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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03142191




Registration number
NCT03142191
Ethics application status
Date submitted
24/04/2017
Date registered
5/05/2017
Date last updated
28/06/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Scientific 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
Secondary ID [1] 0 0
2016-003473-17
Secondary ID [2] 0 0
CC-90001-IPF-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Fibrosis 0 0
Idiopathic Interstitial Pneumonias 0 0
Pathologic Processes 0 0
Lung Diseases, Interstitial 0 0
Lung Diseases 0 0
Respiratory Tract Diseases 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-90001
Other interventions - Placebo

Experimental: CC-90001 400 mg PO QD - 55 subjects will be randomized to CC-90001 400mg

Experimental: CC-90001 200 mg PO QD - 55 subjects will be randomized to CC-90001 200mg

Placebo comparator: Placebo PO QD - 55 subjects will be randomized to placebo

Experimental: CC-90001 400 mg PO QD- Sub-Study - 30 subjects will be randomized to CC-90001 400mg

Placebo comparator: Placebo PO QD- Sub-Study - 15 subjects will be randomized to placebo


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

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC).
Timepoint [1] 0 0
from baseline to week 24
Secondary outcome [1] 0 0
Mean Change From Baseline in Absolute Forced Vital Capacity (FVC).
Timepoint [1] 0 0
from baseline to week 24
Secondary outcome [2] 0 0
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
Timepoint [2] 0 0
From baseline up to week 104
Secondary outcome [3] 0 0
Mean Change From Baseline in Dyspnea Rating on Borg Scale
Timepoint [3] 0 0
From baseline up to week 104
Secondary outcome [4] 0 0
Percentage of Participants Who Had Disease Progression
Timepoint [4] 0 0
From Baseline up to week 24
Secondary outcome [5] 0 0
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ)
Timepoint [5] 0 0
From Baseline up to week 24
Secondary outcome [6] 0 0
Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)
Timepoint [6] 0 0
From Baseline up to week 24
Secondary outcome [7] 0 0
Number of Participants With Adverse Events at the End of the Active Treatment Phase
Timepoint [7] 0 0
From re-randomization to end of treatment (approximately 84 weeks)
Secondary outcome [8] 0 0
Number of Participants With Adverse Events in the Placebo Controlled Period
Timepoint [8] 0 0
from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Secondary outcome [9] 0 0
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period
Timepoint [9] 0 0
From re-randomization to end of treatment (approximately 84 weeks)
Secondary outcome [10] 0 0
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period
Timepoint [10] 0 0
from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Secondary outcome [11] 0 0
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period
Timepoint [11] 0 0
From re-randomization to end of treatment (approximately 84 weeks)
Secondary outcome [12] 0 0
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period
Timepoint [12] 0 0
from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)
Secondary outcome [13] 0 0
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period
Timepoint [13] 0 0
From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
Secondary outcome [14] 0 0
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period
Timepoint [14] 0 0
from baseline to week 24
Secondary outcome [15] 0 0
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period
Timepoint [15] 0 0
From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)
Secondary outcome [16] 0 0
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period
Timepoint [16] 0 0
from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/12/2021
Sample size
Target
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 608 - Camperdown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Mater Medical Centre - South Brisbane
Recruitment hospital [5] 0 0
Local Institution - 601 - Adelaide
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
Local Institution - 605 - Parkville
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [11] 0 0
Institute for Respiratory Health Inc - Nedlands
Recruitment hospital [12] 0 0
St Vincent Hospital - Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
Brazil
State/province [15] 0 0
Goiás
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande Do Sul
Country [17] 0 0
Brazil
State/province [17] 0 0
Porto Alegre
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio de Janeiro
Country [19] 0 0
Brazil
State/province [19] 0 0
Santo Andre
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Colombia
State/province [23] 0 0
Barranquilla
Country [24] 0 0
Colombia
State/province [24] 0 0
Bogotá
Country [25] 0 0
Colombia
State/province [25] 0 0
Cali
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Giessen
Country [29] 0 0
Germany
State/province [29] 0 0
Heidelberg
Country [30] 0 0
Germany
State/province [30] 0 0
Wangen Im Allgaeu
Country [31] 0 0
Greece
State/province [31] 0 0
Alexandroupolis
Country [32] 0 0
Greece
State/province [32] 0 0
Haidari
Country [33] 0 0
Greece
State/province [33] 0 0
Heraklion
Country [34] 0 0
Greece
State/province [34] 0 0
Iraklio
Country [35] 0 0
Romania
State/province [35] 0 0
Cluj-Napoca
Country [36] 0 0
Romania
State/province [36] 0 0
Timisoara
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Ekaterinburg
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Izhevsk
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Kemerovo
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Krasnoyarsk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Nizhny Novgorod
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Petrozavodsk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Saint Petersburg
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Saint-Petersburg
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Saratov
Country [47] 0 0
Russian Federation
State/province [47] 0 0
St. Petersburg
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Yaroslavl
Country [49] 0 0
Taiwan
State/province [49] 0 0
Dalin
Country [50] 0 0
Taiwan
State/province [50] 0 0
Kaohsiung
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taichung City
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei, Zhongzheng Dist.
Country [53] 0 0
Turkey
State/province [53] 0 0
Bornova
Country [54] 0 0
Turkey
State/province [54] 0 0
Bursa
Country [55] 0 0
Turkey
State/province [55] 0 0
Istanbul
Country [56] 0 0
Turkey
State/province [56] 0 0
Izmir
Country [57] 0 0
Ukraine
State/province [57] 0 0
Dnipro
Country [58] 0 0
Ukraine
State/province [58] 0 0
Ivano-Frankivsk
Country [59] 0 0
Ukraine
State/province [59] 0 0
Kharkiv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Kyiv
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Birmingham
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Cottingham
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Huntingdon
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Leeds
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Leicester
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Liverpool (Walton Centre)
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Llandough
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Newcastle
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Norwich
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Nottingham
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Salford
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Southhampton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Westbury-on-Trym/ Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03142191