Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
