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The benefit/ risk profile does not support continuation of this study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | • 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 | Experimental | • 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 | Experimental | • 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 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-930 | Drug | CC-930 50 mg PO daily up to 56 weeks beginning on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number of participants with adverse events | Week 4 |
| 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 |
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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
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 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
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| Name | Affiliation | Role |
|---|---|---|
| William Smith, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27590145 | Background | 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. |
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| Placebo |
| Other |
Placebo |
|
| CC-930 | Drug | CC-930 100 mg PO daily up to 56 weeks beginning on Day 1 |
|
| CC-930 | Drug | C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1 |
|
| 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 |
| Sacramento |
| California |
| 95817 |
| United States |
| Stanford University, Pulmonary & Critical Care Clinic | Stanford | California | 94305 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33101 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Geisenger Center for Clinical Studies | Danville | Pennsylvania | 17822 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas | Galveston | Texas | 77555 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Vermont Lung Center | Colchester | Vermont | 05446 | United States |
| University of Calgary, Peter Lougheed Centre | Calgary | Alberta | T1Y 6J4 | Canada |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| Vancouver General Hospital/University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Victoria Hospital | London | Ontario | N6A 4G5 | Canada |
| Notre-Dame Hospital du CHUM | Montreal | Quebec | H2L4M1 | Canada |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D005355 | Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C570789 | 4-(9-(tetrahydrofuran-3-yl))-8-(2,4,6-trifluorophenylamino)-9H-purin-2-ylaminocyclohexan-1-ol |
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