participants |
| Placebo (IPF Study) | Percentage of Participants Who Had Disease Progression | 25.0 Percentage of participants |