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Idiopathic Pulmonary FibrosisPhase 2NCT03142191

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

A Phase 2 study testing CC-90001 in people with Idiopathic Pulmonary Fibrosis and Fibrosis, run by Celgene at 112 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
CC-90001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
112 sitesin 13 countries
Study dates
26 Jul 2017to 24 Dec 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • History of hepatitis B and/or hepatitis C, including those considered successfully treated/cured
  • Pregnancy or lactation.
  • Additional exclusion criteria apply.

Trial locations and contacts

112 sites in 13 countries.

112 sites in 13 countries

United States21 sites

  • University of Vermont

    Burlington, Vermont, 05405

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Lung and Research Center, LLC

    Chesterfield, Missouri, 63017

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44121

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Local Institution - 502

    Dallas, Texas, 75246

  • Duke University Health System - Duke Pulmonary Transplant Clinic

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32610

  • Loma Linda Univ Medical Center

    Loma Linda, California, 92354

  • Cedars Sinai Medical Center Rheumatology

    Los Angeles, California, 90048

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Miami and Sylvester Cancer Center

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Mt. Sinai School of Medicine

    New York, New York, 10029

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Local Institution - 514

    Sacramento, California, 95817

  • University of California Davis Health System

    Sacramento, California, 95817

  • University of Utah Health Care

    Salt Lake City, Utah, 84132

  • Stanford University Pulmonary and Critical Care Clinic

    Stanford, California, 94305

  • Pulmonary & Sleep Center of Oklahoma

    Tulsa, Oklahoma, 74137

Other trials in United States

Russia17 sites

  • City clinical hospital No 9

    Izhevsk, 426063

  • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascul

    Kemerovo, 650002

  • TSBIH Territorial Clinical Hospital

    Krasnoyarsk, 660022

  • Russian Academy of Medical Sciences RAMS - Central Scientific Research Institute of Tuberculosis CTR

    Moscow, 107564

  • Federal Medico-Biological Agency FMBA - Federal Research Clinical Center FGUZ Clinical Hospital No.

    Moscow

  • Local Institution - 666

    Nizhny Novgorod, 603011

  • Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology

    Nizhny Novgorod, 603011

  • Republican Hospital

    Petrozavodsk, 185019

  • FSBHI Clincial Research Institute of Phithisioplulmonoloyg

    Saint Petersburg, 191036

  • Local Institution - 667

    Saint Petersburg, 191180

  • Vvedenskaya Hospital

    Saint Petersburg, 191180

  • Saint-Petersburg State Institution of Healthcare

    Saint Petersburg, 193312

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • Local Institution - 675

    Saratov, 410053

  • Saratov Regional Clinical Hospital

    Saratov, 410053

  • SAIH of Yaroslavl region Clinical Hospital for Emergency Medical Care n.a. N.V.Solovyev

    Yaroslavl, 150003

  • Ural State Medical Academy - Medical Association Novaya Bolnitsa

    Yekaterinburg, 620109

Other trials in Russia

United Kingdom17 sites

  • Birmingham Chest Clinic

    Birmingham, B3 3HX

  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

    Cottingham, HU16 5JQ

  • Hinchingbrooke Hospital

    Huntingdon, PE29 6NT

  • The Leeds Teaching Hospitals NHS Trust - St James's University Hospital

    Leeds, LS9 7TF

  • University Hospitals of Leicester NHS Trust - Glenfield Hospital - Institute for Lung Health ILH

    Leicester, LE3 9QP

  • Aintree University Hospital

    Liverpool (Walton Centre), L9 7LJ

  • University Hospital Llandough

    Llandough, CF64 2XX

  • University College London Hospitals

    London, NW1 2PG

  • Local Institution - 598

    Newcastle, NE1 4LP

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP

  • Local Institution - 697

    Norwich, NR4 7UY

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • The University of Nottingham - Nottingham Respiratory Research Unit NRRU

    Nottingham, NG5 1PB

  • Salford Royal

    Salford, M6 8HD

  • Southampton General Hospital

    Southhampton, SO01 6YD

  • Local Institution - 694

    Westbury-on-Trym/ Bristol, BS10 5NB

  • Southmead Hospital

    Westbury-on-Trym/ Bristol, BS10 5NB

Other trials in United Kingdom

Australia12 sites

  • Local Institution - 601

    Adelaide, South Australia, 5000

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Local Institution - 608

    Camperdown, New South Wales, 2050

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent Hospital - Sydney

    Darlinghurst, 2010

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Institute for Respiratory Health Inc

    Nedlands, Western Australia, 6009

  • Local Institution - 605

    Parkville, Victoria, 3050

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater Medical Centre

    South Brisbane, Queensland, 4101

Other trials in Australia

Brazil7 sites

  • Clinica de Pneumologia S/S

    Goiânia, Goiás, 74110-030

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90085-074

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital Ernesto Dornelles

    Porto Alegre, 90610-093

  • Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)

    Rio de Janeiro, 21941

  • Faculdade de Medicina do ABC

    Santo André, 09060-650

  • Incor - Instituto do Coracao HCFMUSP

    São Paulo, 01414-001

Other trials in Brazil

Canada6 sites

  • Kelowna & Respiratory Allergy Clinic

    Kelowna, British Columbia, V1W 1V3

  • Local Institution - 621

    Kelowna, British Columbia, V1W 1V3

  • Local Institution - 620

    Vancouver, British Columbia, V5Z 1M9

  • The Lung Centre Respiratory Clinic - Vancouver General Hospital Location

    Vancouver, British Columbia, V5Z 1M9

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

  • Local Institution - 623

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Germany6 sites

  • Helios Klinikum Emil Von Behring

    Berlin, 14165

  • Ruhrlandklinik University Hospital

    Essen, 45239

  • AGAPLESION EV. KRANKENHAUS MITTELHESSEN gGmbH

    Giessen, 35398

  • Local Institution - 642

    Giessen, 35398

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Waldburg-Zeil Kliniken -Fachkliniken Wangen

