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A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-90001
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis (IPF), Pulmonary Fibrosis, CC-90001, Safety, Efficacy, IPF, idiopathic pulmonary fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 exclusion criteria apply.

Sites / Locations

  • Loma Linda Univ Medical Center
  • Cedars Sinai Medical Center Rheumatology
  • Local Institution - 514
  • University of California Davis Health System
  • Stanford University Pulmonary and Critical Care Clinic
  • University of Florida
  • University of Miami and Sylvester Cancer Center
  • University of Louisville
  • The Lung and Research Center, LLC
  • Mt. Sinai School of Medicine
  • Duke University Health System - Duke Pulmonary Transplant Clinic
  • University of Cincinnati Medical Center
  • University Hospitals Cleveland Medical Center
  • Pulmonary & Sleep Center of Oklahoma
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • Baylor University Medical Center
  • Local Institution - 502
  • University of Utah Health Care
  • University of Vermont
  • Local Institution - 608
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • Mater Medical Centre
  • Local Institution - 601
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Local Institution - 605
  • Royal Melbourne Hospital
  • Fiona Stanley Hospital
  • Institute for Respiratory Health Inc
  • St Vincent Hospital - Sydney
  • Clinica de Pneumologia S/S
  • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Hospital Nossa Senhora da Conceicao
  • Hospital Ernesto Dornelles
  • Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
  • Faculdade de Medicina do ABC
  • Incor - Instituto do Coracao HCFMUSP
  • Kelowna & Respiratory Allergy Clinic
  • Local Institution - 621
  • Local Institution - 620
  • The Lung Centre Respiratory Clinic - Vancouver General Hospital Location
  • Dr. Syed Anees Medicine Professional Corporation
  • Local Institution - 623
  • Centro de Reumatologia y Ortopedia SAS
  • Local Institution - 631
  • Centro Especializado en Enfermedades Pulmonares
  • Centro Medico Imbanaco
  • Helios Klinikum Emil Von Behring
  • Ruhrlandklinik University Hospital
  • AGAPLESION EV. KRANKENHAUS MITTELHESSEN gGmbH
  • Local Institution - 642
  • Universitatsklinikum Heidelberg
  • Waldburg-Zeil Kliniken -Fachkliniken Wangen
  • Democritus University of Thrace
  • University General Hospital of Alexandroupolis
  • University General Hospital Attikon
  • General Hospital of Heraklion Benizeleio Pananeio
  • University of Crete - University General Hospital of Heraklion
  • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca
  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara
  • Ural State Medical Academy - Medical Association Novaya Bolnitsa
  • City clinical hospital No 9
  • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul
  • TSBIH Territorial Clinical Hospital
  • Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR
  • Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.
  • Local Institution - 666
  • Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
  • Republican Hospital
  • FSBHI Clincial Research Institute of Phithisioplulmonoloyg
  • Pavlov First Saint Petersburg State Medical University
  • Local Institution - 675
  • Saratov Regional Clinical Hospital
  • Local Institution - 667
  • Vvedenskaya Hospital
  • Saint-Petersburg State Institution of Healthcare
  • SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev
  • Buddhist Dalin Tzu Chi General Hospital
  • Kaohsiung Medical University Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital
  • Local Institution - 681
  • Uludag Universitesi Tip Fakultesi
  • Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty
  • Izmir Dr.Suat Seren Chest Diseases Hospital
  • Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council
  • Regional Phthisiopulmonological Center
  • Kharkiv City Clinical Hospital #13
  • CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine
  • State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine
  • SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences
  • Birmingham Chest Clinic
  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
  • Hinchingbrooke Hospital
  • The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
  • University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH
  • Aintree University Hospital
  • University Hospital Llandough
  • University College London Hospitals
  • Local Institution - 598
  • Royal Victoria Infirmary
  • Local Institution - 697
  • Norfolk and Norwich University Hospital
  • The University of Nottingham - Nottingham Respiratory Research Unit NRRU
  • Salford Royal
  • Southampton General Hospital
  • Local Institution - 694
  • Southmead Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

