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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
3 other identifiers
interventional
138
13 countries
112
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2017
Typical duration for phase_2
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2021
CompletedResults Posted
Study results publicly available
June 28, 2023
CompletedJune 28, 2023
June 1, 2023
4.4 years
April 24, 2017
December 22, 2022
June 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
Mean Change From Baseline in Absolute Forced Vital Capacity (FVC).
from baseline to week 24
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
From baseline up to week 104
Mean Change From Baseline in Dyspnea Rating on Borg Scale
From baseline up to week 104
Percentage of Participants Who Had Disease Progression
From Baseline up to week 24
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ)
From Baseline up to week 24
- +11 more secondary outcomes
Study Arms (5)
CC-90001 400 mg PO QD
EXPERIMENTAL55 subjects will be randomized to CC-90001 400mg
CC-90001 200 mg PO QD
EXPERIMENTAL55 subjects will be randomized to CC-90001 200mg
Placebo PO QD
PLACEBO COMPARATOR55 subjects will be randomized to placebo
CC-90001 400 mg PO QD- Sub-Study
EXPERIMENTAL30 subjects will be randomized to CC-90001 400mg
Placebo PO QD- Sub-Study
PLACEBO COMPARATOR15 subjects will be randomized to placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Progressive Pulmonary Fibrosis (PPF) Sub-Study:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (112)
Loma Linda Univ Medical Center
Loma Linda, California, 92354, United States
Cedars Sinai Medical Center Rheumatology
Los Angeles, California, 90048, United States
Local Institution - 514
Sacramento, California, 95817, United States
University of California Davis Health System
Sacramento, California, 95817, United States
Stanford University Pulmonary and Critical Care Clinic
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami and Sylvester Cancer Center
Miami, Florida, 33136, United States
University of Louisville
Louisville, Kentucky, 40202, United States
The Lung and Research Center, LLC
Chesterfield, Missouri, 63017, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Duke University Health System - Duke Pulmonary Transplant Clinic
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44121, United States
Pulmonary & Sleep Center of Oklahoma
Tulsa, Oklahoma, 74137, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Local Institution - 502
Dallas, Texas, 75246, United States
University of Utah Health Care
Salt Lake City, Utah, 84132, United States
University of Vermont
Burlington, Vermont, 05405, United States
Local Institution - 608
Camperdown, New South Wales, 2050, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Mater Medical Centre
South Brisbane, Queensland, 4101, Australia
Local Institution - 601
Adelaide, South Australia, 5000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Local Institution - 605
Parkville, Victoria, 3050, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Institute for Respiratory Health Inc
Nedlands, Western Australia, 6009, Australia
St Vincent Hospital - Sydney
Darlinghurst, 2010, Australia
Clinica de Pneumologia S/S
Goiânia, Goiás, 74110-030, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90085-074, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90610-093, Brazil
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, 21941, Brazil
Faculdade de Medicina do ABC
Santo André, 09060-650, Brazil
Incor - Instituto do Coracao HCFMUSP
São Paulo, 01414-001, Brazil
Kelowna & Respiratory Allergy Clinic
Kelowna, British Columbia, V1W 1V3, Canada
Local Institution - 621
Kelowna, British Columbia, V1W 1V3, Canada
Local Institution - 620
Vancouver, British Columbia, V5Z 1M9, Canada
The Lung Centre Respiratory Clinic - Vancouver General Hospital Location
Vancouver, British Columbia, V5Z 1M9, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3, Canada
Local Institution - 623
Windsor, Ontario, N8X 1T3, Canada
Centro de Reumatologia y Ortopedia SAS
Barranquilla, 080020, Colombia
Local Institution - 631
Bogotá, 0, Colombia
Centro Especializado en Enfermedades Pulmonares
Bogotá, Colombia
Centro Medico Imbanaco
Cali, Colombia
Helios Klinikum Emil Von Behring
Berlin, 14165, Germany
Ruhrlandklinik University Hospital
Essen, 45239, Germany
AGAPLESION EV. KRANKENHAUS MITTELHESSEN gGmbH
Giessen, 35398, Germany
Local Institution - 642
Giessen, 35398, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
Waldburg-Zeil Kliniken -Fachkliniken Wangen
Wangen, 88239, Germany
Democritus University of Thrace
Alexandroupoli, 68100, Greece
University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
University General Hospital Attikon
Haidari, 12462, Greece
University of Crete - University General Hospital of Heraklion
Heraklion, 711 10, Greece
General Hospital of Heraklion Benizeleio Pananeio
Heraklion, 71409, Greece
Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca
Cluj-Napoca, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara
Timișoara, 300312, Romania
City clinical hospital No 9
Izhevsk, 426063, Russia
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul
Kemerovo, 650002, Russia
TSBIH Territorial Clinical Hospital
Krasnoyarsk, 660022, Russia
Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR
Moscow, 107564, Russia
Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.