    Wangen, 88239

Other trials in Germany

Ukraine6 sites

  • Communal Institution Dnipropetrovsk City Clinical Hospital #6 of Dnipropetrovsk Regional Council

    Dnipro, 49023

  • Regional Phthisiopulmonological Center

    Ivano-Frankivsk, 76018

  • Kharkiv City Clinical Hospital #13

    Kharkiv, 61124

  • CI of Healthcare RCH - Center of Medical Emergency and Accident Medicine

    Kharkiv, 61204

  • State Institution National Scientific Center of Radiation Medicine of NAMS of Ukraine

    Kyiv, 03115

  • SI F.H.Yanovskyi National Institute of Phthisiatry and Pulmonology of Academy of Medical Sciences

    Kyiv, 03680

Other trials in Ukraine

Greece5 sites

  • Democritus University of Thrace

    Alexandroupoli, 68100

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • University General Hospital Attikon

    Haidari, 12462

  • University of Crete - University General Hospital of Heraklion

    Heraklion, 711 10

  • General Hospital of Heraklion Benizeleio Pananeio

    Heraklion, 71409

Other trials in Greece

Turkey (Türkiye)5 sites

  • Ege Universitesi Tip Fakultesi Hastanesi Ege University Medical Faculty Hospital

    Bornova, 35100

  • Local Institution - 681

    Bornova, 35100

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16059

  • Istanbul Universitesi - Cerrahpasa Tip Fakultesi Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Izmir Dr.Suat Seren Chest Diseases Hospital

    Izmir, 35100

Other trials in Turkey (Türkiye)

Colombia4 sites

  • Centro de Reumatologia y Ortopedia SAS

    Barranquilla, 080020

  • Local Institution - 631

    Bogotá, 0

  • Centro Especializado en Enfermedades Pulmonares

    Bogotá

  • Centro Medico Imbanaco

    Cali

Other trials in Colombia

Taiwan4 sites

  • Buddhist Dalin Tzu Chi General Hospital

    Dalin, 62247

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, Zhongzheng Dist., 10002

Other trials in Taiwan

Romania2 sites

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj Napoca

    Cluj-Napoca

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara

    Timișoara, 300312

Other trials in Romania

About this study

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

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.

Read the 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.

Being tested
CC-90001, Placebo
Keywords
Idiopathic Pulmonary Fibrosis (IPF), Pulmonary Fibrosis, CC-90001, Safety, Efficacy, IPF, idiopathic pulmonary fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Fibrosis, Idiopathic Interstitial Pneumonias, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases, Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-90001Drug

    CC-90001 is a potent, selective inhibitor of JNK.

  • PlaceboOther

    Placebo

Study groups in NCT03142191
Study groupRoleWhat they receive
CC-90001 400 mg PO QDExperimental55 subjects will be randomized to CC-90001 400mg
Receives: Drug: CC-90001
CC-90001 200 mg PO QDExperimental55 subjects will be randomized to CC-90001 200mg
Receives: Drug: CC-90001
Placebo PO QDPlacebo comparator55 subjects will be randomized to placebo
Receives: Other: Placebo
CC-90001 400 mg PO QD- Sub-StudyExperimental30 subjects will be randomized to CC-90001 400mg
Receives: Drug: CC-90001
Placebo PO QD- Sub-StudyPlacebo comparator15 subjects will be randomized to placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from baseline to week 24

Secondary outcomes (16)

  1. 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.

    Measured: from baseline to week 24

  2. 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.

    Measured: From baseline up to week 104

  3. 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.

    Measured: From baseline up to week 104

  4. 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.

    Measured: From Baseline up to week 24

  5. 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.

    Measured: From Baseline up to week 24

  6. 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.

    Measured: From Baseline up to week 24

  7. 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

    Measured: From re-randomization to end of treatment (approximately 84 weeks)

  8. Number of Participants With Adverse Events in the Placebo Controlled Period

    Number of participants with Adverse events

    Measured: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

  9. 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.

    Measured: From re-randomization to end of treatment (approximately 84 weeks)

  10. 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.

    Measured: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

  11. 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

    Measured: From re-randomization to end of treatment (approximately 84 weeks)

  12. 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

    Measured: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

  13. 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

    Measured: From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)

  14. 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

    Measured: from baseline to week 24

  15. 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.

    Measured: From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)

  16. 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.

    Measured: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start26 Jul 2017
  3. Primary completion24 Dec 2021
  4. Study completion24 Dec 2021

Why it stopped: Business objectives have changed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03142191
Sponsor's protocol ID
CC-90001-IPF-001
Other IDs
2016-003473-17, U1111-1192-8549, 2016
Status last verified
Jun 2023
First submitted
24 Apr 2017
Last updated
28 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38484130

  • 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.

    PubMed 35058236

  • 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.

    PubMed 34894681

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-90001 in people with Idiopathic Pulmonary Fibrosis and Fibrosis, run by Celgene at 112 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Russia, United Kingdom, Australia, Brazil and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). (time frame: from baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03142191, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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Clinical Trial NCT03142191 | AzTrials