Back to resultsA Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Primary Purpose
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-930
Placebo
CC-930
CC-930
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, CC-930
Eligibility Criteria
Inclusion Criteria:
- Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
Diagnosis of IPF based on current ATS/ERS guidelines
- Usual interstitial pneumonia (UIP) pattern on HRCT and/or UIP pattern on histopathology (ie surgical lung biopsy), and
- Exclusion of known causes of interstitial lung disease (such as environmental exposure, connective tissue disease and drug toxicity), Or
- UIP pattern on surgical lung biopsy required if HRCT is inconsistent with UIP
Exclusion Criteria:
- FVC : < 50% predicted >90% predicted
- DLco:< 25% predicted >90% predicted
- Saturated oxygen (SpO2) of <92% (room air [sea level] at rest). SpO2 of < 88% (room air [≥ 5,000 feet above sea level (1524 meters]) at rest)
- Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
Use of any cytokine modulators:
- Use of any biologic agent (such as etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 12 weeks or five half-lives of screening, and in the case of rituximab, use within 24 weeks of screening or no recovery of CD 19-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to screening
- Alefacept within 24 months of randomization
- Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist [eg bosentan, ambrisentan], interferon gamma-1B, pirfenidone) within 4 weeks of screening
- Use of n-acetylcysteine (NAC) for IPF (≥1800 mg/day) within 4 weeks of screening
- Use of any investigational drug within one month of screening, or 5 PD/PK half lives, if known (whichever is longer)
- Current smoker
Sites / Locations
- University of Alabama at Birmingham
- UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
- Stanford University, Pulmonary & Critical Care Clinic
- University of Miami Miller School of Medicine
- University of Louisville
- University of Minnesota
- Mayo Clinic
- Mount Sinai Medical Center
- Duke University Medical Center
- University of Cincinnati
- Geisenger Center for Clinical Studies
- Medical University of South Carolina
- University of Texas
- Baylor College of Medicine
- University of Utah
- Vermont Lung Center
- University of Calgary, Peter Lougheed Centre
- University of Alberta
- Vancouver General Hospital/University of British Columbia
- St. Boniface Hospital
- Victoria Hospital
- Notre-Dame Hospital du CHUM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Placebo
Arm Description
• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM.
• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM
• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1.
Placebo
Outcomes
Primary Outcome Measures
Safety
Number of participants with adverse events
Secondary Outcome Measures
Long-term safety
Number of participants with adverse events
Disease progression/death rates
Time to disease progression and death
Disease progression/death rates
Time to disease progression and death from week 52
Pharmacokinetics-Cmax
Maximum observed concentration in plasma
Pharmacokinetics-Cmin
Minimum observed concentration in plasma
Pharmacokinetics-AUC
Area under the plasma concentration - time curve
Pharmacokinetics-Tmax
Time to reach Cmax
Pharmacokinetics - t 1/2
Terminal half-life (t1/2)
Pharmacokinetics-Vz/f
Apparent volume of distribution
Pharmacokinetics-CL/F
Apparent total body clearance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01203943
Brief Title
A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Official Title
A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
The benefit/ risk profile does not support continuation of this study.
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
January 31, 2012 (Actual)
Study Completion Date
August 24, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial
Keywords
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, CC-930
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CC-930
Intervention Description
CC-930 50 mg PO daily up to 56 weeks beginning on Day 1
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CC-930
Intervention Description
CC-930 100 mg PO daily up to 56 weeks beginning on Day 1
Intervention Type
Drug
Intervention Name(s)
CC-930
Intervention Description
C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1
Primary Outcome Measure Information:
Title
Safety
Description
Number of participants with adverse events
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Long-term safety
Description
Number of participants with adverse events
Time Frame
Weeks 52-104
Title
Disease progression/death rates
Description
Time to disease progression and death
Time Frame
Up to week 56
Title
Disease progression/death rates
Description
Time to disease progression and death from week 52
Time Frame
Weeks 52-104
Title
Pharmacokinetics-Cmax
Description
Maximum observed concentration in plasma
Time Frame
Week 1 (baseline) and week 2
Title
Pharmacokinetics-Cmin
Description
Minimum observed concentration in plasma
Time Frame
Week 0 (baseline) and week 2
Title
Pharmacokinetics-AUC
Description
Area under the plasma concentration - time curve
Time Frame
Week 0 (baseline) and week 2
Title
Pharmacokinetics-Tmax
Description
Time to reach Cmax
Time Frame
Week 0 (baseline) and week 2
Title
Pharmacokinetics - t 1/2
Description
Terminal half-life (t1/2)
Time Frame
Week 0 (baseline) and week 2
Title
Pharmacokinetics-Vz/f
Description
Apparent volume of distribution
Time Frame
Week 0 (baseline) and week 2
Title
Pharmacokinetics-CL/F
Description
Apparent total body clearance
Time Frame
Week 0 (baseline) and week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
Diagnosis of IPF based on current ATS/ERS guidelines
Usual interstitial pneumonia (UIP) pattern on HRCT and/or UIP pattern on histopathology (ie surgical lung biopsy), and
Exclusion of known causes of interstitial lung disease (such as environmental exposure, connective tissue disease and drug toxicity), Or
UIP pattern on surgical lung biopsy required if HRCT is inconsistent with UIP
Exclusion Criteria:
FVC : < 50% predicted >90% predicted
DLco:< 25% predicted >90% predicted
Saturated oxygen (SpO2) of <92% (room air [sea level] at rest). SpO2 of < 88% (room air [≥ 5,000 feet above sea level (1524 meters]) at rest)
Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
Use of any cytokine modulators:
Use of any biologic agent (such as etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 12 weeks or five half-lives of screening, and in the case of rituximab, use within 24 weeks of screening or no recovery of CD 19-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to screening
Alefacept within 24 months of randomization
Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist [eg bosentan, ambrisentan], interferon gamma-1B, pirfenidone) within 4 weeks of screening
Use of n-acetylcysteine (NAC) for IPF (≥1800 mg/day) within 4 weeks of screening
Use of any investigational drug within one month of screening, or 5 PD/PK half lives, if known (whichever is longer)
Current smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Smith, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University, Pulmonary & Critical Care Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Geisenger Center for Clinical Studies
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
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
University of Texas
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
University of Calgary, Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Vancouver General Hospital/University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Notre-Dame Hospital du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27590145
Citation
van der Velden JL, Ye Y, Nolin JD, Hoffman SM, Chapman DG, Lahue KG, Abdalla S, Chen P, Liu Y, Bennett B, Khalil N, Sutherland D, Smith W, Horan G, Assaf M, Horowitz Z, Chopra R, Stevens RM, Palmisano M, Janssen-Heininger YM, Schafer PH. JNK inhibition reduces lung remodeling and pulmonary fibrotic systemic markers. Clin Transl Med. 2016 Dec;5(1):36. doi: 10.1186/s40169-016-0117-2. Epub 2016 Sep 2.
Results Reference
background
Learn more about this trial
A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
We'll reach out to this number within 24 hrs