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

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

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

Study Overview

• Status: Terminated
• Conditions: Fibrosis; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases, Interstitial; Interstitial Lung Disease
• Intervention / Treatment: Other: Placebo; Drug: CC-930; Drug: CC-930; Drug: CC-930

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 6J4
      • University of Calgary, Peter Lougheed Centre
    • Edmonton, Alberta, Canada, T6G 2C8
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital/University of British Columbia
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • Victoria Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2L4M1
      • Notre-Dame Hospital du CHUM
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center, Division of Pulmonary and Critical Care Medicine
    • Stanford, California, United States, 94305
      • Stanford University, Pulmonary & Critical Care Clinic
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami Miller School of Medicine
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisenger Center for Clinical Studies
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Vermont
    • Colchester, Vermont, United States, 05446
      • Vermont Lung Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Placebo
EXPERIMENTAL: Cohort 1; • 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; CC-930 50 mg PO daily up to 56 weeks beginning on Day 1; Drug: CC-930; CC-930 100 mg PO daily up to 56 weeks beginning on Day 1; Drug: CC-930; C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1
EXPERIMENTAL: Cohort 2; • 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; CC-930 50 mg PO daily up to 56 weeks beginning on Day 1; Drug: CC-930; CC-930 100 mg PO daily up to 56 weeks beginning on Day 1; Drug: CC-930; C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1
EXPERIMENTAL: Cohort 3; • 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; CC-930 50 mg PO daily up to 56 weeks beginning on Day 1; Drug: CC-930; CC-930 100 mg PO daily up to 56 weeks beginning on Day 1; Drug: CC-930; C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celgene

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): January 31, 2012
• Study Completion (ACTUAL): August 24, 2012

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (ESTIMATE): September 17, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Fibrosis; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Interstitial Lung Disease; Lung Diseases, Interstitial; CC-930
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Fibrosis; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: CC-930-IPF-001