Fibrosis, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, Pulmonary Fibrosis
Conditions
Keywords
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, CC-930
Brief summary
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
Interventions
DRUGCC-930
CC-930 50 mg PO daily up to 56 weeks beginning on Day 1
OTHERPlacebo
Placebo
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Week 4 | Number of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression/death rates | Up to week 56 | Time to disease progression and death |
| Pharmacokinetics-Cmax | Week 1 (baseline) and week 2 | Maximum observed concentration in plasma |
| Pharmacokinetics-Cmin | Week 0 (baseline) and week 2 | Minimum observed concentration in plasma |
| Pharmacokinetics-AUC | Week 0 (baseline) and week 2 | Area under the plasma concentration - time curve |
| Long-term safety | Weeks 52-104 | Number of participants with adverse events |
| Pharmacokinetics - t 1/2 | Week 0 (baseline) and week 2 | Terminal half-life (t1/2) |
| Pharmacokinetics-Vz/f | Week 0 (baseline) and week 2 | Apparent volume of distribution |
| Pharmacokinetics-CL/F | Week 0 (baseline) and week 2 | Apparent total body clearance |
| Pharmacokinetics-Tmax | Week 0 (baseline) and week 2 | Time to reach Cmax |
Countries
Canada, United States
Outcome results
None listed