CC-90001 400 mg PO QD

CC-90001 200 mg PO QD

Placebo PO QD

CC-90001 400 mg PO QD- Sub-Study

Placebo PO QD- Sub-Study

Arm Description

55 subjects will be randomized to CC-90001 400mg

55 subjects will be randomized to CC-90001 200mg

55 subjects will be randomized to placebo

30 subjects will be randomized to CC-90001 400mg

15 subjects will be randomized to placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
Number of Participants With Adverse Events in the Placebo Controlled Period
Number of participants with Adverse events
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.
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.
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
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
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
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
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.
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.

Full Information

First Posted
April 24, 2017
Last Updated
June 6, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03142191
Brief Title
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Official Title
A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Business objectives have changed.
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases
Keywords
Idiopathic Pulmonary Fibrosis (IPF), Pulmonary Fibrosis, CC-90001, Safety, Efficacy, IPF, idiopathic pulmonary fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-90001 400 mg PO QD
Arm Type
Experimental
Arm Description
55 subjects will be randomized to CC-90001 400mg
Arm Title
CC-90001 200 mg PO QD
Arm Type
Experimental
Arm Description
55 subjects will be randomized to CC-90001 200mg
Arm Title
Placebo PO QD
Arm Type
Placebo Comparator
Arm Description
55 subjects will be randomized to placebo
Arm Title
CC-90001 400 mg PO QD- Sub-Study
Arm Type
Experimental
Arm Description
30 subjects will be randomized to CC-90001 400mg
Arm Title
Placebo PO QD- Sub-Study
Arm Type
Placebo Comparator
Arm Description
15 subjects will be randomized to placebo
Intervention Type
Drug
Intervention Name(s)
CC-90001
Intervention Description
CC-90001 is a potent, selective inhibitor of JNK.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC).
Description
Mean change from baseline in percentage point difference in % predicted forced vital capacity (FVC) FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.
Time Frame
from baseline to week 24
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Absolute Forced Vital Capacity (FVC).
Description
Mean change from baseline in absolute FVC in the full analysis set (FAS) population. FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.
Time Frame
from baseline to week 24
Title
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
Description
Mean change in distance walked in the 6-minute Walk Test (6MWT) The 6MWT measures the distance a participant is able to walk on a hard, flat surface, over a total of six minutes. The time points which will be measured are from baseline to Week 24, Extension Week 52, Extension Week 76, Extension Week 104, Week 24 to extension (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
Title
Mean Change From Baseline in Dyspnea Rating on Borg Scale
Description
Mean change from baseline in dyspnea rating on Borg Scale after the 6MWT. The Borg scale ranges from 0 to 10. Where 0 is no dyspnea and a 10 is extremely strong dyspnea. The lower the number the better. 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
Title
Percentage of Participants Who Had Disease Progression
Description
Disease progression is defined as one or more of the following: Death from respiratory failure, Absolute decrease of ≥ 10% from baseline in % predicted FVC at two consecutive evaluations at a minimum of 4 weeks between evaluations Decrease from baseline of ≥ 50 meters in 6MWT distance (in the absence of a readily explainable cause, such as injury or trauma). Unexplained worsening hypoxemia (an absolute decrease from baseline of 4% or more in arterial oxygen saturation by pulse oximetry [SpO2]). FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.
Time Frame
From Baseline up to week 24
Title
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ)
Description
The SGRQ is a quality of life health questionnaire that has been validated in IPF. It consists of 76 items in three domains: Symptoms Activity Impact of disease on daily life A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment). In addition to the total score, there is also a score for each domain: symptoms, activity, and impact which are scored 0-100. Each component score is derived by dividing the summed weights, unique for all questions, by the maximum possible weight.
Time Frame
From Baseline up to week 24
Title
Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)
Description
The UCSD-SOBQ is a 24-item dyspnea questionnaire that asks participants to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness") in two areas: 1) how short of breath they are while performing various activities (21 items); and 2) how much shortness of breath, fear of hurting themselves by overexerting, and fear of shortness of breath limit them in their daily lives (3 items). If the subject does not routinely perform the activity, they are asked to estimate the degree of shortness of breath anticipated. The UCSD-SOBQ is scored by summing responses across all 24 items to form a total score. Scores range from 0 to 120. The lower the score the better.
