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Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImmuneWorks
ClinicalTrials.gov Identifier:
NCT01199887
First received: September 9, 2010
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

This is an open label, Phase One, multicenter study, designed to evaluate the safety, tolerability, to explore the biologic effects, and to explore the clinical effects of the following doses of IW001: 0.1mg/day, 0.5 mg/day, and 1.0 mg/day, when administered once a day orally for 24 weeks in patients with IPF.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: IW001
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:


Further study details as provided by ImmuneWorks:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of three doses of IW001 (0.1 mg/day, 0.5 mg/day, and 1.0 mg/day orally) in patients with IPF patients over a 24 week treatment period. [ Time Frame: Monthly during the 24 week treatment period. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To explore the biologic effects of IW001 on T-cell and B-cell reactivity. To explore relationships between Col V reactivity and clinical measures of lung function in patients with IPF. [ Time Frame: Monthly during the 24 week treatment period. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IW001
Three dose cohorts, 0.1 mg, 0.5 mg, 1.0 mg
Drug: IW001
IW001, 0.1 mg, 0.5 mg, 1.0 mg PO daily for 24 weeks.

Detailed Description:

IW001 is a therapeutic designed to treat anti-Col (V)-mediated autoimmune diseases via oral tolerance. With the identification of the specific antigen involved in the autoimmune disease process in IPF, IW001 induced oral tolerance may be an effective treatment. IW001 is taken orally, introduced into the mucosal immune system at the Peyer's Patches in the distal small intestine, where antigen-presenting cells present the antigen to regulatory T cells (Tregs). These antigen-specific Tregs enter the blood stream and traffic to areas where the specific antigen has generated an autoimmune response. Thus, IW001 may produce selective suppression of immune responses against Col (V).

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet all of the following to be included in the study:

    1. Diagnosis of IPF (ATS criteria) prior to the Baseline visit.
    2. Forced Vital Capacity (FVC) ≥ 50% of predicted.
    3. Lung Diffusion Capacity (DLCO) ≥ 35% of predicted.
    4. Ages 35-75 years inclusive.
    5. Positive for anti-Col (V) antibodies.
    6. White blood cell count (WBC) ≥ 2500 mm3.
    7. Hematocrit ≥ 25% and ≤ 59%.
    8. Platelets ≥ 100,000 mm3.
    9. Creatinine ≤ 1.5x Upper Limits of Normal (ULN).
    10. Bilirubin ≤ 1.5x ULN.
    11. Aspartate aminotransferase (AST, SGOT) ≤ 1.5x ULN.
    12. Females of child-bearing potential (defined as less than one year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence from the time consent is signed until 30 days after treatment discontinuation. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal. Patient must have a negative pregnancy test at the Screening and Baseline visits.
    13. Willing and able to provide adequate written informed consent.

      Exclusion Criteria:

  • Patients will be excluded from the study for any of the following:

    1. Concurrent use of systemic corticosteroids or immunosuppressives within 30 days of the Baseline visit.
    2. Chronic NSAID use (limited, i.e., up to 72 hours continuous use of NSAIDs will be permitted during the study), (see Section 9, concomitant medications).
    3. N-acetyl cysteine (NAC) use within 14 days of the Baseline visit.
    4. Any disease, condition or surgery (e.g. inflammatory bowel disease, surgical resection) that may cause malabsorption of IW001.
    5. Known or suspected allergy to bovine products.
    6. Concurrent or prior use of any experimental medication within 30 days of the Baseline visit.
    7. History of smoking within three months prior to the Baseline visit.
    8. Known Hepatitis C or Human Immunodeficiency Virus (HIV) infections.
    9. Evidence of active infection at the Baseline visit.
    10. History of unstable or deteriorating cardiac disease.
    11. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of the Baseline visit.
    12. Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of the Baseline visit.
    13. Uncontrolled arrhythmia.
    14. Patient has a history of illicit drug or alcohol abuse in the past year or current evidence of such abuse or addiction in the opinion of the Investigator.
    15. Patient has positive findings on urine drug screen.
    16. Any other clinically significant illness, that, in the opinion of the Investigator, might put the patient at risk of harm during the study or might adversely affect the interpretation of the study data.
    17. Females who are pregnant and/or lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199887

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
IUPUI
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Newark Beth Israel Hospital
Newark, New Jersey, United States, 07112
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
ImmuneWorks
Investigators
Study Director: Terrence Chew, MD ImmuneWorks, Medical Consultant
  More Information

Publications:

Responsible Party: ImmuneWorks
ClinicalTrials.gov Identifier: NCT01199887     History of Changes
Other Study ID Numbers: IW001-01
Study First Received: September 9, 2010
Last Updated: July 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmuneWorks:
safety, biologic effects, IPF, autoimmune

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014