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

Idiopathic Pulmonary Fibrosis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01203943
• Other study ID #: CC-930-IPF-001
• Status: Terminated
• Phase: Phase 2
• Start date: January 1, 2011
• Est. completion date: August 24, 2012

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: August 24, 2012
• Est. primary completion date: January 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

Drug:
• CC-930
CC-930 50 mg PO daily up to 56 weeks beginning on Day 1

Other:
• Placebo
Placebo

Drug:
• CC-930
CC-930 100 mg PO daily up to 56 weeks beginning on Day 1
• CC-930
C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1

Locations

Country	Name	City	State
Canada	University of Calgary, Peter Lougheed Centre	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Victoria Hospital	London	Ontario
Canada	Notre-Dame Hospital du CHUM	Montreal	Quebec
Canada	Vancouver General Hospital/University of British Columbia	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	Vermont Lung Center	Colchester	Vermont
United States	Geisenger Center for Clinical Studies	Danville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mount Sinai Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University, Pulmonary & Critical Care Clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Number of participants with adverse events	Week 4
Secondary	Long-term safety	Number of participants with adverse events	Weeks 52-104
Secondary	Disease progression/death rates	Time to disease progression and death	Up to week 56
Secondary	Disease progression/death rates	Time to disease progression and death from week 52	Weeks 52-104
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration in plasma	Week 1 (baseline) and week 2
Secondary	Pharmacokinetics-Cmin	Minimum observed concentration in plasma	Week 0 (baseline) and week 2
Secondary	Pharmacokinetics-AUC	Area under the plasma concentration - time curve	Week 0 (baseline) and week 2
Secondary	Pharmacokinetics-Tmax	Time to reach Cmax	Week 0 (baseline) and week 2
Secondary	Pharmacokinetics - t 1/2	Terminal half-life (t1/2)	Week 0 (baseline) and week 2
Secondary	Pharmacokinetics-Vz/f	Apparent volume of distribution	Week 0 (baseline) and week 2
Secondary	Pharmacokinetics-CL/F	Apparent total body clearance	Week 0 (baseline) and week 2