Time Frame
From Baseline up to week 24
Title
Number of Participants With Adverse Events at the End of the Active Treatment Phase
Description
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)
Title
Number of Participants With Adverse Events in the Placebo Controlled Period
Description
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)
Title
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period
Description
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)
Title
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period
Description
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)
Title
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period
Description
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)
Title
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period
Description
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)
Title
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period
Description
Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
Time Frame
From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
Title
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period
Description
Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval
Time Frame
from baseline to week 24
Title
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period
Description
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)
Title
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject understands and has voluntarily signed and dated an informed consent form Subject is male or female ≥ 40 years of age Diagnosis of IPF is supported by HRCT and historical lung biopsy (surgical lung biopsy [SLB] or cryobiopsy) if available according to guidelines. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed. Percent predicted forced vital capacity (% FVC) ≥ 45% and ≤ 95% at Screening Percent predicted diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 25% and ≤ 90% predicted at Screening. Able to walk ≥ 150 meters during the 6-minute walk test (6MWT) at Screening Females of childbearing potential (FCBP) must commit to true abstinence or agree to use two effective birth control methods. Male subjects must practice true abstinence or use a barrier method of contraception. Additional inclusion criteria apply. Progressive Pulmonary Fibrosis (PPF) Sub-Study: Met all inclusion criteria described for IPF subjects other than Inclusion Criterion 5. Features of diffuse fibrosing lung disease of > 10% on HRCT by central reading. 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: Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Subject with a QTcF > 450 msec. Evidence of clinically relevant airways obstruction at Screening. Subjects using therapy targeted to treat IPF. History of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment History of hepatitis B and/or hepatitis C, including those considered successfully treated/cured Pregnancy or lactation. Additional exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda Univ Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Cedars Sinai Medical Center Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Institution - 514
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University Pulmonary and Critical Care Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami and Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Lung and Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Health System - Duke Pulmonary Transplant Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Pulmonary & Sleep Center of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 502
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Local Institution - 608
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Mater Medical Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution - 601
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution - 605
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Institute for Respiratory Health Inc
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
St Vincent Hospital - Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Clinica de Pneumologia S/S
City
Goiania
State/Province
Goiás
ZIP/Postal Code
74110-030
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90085-074
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
ZIP/Postal Code
90610-093
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
City
Rio de Janeiro
ZIP/Postal Code
21941
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Incor - Instituto do Coracao HCFMUSP
City
Sao Paulo
ZIP/Postal Code
01414-001
Country
Brazil
Facility Name
Kelowna & Respiratory Allergy Clinic
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 1V3
Country
Canada
Facility Name
Local Institution - 621
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 1V3
Country
Canada
Facility Name
Local Institution - 620
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
The Lung Centre Respiratory Clinic - Vancouver General Hospital Location
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Dr. Syed Anees Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Local Institution - 623
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Centro de Reumatologia y Ortopedia SAS
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Local Institution - 631
City
Bogotá
ZIP/Postal Code
0
Country
Colombia
Facility Name
