A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
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Brief Summary
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The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.

Official Title
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A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Pulmonary Fibrosis, Fibrosis, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial

Intervention / Treatment
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* Drug: CC-930
* Other: Placebo
* Drug: CC-930
* Drug: CC-930


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM. | Drug: CC-930<br>* CC-930 50 mg PO daily up to 56 weeks beginning on Day 1<br>|
| Experimental: Cohort 2<br>• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM | Drug: CC-930<br>* CC-930 100 mg PO daily up to 56 weeks beginning on Day 1<br>|
| Experimental: Cohort 3<br>• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1. | Drug: CC-930<br>* C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of participants with adverse events | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety | Number of participants with adverse events | Weeks 52-104 | 
| Disease progression/death rates | Time to disease progression and death | Up to week 56 | 
| Disease progression/death rates | Time to disease progression and death from week 52 | Weeks 52-104 | 
| Pharmacokinetics-Cmax | Maximum observed concentration in plasma | Week 1 (baseline) and week 2 | 
| Pharmacokinetics-Cmin | Minimum observed concentration in plasma | Week 0 (baseline) and week 2 | 
| Pharmacokinetics-AUC | Area under the plasma concentration - time curve | Week 0 (baseline) and week 2 | 
| Pharmacokinetics-Tmax | Time to reach Cmax | Week 0 (baseline) and week 2 | 
| Pharmacokinetics - t 1/2 | Terminal half-life (t1/2) | Week 0 (baseline) and week 2 | 
| Pharmacokinetics-Vz/f | Apparent volume of distribution | Week 0 (baseline) and week 2 | 
| Pharmacokinetics-CL/F | Apparent total body clearance | Week 0 (baseline) and week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial, CC-930