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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pathologic Processes; Fibrosis; Respiratory Tract Diseases; Lung Diseases; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias
• Intervention / Treatment: Other: Placebo; Drug: CC-90001

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
    • St Vincent Hospital - Sydney
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Camperdown, New South Wales, Australia, 2050
      • Local Institution - 608
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Medical Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 601
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3050
      • Local Institution - 605
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Nedlands, Western Australia, Australia, 6009
      • Institute for Respiratory Health Inc
• Brazil
  • Porto Alegre, Brazil, 90610-093
    • Hospital Ernesto Dornelles
  • Rio de Janeiro, Brazil, 21941
    • Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
  • Santo Andre, Brazil, 09060-650
    • Faculdade de Medicina do ABC
  • Sao Paulo, Brazil, 01414-001
    • Incor - Instituto do Coracao HCFMUSP
  • Goiás
    • Goiania, Goiás, Brazil, 74110-030
      • Clinica de Pneumologia S/S
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora Da Conceicao
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90085-074
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 1V3
      • Kelowna & Respiratory Allergy Clinic
    • Kelowna, British Columbia, Canada, V1W 1V3
      • Local Institution - 621
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • The Lung Centre Respiratory Clinic - Vancouver General Hospital Location
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Local Institution - 620
  • Ontario
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Syed Anees Medicine Professional Corporation
    • Windsor, Ontario, Canada, N8X 1T3
      • Local Institution - 623
• Colombia
  • Barranquilla, Colombia, 080020
    • Centro de Reumatologia y Ortopedia SAS
  • Bogotá, Colombia
    • Centro Especializado en Enfermedades Pulmonares
  • Bogotá, Colombia
    • Local Institution - 631
  • Cali, Colombia
    • Centro Medico Imbanaco
• Germany
  • Berlin, Germany, 14165
    • Helios Klinikum Emil Von Behring
  • Essen, Germany, 45239
    • Ruhrlandklinik University Hospital
  • Giessen, Germany, 35398
    • AGAPLESION EV. KRANKENHAUS MITTELHESSEN gGmbH
  • Giessen, Germany, 35398
    • Local Institution - 642
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Wangen Im Allgaeu, Germany, 88239
    • Waldburg-Zeil Kliniken -Fachkliniken Wangen
• Greece
  • Alexandroupolis, Greece, 68100
    • Democritus University of Thrace
  • Alexandroupolis, Greece, 68100
    • University General Hospital of Alexandroupolis
  • Haidari, Greece, 12462
    • University General Hospital Attikon
  • Heraklion, Greece, 71409
    • General Hospital of Heraklion Benizeleio Pananeio
  • Iraklio, Greece, 711 10
    • University of Crete - University General Hospital of Heraklion
• Romania
  • Cluj-Napoca, Romania
    • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca
  • Timisoara, Romania, 300312
    • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara
• Russian Federation
  • Ekaterinburg, Russian Federation, 620109
    • Ural State Medical Academy - Medical Association Novaya Bolnitsa
  • Izhevsk, Russian Federation, 426063
    • City clinical hospital No 9
  • Kemerovo, Russian Federation, 650002
    • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul
  • Krasnoyarsk, Russian Federation, 660022
    • TSBIH Territorial Clinical Hospital
  • Moscow, Russian Federation, 107564
    • Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR
  • Moscow, Russian Federation
    • Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.