Centro Especializado en Enfermedades Pulmonares
City
Bogotá
Country
Colombia
Facility Name
Centro Medico Imbanaco
City
Cali
Country
Colombia
Facility Name
Helios Klinikum Emil Von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Ruhrlandklinik University Hospital
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
AGAPLESION EV. KRANKENHAUS MITTELHESSEN gGmbH
City
Giessen
ZIP/Postal Code
35398
Country
Germany
Facility Name
Local Institution - 642
City
Giessen
ZIP/Postal Code
35398
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Waldburg-Zeil Kliniken -Fachkliniken Wangen
City
Wangen Im Allgaeu
ZIP/Postal Code
88239
Country
Germany
Facility Name
Democritus University of Thrace
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
University General Hospital of Alexandroupolis
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
University General Hospital Attikon
City
Haidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Heraklion Benizeleio Pananeio
City
Heraklion
ZIP/Postal Code
71409
Country
Greece
Facility Name
University of Crete - University General Hospital of Heraklion
City
Iraklio
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca
City
Cluj-Napoca
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara
City
Timisoara
ZIP/Postal Code
300312
Country
Romania
Facility Name
Ural State Medical Academy - Medical Association Novaya Bolnitsa
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
City clinical hospital No 9
City
Izhevsk
ZIP/Postal Code
426063
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
TSBIH Territorial Clinical Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR
City
Moscow
ZIP/Postal Code
107564
Country
Russian Federation
Facility Name
Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.
City
Moscow
Country
Russian Federation
Facility Name
Local Institution - 666
City
Nizhny Novgorod
ZIP/Postal Code
603011
Country
Russian Federation
Facility Name
Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
City
Nizhny Novgorod
ZIP/Postal Code
603011
Country
Russian Federation
Facility Name
Republican Hospital
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
FSBHI Clincial Research Institute of Phithisioplulmonoloyg
City
Saint Petersburg
ZIP/Postal Code
191036
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution - 675
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Saratov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Local Institution - 667
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Vvedenskaya Hospital
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Saint-Petersburg State Institution of Healthcare
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Buddhist Dalin Tzu Chi General Hospital
City
Dalin
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei, Zhongzheng Dist.
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital
City
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution - 681
City
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Uludag Universitesi Tip Fakultesi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Izmir Dr.Suat Seren Chest Diseases Hospital
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council
City
Dnipro
ZIP/Postal Code
49023
Country
Ukraine
Facility Name
Regional Phthisiopulmonological Center
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Kharkiv City Clinical Hospital #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Facility Name
State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Birmingham Chest Clinic
City
Birmingham
ZIP/Postal Code
B3 3HX
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Hinchingbrooke Hospital
City
Huntingdon
ZIP/Postal Code
PE29 6NT
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool (Walton Centre)
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
University Hospital Llandough
City
Llandough
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Local Institution - 598
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Local Institution - 697
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
The University of Nottingham - Nottingham Respiratory Research Unit NRRU
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Salford Royal
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southhampton
ZIP/Postal Code
SO01 6YD
Country
United Kingdom
Facility Name
Local Institution - 694
City
Westbury-on-Trym/ Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Southmead Hospital
City
Westbury-on-Trym/ Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35058236
Citation
Popmihajlov Z, Sutherland DJ, Horan GS, Ghosh A, Lynch DA, Noble PW, Richeldi L, Reiss TF, Greenberg S. CC-90001, a c-Jun N-terminal kinase (JNK) inhibitor, in patients with pulmonary fibrosis: design of a phase 2, randomised, placebo-controlled trial. BMJ Open Respir Res. 2022 Jan;9(1):e001060. doi: 10.1136/bmjresp-2021-001060.
Results Reference
derived
PubMed Identifier
34894681
Citation
Nagy MA, Hilgraf R, Mortensen DS, Elsner J, Norris S, Tikhe J, Yoon W, Paisner D, Delgado M, Erdman P, Haelewyn J, Khambatta G, Xu L, Romanow WJ, Condroski K, Bahmanyar S, McCarrick M, Benish B, Blease K, LeBrun L, Moghaddam MF, Apuy J, Canan SS, Bennett BL, Satoh Y. Discovery of the c-Jun N-Terminal Kinase Inhibitor CC-90001. J Med Chem. 2021 Dec 23;64(24):18193-18208. doi: 10.1021/acs.jmedchem.1c01716. Epub 2021 Dec 13.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

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