Clinical trial NCT01203943: A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Fibrosis
Interstitial Lung Disease
Lung Diseases, Interstitial
Keywords: Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Fibrosis
Interstitial Lung Disease
Lung Diseases, Interstitial
CC-930
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: Week 4
Secondary outcomes:
measure: Long-term safety
timeFrame: Weeks 52-104
measure: Disease progression/death rates
timeFrame: Up to week 56
measure: Disease progression/death rates
timeFrame: Weeks 52-104
measure: Pharmacokinetics-Cmax
timeFrame: Week 1 (baseline) and week 2
measure: Pharmacokinetics-Cmin
timeFrame: Week 0 (baseline) and week 2
measure: Pharmacokinetics-AUC
timeFrame: Week 0 (baseline) and week 2
measure: Pharmacokinetics-Tmax
timeFrame: Week 0 (baseline) and week 2
measure: Pharmacokinetics - t 1/2
timeFrame: Week 0 (baseline) and week 2
measure: Pharmacokinetics-Vz/f
timeFrame: Week 0 (baseline) and week 2
measure: Pharmacokinetics-CL/F
timeFrame: Week 0 (baseline) and week 2
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
state: California
city: Stanford
country: United States
facility: Stanford University, Pulmonary & Critical Care Clinic
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Danville
country: United States
facility: Geisenger Center for Clinical Studies
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Galveston
country: United States
facility: University of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Colchester
country: United States
facility: Vermont Lung Center
state: Vermont
city: Calgary
country: Canada
facility: University of Calgary, Peter Lougheed Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital/University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
city: Montreal
country: Canada
facility: Notre-Dame Hospital du CHUM
state: Quebec
Study officials:
affiliation: Celgene Corporation
name: William Smith, MD
role: STUDY_DIRECTOR
References:
citation: 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.