  • Nizhny Novgorod, Russian Federation, 603011
    • Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
  • Nizhny Novgorod, Russian Federation, 603011
    • Local Institution - 666
  • Petrozavodsk, Russian Federation, 185019
    • Republican Hospital
  • Saint Petersburg, Russian Federation, 191036
    • FSBHI Clincial Research Institute of Phithisioplulmonoloyg
  • Saint-Petersburg, Russian Federation, 197022
    • Pavlov First Saint Petersburg State Medical University
  • Saratov, Russian Federation, 410053
    • Saratov Regional Clinical Hospital
  • Saratov, Russian Federation, 410053
    • Local Institution - 675
  • St. Petersburg, Russian Federation, 191180
    • Vvedenskaya hospital
  • St. Petersburg, Russian Federation, 193312
    • Saint-Petersburg State Institution of Healthcare
  • St. Petersburg, Russian Federation, 191180
    • Local Institution - 667
  • Yaroslavl, Russian Federation, 150003
    • SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev
• Taiwan
  • Dalin, Taiwan, 62247
    • Buddhist Dalin Tzu Chi General Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital
  • Taichung City, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Zhongzheng Dist., Taiwan, 10002
    • National Taiwan University Hospital
• Turkey
  • Bornova, Turkey, 35100
    • Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital
  • Bornova, Turkey, 35100
    • Local Institution - 681
  • Bursa, Turkey, 16059
    • Uludag Universitesi Tip Fakultesi
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty
  • Izmir, Turkey, 35100
    • Izmir Dr.Suat Seren Chest Diseases Hospital
• Ukraine
  • Dnipro, Ukraine, 49023
    • Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council
  • Ivano-Frankivsk, Ukraine, 76018
    • Regional Phthisiopulmonological Center
  • Kharkiv, Ukraine, 61124
    • Kharkiv city clinical hospital #13
  • Kharkiv, Ukraine, 61204
    • CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine
  • Kyiv, Ukraine, 03115
    • State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine
  • Kyiv, Ukraine, 03680
    • SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences
• United Kingdom
  • Birmingham, United Kingdom, B3 3HX
    • Birmingham Chest Clinic
  • Cottingham, United Kingdom, HU16 5JQ
    • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
  • Huntingdon, United Kingdom, PE29 6NT
    • Hinchingbrooke Hospital
  • Leeds, United Kingdom, LS9 7TF
    • The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
  • Leicester, United Kingdom, LE3 9QP
    • University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH
  • Liverpool (Walton Centre), United Kingdom, L9 7LJ
    • Aintree University Hospital
  • Llandough, United Kingdom, CF64 2XX
    • University Hospital Llandough
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals
  • Newcastle, United Kingdom, Ne1 4LP
    • Royal Victoria Infirmary
  • Newcastle, United Kingdom, NE1 4LP
    • Local Institution - 598
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Local Institution - 697
  • Nottingham, United Kingdom, NG5 1PB
    • The University of Nottingham - Nottingham Respiratory Research Unit NRRU
  • Salford, United Kingdom, M6 8HD
    • Salford Royal
  • Southhampton, United Kingdom, SO01 6YD
    • Southampton General Hospital
  • Westbury-on-Trym/ Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Westbury-on-Trym/ Bristol, United Kingdom, BS10 5NB
    • Local Institution - 694
• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda Univ Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center Rheumatology
    • Sacramento, California, United States, 95817
      • University of California Davis Health System
    • Sacramento, California, United States, 95817
      • Local Institution - 514
    • Stanford, California, United States, 94305
      • Stanford University Pulmonary and Critical Care Clinic
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami and Sylvester Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Lung and Research Center, LLC
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai School of Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System - Duke Pulmonary Transplant Clinic
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44121
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Pulmonary & Sleep Center of Oklahoma
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75246
      • Local Institution - 502
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CC-90001 400 mg PO QD; 55 subjects will be randomized to CC-90001 400mg	Drug: CC-90001; CC-90001 is a potent, selective inhibitor of JNK.
Experimental: CC-90001 200 mg PO QD; 55 subjects will be randomized to CC-90001 200mg	Drug: CC-90001; CC-90001 is a potent, selective inhibitor of JNK.
Placebo Comparator: Placebo PO QD; 55 subjects will be randomized to placebo	Other: Placebo; Placebo
Experimental: CC-90001 400 mg PO QD- Sub-Study; 30 subjects will be randomized to CC-90001 400mg	Drug: CC-90001; CC-90001 is a potent, selective inhibitor of JNK.
Placebo Comparator: Placebo PO QD- Sub-Study; 15 subjects will be randomized to placebo	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from baseline to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from baseline to week 24
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.	From baseline up to week 104
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.	From baseline up to week 104
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.	From Baseline up to week 24
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.	From Baseline up to week 24
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.	From Baseline up to week 24
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	From re-randomization to end of treatment (approximately 84 weeks)
Number of Participants With Adverse Events in the Placebo Controlled Period	Number of participants with Adverse events	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 During the Active Treatment Extension Period	Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.	From re-randomization to end of treatment (approximately 84 weeks)
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.	from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
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	From re-randomization to end of treatment (approximately 84 weeks)
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	from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
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	From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
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	from baseline to week 24
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.	From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
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.	from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2017
• Primary Completion (Actual): December 24, 2021
• Study Completion (Actual): December 24, 2021

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; idiopathic pulmonary fibrosis; IPF; Idiopathic Pulmonary Fibrosis (IPF); Pulmonary Fibrosis; CC-90001
• Additional Relevant MeSH Terms: Fibrosis; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Respiratory Tract Diseases; Idiopathic Interstitial Pneumonias; Hamman-Rich Syndrome; Pathologic Processes
• Other Study ID Numbers: CC-90001-IPF-001; 2016-003473-17 (EudraCT Number); U1111-1192-8549 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No