Moscow, Russia
Local Institution - 666
Nizhny Novgorod, 603011, Russia
Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
Nizhny Novgorod, 603011, Russia
Republican Hospital
Petrozavodsk, 185019, Russia
FSBHI Clincial Research Institute of Phithisioplulmonoloyg
Saint Petersburg, 191036, Russia
Local Institution - 667
Saint Petersburg, 191180, Russia
Vvedenskaya Hospital
Saint Petersburg, 191180, Russia
Saint-Petersburg State Institution of Healthcare
Saint Petersburg, 193312, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
Local Institution - 675
Saratov, 410053, Russia
Saratov Regional Clinical Hospital
Saratov, 410053, Russia
SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev
Yaroslavl, 150003, Russia
Ural State Medical Academy - Medical Association Novaya Bolnitsa
Yekaterinburg, 620109, Russia
Buddhist Dalin Tzu Chi General Hospital
Dalin, 62247, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist., 10002, Taiwan
Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital
Bornova, 35100, Turkey (Türkiye)
Local Institution - 681
Bornova, 35100, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Bursa, 16059, Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Izmir Dr.Suat Seren Chest Diseases Hospital
Izmir, 35100, Turkey (Türkiye)
Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council
Dnipro, 49023, Ukraine
Regional Phthisiopulmonological Center
Ivano-Frankivsk, 76018, Ukraine
Kharkiv City Clinical Hospital #13
Kharkiv, 61124, Ukraine
CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine
Kharkiv, 61204, Ukraine
State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine
Kyiv, 03115, Ukraine
SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences
Kyiv, 03680, Ukraine
Birmingham Chest Clinic
Birmingham, B3 3HX, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, HU16 5JQ, United Kingdom
Hinchingbrooke Hospital
Huntingdon, PE29 6NT, United Kingdom
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds, LS9 7TF, United Kingdom
University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH
Leicester, LE3 9QP, United Kingdom
Aintree University Hospital
Liverpool (Walton Centre), L9 7LJ, United Kingdom
University Hospital Llandough
Llandough, CF64 2XX, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
Local Institution - 598
Newcastle, NE1 4LP, United Kingdom
Royal Victoria Infirmary
Newcastle, NE1 4LP, United Kingdom
Local Institution - 697
Norwich, NR4 7UY, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
The University of Nottingham - Nottingham Respiratory Research Unit NRRU
Nottingham, NG5 1PB, United Kingdom
Salford Royal
Salford, M6 8HD, United Kingdom
Southampton General Hospital
Southhampton, SO01 6YD, United Kingdom
Local Institution - 694
Westbury-on-Trym/ Bristol, BS10 5NB, United Kingdom
Southmead Hospital
Westbury-on-Trym/ Bristol, BS10 5NB, United Kingdom
Related Publications (3)
Mattos WLLD, Khalil N, Spencer LG, Bonella F, Folz RJ, Rolf JD, Mogulkoc N, Lancaster LH, Jenkins RG, Lynch DA, Noble PW, Maher TM, Cottin V, Senger S, Horan GS, Greenberg S, Popmihajlov Z. Phase 2, Double-Blind, Placebo-controlled Trial of a c-Jun N-Terminal Kinase Inhibitor in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2024 Aug 15;210(4):435-443. doi: 10.1164/rccm.202310-1907OC.
PMID: 38484130DERIVEDPopmihajlov 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.
PMID: 35058236DERIVEDNagy 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.
PMID: 34894681DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2017
First Posted
May 5, 2017
Study Start
July 26, 2017
Primary Completion
December 24, 2021
Study Completion
December 24, 2021
Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06